Sedation for oocyte retrieval using target ... - Wiley Online Library

Anaesthesia, 2010, 65, pages 453–461 doi:10.1111/j.1365-2044.2010.06264.x .....................................................................................................................................................................................................................

ORIGINAL ARTICLE

Sedation for oocyte retrieval using target controlled infusion of propofol and incremental alfentanil delivered by non-anaesthetists J. A. Edwards,1 J. Kinsella,2 A. Shaw,3 S. Evans3 and K. J. Anderson4 1 Clinical Research Fellow, 2 Professor, 3 Nurse Practitioner, 4 Consultant, Department of Anaesthesia, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK Summary

Oocyte retrieval is a procedure where sedation is recommended. This paper presents the process of setting up a new, non-anaesthetist delivered service in our institution, the development of safety systems and the audit data we have used to assure quality, effectiveness and safety. Logbook data were collected for 4342 cases, with detailed audit data collected for 260 cases. Safety is acceptable with a respiratory adverse incident rate of 0.5 ⁄ 1000 (95% CI 0.1–1.6 ⁄ 1000 cases). Unplanned, direct anaesthetic assistance was required in 3.5 ⁄ 1000 cases (95% CI 1.7–5.3 ⁄ 1000 cases). Anaesthetic advice was required in 7.5% cases (95% CI 4.2–10.7%) at the inception of the service, but rarely once established: 0.6% (95% CI 0.2–1.0%). Nearly all patients (99%) would have the same sedation method again, no patients required admission, and patients’ co-operation was judged by the operating surgeon as very good or good in 91% of cases. . ......................................................................................................

Correspondence to: Dr Keith Anderson E-mail: [email protected] Accepted: 6 January 2010

Oocyte retrieval during assisted conception is performed using transvaginal ultrasound guided follicular puncture as a day case procedure, for which conscious sedation is recommended [1]. In a recent Cochrane Review of conscious sedation and analgesia for oocyte retrieval, no one method was found to be superior in terms of pregnancy outcomes, pain relief, and patient satisfaction [2]. Propofol has been used safely and successfully for sedation in sub-anaesthetic doses, and appears to be safe for use in assisted conception [3–5]. There is evidence of both non-anaesthetic trained physicians and nurses using propofol for sedation with no increase in adverse outcomes [6, 7]. In-hospital sedation for oocyte retrieval was previously provided by a single, non-consultant, career grade anaesthetist. This anaesthetist resigned, the advertised post received no applicants and there was no funding to upgrade these sessions to consultant anaesthetic sessions. Because nurse sedation had been used for endoscopic procedures, there was managerial interest in developing a 2010 The Authors Journal compilation 2010 The Association of Anaesthetists of Great Britain and Ireland

system using non-medical healthcare professionals to deliver conscious sedation. A consultant anaesthetist (KA) with a background in sedation research was asked to develop the service. We describe the method of setting up this service and the audit used to assure the quality, safety and effectiveness of this non-standard sedation technique. Methods

Two non-medical sedationists were recruited; one was an operating department practitioner with an engineering degree, the other was a theatre sister with anaesthetic experience and a masters degree; both were registered with their professional bodies. Training was designed, organised and delivered by a consultant anaesthetist (KA) to cover knowledge and skills necessary for the post (Table 1). The theoretical aspect was taught face to face by the consultant for 1 h for 12 weeks. This was assessed by formal written assessment in short-answer question 453

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J. A. Edwards et al. Target controlled sedation delivered by non-anaesthetists Anaesthesia, 2010, 65, pages 453–461 . ....................................................................................................................................................................................................................

Table 1 Topics covered during training of non-medical seda-

tionists. Knowledge

Skills

Anaesthetic machine & equipment Pre-operative assessment

Assessment of sedation level

Emergency drugs Drugs for sedation including O2 Protocols Observations & monitoring Critical incidents: anaphylaxis ⁄ allergy ⁄ over sedation

Airway skills: bag and mask ventilation, laryngeal mask use Intravenous cannulation Immediate life support

format and filling in blanks on protocol sheets. The pass mark was arbitrarily set at 75%. Both of the sedationists scored over 90%. The practical skills were taught and assessed in theatre under direct observation with other consultants and this was assessed by logbook. Practical training ran concurrently whereby sedationists observed a consultant anaesthetist conducting conscious sedation by protocol (Appendix 1) for a period of 1 week, followed by 50 cases each under direct supervision. Thereafter, they provided sedation per protocol under remote anaesthetic supervision (within 2 min). Sedationists also had to continue to demonstrate their competency at rescue airway management by managing 10 elective airways with manual ventilation by facemask and inserting 10 laryngeal mask airways (LMAs) per month under anaesthetic supervision. Patients’ assessment for suitability to receive protocol sedation was performed by a medical member of staff using the screening sheet (Appendix 2); those with contra-indications were referred to the lead consultant anaesthetist. The assisted conception suite is remote to main theatres (one floor away in the same building). Therefore, immediate assistance in the event of an emergency was provided by a trainee (usually specialist trainee year 3 (ST3) and above) doubled up with a consultant, who was on call for the main theatre recovery room and sedation suite through a rapid response paging system. Sedationists had to verify this paging system was working before commencing the sedation list each day. Patients arrived for their procedure fasted; a preoperative assessment was performed by the sedationist (Appendix 3) who explained that they were not doctors but staff trained to provide sedation for this procedure. Postoperative analgesia was given before the procedure (100 mg oral dispersible diclofenac and 1 g oral dispersible paracetamol at least 30 min before the procedure). Sedation drugs were prescribed by a medical member of staff (gynaecologist or anaesthetist) and prepared by the sedationist. Propofol 1% in a 50-ml syringe was mixed 454

with 2 ml lidocaine 1%. Alfentanil 1000 lg was diluted in sterile water to a total volume of 10 ml. Patients were connected to standard monitoring (ECG, non-invasive blood pressure, pulse oximetry and expired CO2 via nasal sponge) and 4 l.min)1 oxygen was given via a Hudson mask. The sedationist confirmed target controlled infusion operation on the propofol pump ((initially Graseby 3500 DiprifusorTM (Graseby Medical, Watford, UK), changed in 2007 to Alaris PK (CareFusion, San Diego, CA, USA); both using Marsh kinetics), and entered the patient’s weight and age. Intravenous access was obtained, and sedation and analgesia was commenced and titrated according to the protocol (Appendix 1). Patients in whom propofol was contra-indicated were given intravenous incremental midazolam followed by incremental alfentanil (Appendix 1). Observation and assessment of airway, breathing, circulation and sedation level were continuous and recorded at 5-min intervals. The on-call anaesthetist was contacted for advice or help, and before any breaches of the protocol. The proposed training scheme, protocols and systems were reviewed and approved at anaesthetic directorate level by the clinical director, service manager and lead nurse; and at a trust level by the medical director and clinical governance committee. Provision of non-medical sedation started in June 2004. Audit The Local Research Ethics Committee confirmed that these data were audit and could be presented if anonymised. Primary audit data on the provision of safe sedation (defined as maintaining conscious sedation at all times [8]) were collected on all cases. It was assessed by measurement of Objective Observers Assessment of Sedation Score [9] (over sedation was defined as sedation score 1–3; see Appendix 1), and by measurement of surrogates of over sedation (SpO2 £ 92% or the need for an airway opening manoeuvre). Secondary audit data of patient satisfaction were assessed by a patients’ questionnaire. Data were obtained from two sources: logbook data and detailed audit data.The first were collected prospectively Table 2 Data fields included in the logbook of non-medical sedationists. Date Patients’ characteristics; date of birth, weight, ID number Procedure type and duration Total propofol dose, total alfentanil dose Lowest sedation score Unsafe endpoints e.g. airway intervention, SpO2 < 93% Anaesthetic assistance ⁄ advice required Clinical incidents e.g. bleeding, drug reactions

2010 The Authors Journal compilation 2010 The Association of Anaesthetists of Great Britain and Ireland

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Anaesthesia, 2010, 65, pages 453–461 J. A. Edwards et al. Target controlled sedation delivered by non-anaesthetists . ....................................................................................................................................................................................................................

from the inception of the service for every case by the sedationist, in paper format (Table 2). Detailed audit data were collected during two audit periods; each audit period lasted 3 months and data were collected prospectively on consecutive patients. In the first period, 5 months after the service started, 169 cases were audited to confirm that the service was effective and safe. This was repeated in a further 91 patients, 18 months after the service commenced. The stimulus for this was an increasing number of procedures that were lasting more than 30 min (requiring greater doses of alfentanil, after discussion with an anaesthetist). Audit data were obtained from three sources per case (Table 3): information recorded by the sedationist; surgical questionnaires; and patients’ questionnaires. The questions were devised by the lead consultant; answers were ranked on an interval scale. Data were initially recorded in paper format, then collated by the sedationist and uploaded onto an ACCESS database (Microsoft, Redmond, WA, USA). A third party checked the accuracy of the transcription of the data from paper to electronic format for the detailed audit data. Quality check of the electronic data was performed by the lead consultant during statistical analysis. Results

Logbook data of 4342 patients revealed no episodes of arterial oxygen desaturation, one airway event and one episode of transient apnoea (without arterial oxygen desaturation). This equates to an airway ⁄ respiration incident rate of 0.5 ⁄ 1000 cases (95% CI 0.1–1.6 ⁄ 1000 cases). In the airway event, the sedationist went to perform a jaw thrust but the patient roused and did not require any airway adjuncts or further intervention. One patient, who maintained verbal contact (sedation score 5) Table 3 Information collected during period of audit of nonmedical sedation service. Person recording data Sedationist

Surgeon

Patient

Advice required Intervention required Weight; kg Total propofol; mg Total alfentanil; lg

Ease of procedure Patient co-operation Opinion on sedation

Sedation satisfaction Choose same again? Level of pain relief Nausea Pain level of propofol injection Overall rating

Max propofol plasma level; lg.ml)1 Max propofol effect site level; lg.ml)1

Recall: Anything IV cannulation Scan Cannulation ovary


and normal arterial oxygen saturation, displayed excess sensitivity to alfentanil boluses manifest by short periods of apnoea detected on capnograph monitoring of the respiratory rate. No further alfentanil was given, and subsequent sedation was delivered safely with propofol alone under direct supervision. An anaesthetist was physically present (but not administering sedation) on six occasions: three times for a transabdominal surgical approach; twice to supervise sedation in patients with severe epilepsy; and once to provide analgesia for a patient who was not fasted and so not suitable for the standard sedation protocol. Unplanned direct anaesthetic assistance was required 15 times; this is a rate of 0.35% or 3.5 ⁄ 1000 cases (95% CI 1.7– 5.3 ⁄ 1000 cases). These 15 episodes comprised: six times when patients became disinhibited or unco-operative during sedation (allowing anaesthesia to be instituted in one patient); four times to assist with venous access; three times for assessment of the patient during surgical bleeding; and once each to assess patients with anaphylaxis (to diclofenac), intra-operative ectopic beats on ECG, resistant postoperative pain, and severe postoperative nausea. We audited 260 cases in depth of which 255 had a complete dataset. All were of ASA physical status 1 or 2, with a mean (SD) weight of 66.1 (9.6) kg. There were no cases of over sedation, no cases required airway intervention, and there were no episodes of desaturation below 93%. Advice from an anaesthetist was required for 19 (7.5%) cases (95% CI 4.2–10.7%), and no cases required direct anaesthetic intervention. The doses of sedative drugs used are detailed in Table 4. Nine patients (3.5%, 95% CI 1.3–5.8%) required > 2.0 lg.ml)1 propofol. A postoperative questionnaire was completed by 255 patients, of whom 253 (99%) would have the same sedation again. Nausea in recovery was reported by 28 patients but none required admission. Pain on injection of propofol was generally acceptable, but was moderate or severe in 1.6% of patients, and overall satisfaction was high with only 1.5% of patients describing the procedure as unpleasant (Table 5). The surgeons’ rating of the ease of procedure and patients’ co-operation are detailed in Table 6. Re-analysis of the anaesthetic advice rate was performed from the last 18-month period (1408 logbook Table 4 Duration of procedure and drug doses used during conscious sedation. Values are mean (SD [range]). n Duration; min Propofol Cp maximum; lg.ml)1 Propofol total dose; mg Alfentanil total dose; lg

91 260 260 260

33.7 1.69 173 1173

(10.9 [15.0–65.0]) (0.28 [1.00–2.70]) (50 [51–348]) (329 [500–2700])

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Table 5 Results of the patients’ postoperative questionnaires of non-anaesthetic sedationists. Values are number (%). Pain on infusion of propofol? Overall pain score None Mild Moderate Severe Total Overall experience Don’t remember Excellent Not unpleasant Unpleasant Horrible Total

23 ⁄ 260 (8.8%) 227 (87.5%) 24 (9.2%) 2 (0.8%) 2 (0.8%) 255* 25 (9.8%) 155 (59.6%) 71 (27.3%) 4 (1.5%) 0 255*

*Does not include missing data from five patients.

Table 6 Results of the surgeons’ postoperative questionnaires. Values are number (%). Ease of procedure Easy Mild difficulty Difficult Very difficult Patient co-operation Very good Good Average Minimal

200 (76.9%) 37 (14.2%) 20 (7.7%) 3 (1.2%) 213 (81.9%) 29 (11.2%) 16 (6.2%) 2 (0.8%)

cases). Advice was requested for eight patients equating to 0.6% (95% CI 0.2–1.0%). Discussion

We have demonstrated that conscious sedation using propofol and alfentanil provided by non-medical sedationists can be both safe and effective. To date, there have been no cases of arterial oxygen desaturation and only one case of transient need for airway support, and one case of alfentanil sensitivity leading to short periods of apnoea (without arterial oxygen saturation or over sedation). Both of these cases were dealt with safely within the competencies of the trained sedationists and the medical support systems in place. This equates to an airway ⁄ respiratory incident rate of 0.5 ⁄ 1000 cases. The estimated upper limit of the 95% CI of an adverse respiratory events occurring was 1.6 ⁄ 1000 cases [10]. This compares favourably with those reported by doctors of 4.1 ⁄ 1000 for general practitioners and 2.6 ⁄ 1000 for anaesthetists [6]. Furthermore, unplanned anaesthetic assistance was required infrequently (3.5 ⁄ 1000 cases) and arrived in a timely manner. Although a consultant anaesthetist is not directly present during provision of sedation, they are still responsible for supervision of the service. Medical advice 456

was required in 7.5% of cases in the first 18-months of the service. However, this rate did improve with time; data from the most recent 18-month period estimate advice being required from medical staff in 0.6% of cases. This highlights that such a service does not run itself when set up and considerable medical input is necessary, especially in the early stages, to ensure the safe provision of care. Our paper describes results obtained from analysis of prospective audit of practice. There are potential shortcomings about drawing conclusions based on these types of data: whereas the logbook data are continuous, prospectively collected and complete, the in-depth audit data are not continuous; also neither sources of data were blinded. We have not compared non-anaesthetist sedation with other methods of provision of sedation, but have focussed on ensuring the quality of the sedation protocol we have been using and comparing this to published results. However, we believe that the large number of prospective cases analysed and the multisource origin of the data allows us to conclude that we are providing a safe and effective service according to the standards set by the Academy of Royal Colleges document on safe sedation practice [8]. Although there is some precedent of non-anaesthetists’ providing propofol sedation without increases in adverse outcomes [6, 7], in the UK, anaesthesia and anaesthetic drugs are traditionally delivered by medically qualified anaesthetists. Recently, a new non-medical member of the anaesthetic team has been developed, the Physicians’ Assistant (Anaesthesia) or PA(A). They perform duties delegated to them by their medical anaesthetic supervisor and have clearly defined limits to their practice [11]. The sedationist role we have developed is distinct to that of the PA(A)s. Our sedationists deliver conscious sedation and maintain verbal contact with the patients at all time; their role is not to provide general anaesthesia. Training is in-house, lasts 3 months, and is procedure specific; explicitly their role as a sedationist is not transferable to other areas. Physicians’ Assistant (Anaesthesia) undergo training for 27 months on a nationally approved programme following a nationally agreed curriculum, leading to the simultaneous award of a Postgraduate Diploma in Anaesthetic Practice and Affiliate of the Royal College of Anaesthetists [12]. The sedationists trained at our institution would not be able to undertake the work of a PA(A); however, we believe a PA(A) could provide conscious sedation using a model similar to ours. This service was set up before the syllabus for PA(A)s was available. Therefore a significant difficulty in setting up the service was the lack of direct guidance on what the structure and content there should be for training nonanaesthetist sedationists. The Academy of Royal Colleges document is not much help [8]; it merely states: ‘Royal 2010 The Authors Journal compilation 2010 The Association of Anaesthetists of Great Britain and Ireland

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Colleges and their Faculties should incorporate the necessary instruction and assessment into training and revalidation programmes of those specialties that use sedation techniques’. As a practical recommendation it suggests that: ‘each hospital should appoint two consultants (one an anaesthetist and the other a user of sedation from another speciality) to lead and support implementation of their recommendations on sedation at hospital level’. The National Confidential Enquiry into Patient Outcome and Death has also dealt directly with the necessity of training of those providing sedation [13], but is equally vague about the required content, and refers back to the guidelines of the Academy of Medical Royal Colleges. It does elaborate that lead consultants for sedation should be able to review sedation practices within their Trust, identify deficiencies in sedation training in colleagues and trainees, and respond to them. The training programme was therefore devised by the lead consultant based on the broad topics deemed necessary for training dental sedationists [14]. These were made specific to the protocol and the level of detail was similar to the syllabus for the Fellow of the Royal College of Anaesthetists examination (Table 1). There is a seemingly never-ending desire within the National Health Service in the UK to extend the roles of nurses and other non-medical staff into services traditionally provided by doctors. Anaesthetists are no different to other specialties in this respect. Although these developments are usually pushed through on the back of problems with workforce planning, the reality is that these are usually financially driven. It is our duty as clinicians to be guardians of clinical governance, in short, demanding that these developments are high-quality and safe. As part of this, we need to consider the legal issues pertinent to those being trained. In the UK, propofol is only licensed for use by ‘those trained in anaesthesia’. However, in the strict legal sense it is not necessary, under British or Irish law, to be medically qualified to dispense medical treatment or, indeed specifically to administer anaesthesia. It is mandatory, however, that the patient is aware of the status of the person providing medical treatment [15]. The Academy of Royal Colleges make it clear that those who administer sedative drugs are aware of the possible adverse consequences and are able to deal with these [8]. Propofol is increasingly used for procedural sedation by non-anaesthetists in emergency departments. Accident and emergency (A&Es) departments continue to draw inferences of ‘safety’ after describing sedation with propofol in limited numbers (without reference to 95% CI) and with little emphasis on maintaining verbal contact [16, 17]. The Academy of Royal Colleges document on safe sedation practice, led by the Royal College of Anaesthetists but with members from all relevant specialties including the Faculty of Accident & Emergency 2010 The Authors Journal compilation 2010 The Association of Anaesthetists of Great Britain and Ireland

Medicine, is very clear on this topic. It states that during conscious sedation, ‘verbal contact with the patient is maintained throughout the period of sedation’, and that provision of sedation deeper than this is bordering on anaesthesia. As such, this depth of sedation must be supervised by those with the same level of training and skills necessary to provide general anaesthesia [8]. Our whole set up was designed to achieve delivery of sedation with verbal contact maintained, and audit delivery of sedation to this standard. In addition, we have sought to describe an accurate estimate of airway and respiratory events in our population. We believe that the results we have obtained are due to the entire package of training, protocol, and anaesthetic support systems. It is our feeling that it would be difficult to obtain similar results if another organisation copied only part of this (e.g. the protocol). It is disappointing that A&E departments administering propofol sedation can erroneously be called safe when the airway event rate is 80 ⁄ 1000 [17], almost 30-fold higher than those described in anaesthetists. It has been stated that safety for alternative or non-standard techniques of sedation should be demonstrated in hundreds of patients [18]. We believe we have done that and more, but that our A&E colleagues fall far short in that respect. Sedation for oocyte retrieval is common in the UK; 84% of units surveyed in 2003 used intravenous sedation for transvaginal egg collection [19]. Use of propofol and alfentanil has been previously described in this population. Dell et al. [20] used an admixture of alfentanil and propofol given via a patient controlled pump with a zero lockout to provide patient controlled conscious sedation during oocyte retrieval. They had no cases of oversedation in their 56 patients studied, had a mean (SD [range]) consumption of propofol per patient of 196 mg (56 [97–341] mg) and of alfentanil of 1.57 mg (0.45 [0.77–2.73] mg). Safety is impossible to infer from their data. However, we have found the mean consumption of these drugs to be lower using our protocol, whilst achieving the same level of patient satisfaction. The protocol was devised by the lead consultant, and it may seem elaborate. It was chosen because of the lead consultant’s background in propofol sedation research, and based on simple pharmacokinetic and dynamic principles used in everyday practice in anaesthesia. However, by nature, it had to be quite prescriptive for use by non-anaesthetic staff. Propofol was chosen as our sedative (hypnotic) drug because it provides superior anxiolysis, quicker recovery, less amnesia and less depression of post-sedation psychomotor function compared with midazolam sedation. A target controlled infusion was used for propofol delivery [21–23]; this requires fewer interventions per case compared with a standard intermittent bolus techniques [24]. The starting propofol 457

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plasma concentration target was set to cause a low likelihood of causing over sedation [4, 25]. Thereafter, propofol sedation was titrated in small increments according to the patients’ response. The main problem in providing sedation for transvaginal oocyte retrieval is that the procedure is painful and requires analgesia as well as hypnosis. Alfentanil was chosen as it is more titratable because of its rapid plasmabrain equilibration (short keo half-life) and doesn’t accumulate even after administration by infusion [26]. The main problem in co-administering hypnotic and opioid is the potential for pharmacokinetic and more importantly pharmacodynamic interaction [27–29]. The minimum times between titration of hypnotic (propofol) and opioid (alfentanil) were modelled using commercially available pharmacokinetic ⁄ pharmacodynamics software (TIVA TRAINER) [30]. The main principle is that propofol and alfentanil are not titrated simultaneously, and time is left after each increment of either drug to allow the clinical effect to catch up with plasma drug level. The suggested times allow for the peak predicted effect-site concentration of each to have equilibrated after each titration to minimise the potential for interaction. This protocol is not put forward as the only suitable protocol, as we believe that the whole package of training, systems of supervision and protocol are necessary to achieve the same results as we have obtained. Future developments of methods for patients’ delivering their own conscious sedation show promise e.g. patient-controlled sedation or patient maintained sedation [31, 32]. They may offer some advantages over current methods of sedation [21] and are clinically effective in small pilot studies [33–37]; however, they are not yet ready for clinical use as despite recent refinements they can still cause over sedation if deliberately stressed [38, 39]. We believe they are not currently suitable for use by non-anaesthetist sedationists until their safety has been demonstrated in far greater numbers. References 1 NICE. Fertility: assessment and treatment for people with fertility problems. National Collaborating Centre for Women’s and Children’s Health for the National Institute of Clinical Excellence; London: RCOG Press, 2004. 2 Kwan I, Bhattacharya S, Knox F, McNeil A. Conscious sedation and analgesia for oocyte retrieval during in vitro fertilisation procedures. Cochrane Database of Systematic Reviews 2005; Issue 3. Art. No.: CD004829. DOI: 10.1002/ 14651858.CD004829.pub2. 3 Skipsey IG, Colvin JR, Mackenzie N, Kenny GN. Sedation with propofol during surgery under local blockade. Assessment of a target-controlled infusion system. Anaesthesia 1993; 48: 210–3.

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34 Leitch JA, Sutcliffe N, Kenny GN. Patient-maintained sedation for oral surgery using a target-controlled infusion of propofol – a pilot study. British Dental Journal 2003; 194: 43–5. 35 Campbell L, Imrie G, Doherty P, et al. Patient maintained sedation for colonoscopy using a target controlled infusion of propofol. Anaesthesia 2004; 59: 127–32. 36 Chapman RM, Anderson K, Green J, Leitch JA, Gambhir S, Kenny GN. Evaluation of a new effect-site controlled, patient-maintained sedation system in dental patients. Anaesthesia 2006; 61: 345–9. 37 Murdoch JA, Grant SA, Kenny GN. Safety of patient-maintained propofol sedation using a target-controlled system in healthy volunteers. British Journal of Anaesthesia 2000; 85: 299–301. 38 Henderson F, Absalom AR, Kenny GN. Patient-maintained propofol sedation: a follow up safety study using a modified system in volunteers. Anaesthesia 2002; 57: 387–90. 39 Anderson KJ, Leitch JA, Green JS, Kenny GN. Effect-site controlled patient maintained propofol sedation: a volunteer safety study. Anaesthesia 2005; 60: 235–8. Appendix 1 Drug administration protocol for nonmedical conscious sedation Start propofol target-controlled infusion (TCI) 1. Start TCI plasma target concentration: CpT of propofol at 1.4 lg.ml)1 2. Wait 2 min then assess sedation scale a. If patient is visibly relaxed reduce CpT propofol to 1.0 lg.ml)1 b. If patient not obviously relaxed continue CpT at 1.4 lg.ml)1 c. Once the patient seems more relaxed, but sedation scale still 4 or 5, commence analgesia Start analgesia with alfentanil 1. When surgeon ready to start give alfentanil 250 lg 2. Allow surgeon to clean and prep, wait at least 2 min before cannulation of each ovary TITRATION OF SEDATION DURING PROCEDURE Alfentanil titration 1. 250 lg given initially and before cannulation of each ovary 2. 100 lg at 1-min intervals at other times, but not within 2 min of giving 250 lg 3. Maximum dose alfentanil 1500 lg 4. If procedure > 30 min, then further 500 lg is allowed. If more, required discuss with on-call anaesthetist Propofol titration for anxiety 1. Increase in 0.2 lg.ml)1 increments every 2 min up to a maximum CpT of 2.0 lg.ml)1 2. If the patient’s sedation score is 3 or less the level should be reduced by 0.2 lg.ml)1 Time limits for titration (never titrate both together) • Wait 2 min after 250 lg and 1 min after 100 lg alfentanil before titrating either alfentanil or propofol • Wait 2 min after starting or titrating propofol before titrating either propofol or alfentanil REASONS TO STOP SEDATION • Patient doesn’t respond to shaking (sedation score 1) • SpO2 < 90% • Patient needs airway support If the pump is stopped, once the patient begins to respond to verbal contact, it should be recommenced at 1.0 lg.ml)1 only after the patient has been assessed by an anaesthetist

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Appendix 1 (Continued)

Appendix 2 (Continued)

Midazolam sedation protocol Substitute midazolam for TCI propofol for those with contra-indications to propofol 1. Give midazolam before alfentanil 2. Do not give any more midazolam once started giving alfentanil 3. Draw 10 mg midazolam up to 10 ml with saline 4. Give midazolam 2 mg initially I.V. then 1 mg at 1-min intervals until the patient looks more relaxed, or is sedation scale 4 Wait 2 min after giving last increment of midazolam before giving alfentanil

• Alfentanil 100–250 lg boluses i.v. (per protocol), maximum dose 1500 lg. 2000 lg in specific situations as detailed • Diclofenac dispersible 100 mg p.o. if patient tolerant of NSAIDS • Paracetamol 1 g p.o. • Dihydrocodeine 60 mg p.o. 4 hourly for postoperative pain • Ondansetron 4 mg I.V. 8 hourly PRN for nausea • Prochlorperazine 12.5 mg i.m. 6 hourly PRN for nausea • Dextrose 1000 ml I.V. over 1 h for nausea

Intravenous or subcutaneous morphine should be discussed with and prescribed by the attending gynaecologist. Sedation Level

Patient Response

5 4 3 2 1

Patient responds readily to voice Patient responds slowly to voice Patient responds to repeatedly calling name Patient responds to gentle shaking No response to shaking

Doctors Signature:

Appendix 2 Screening for suitability for administration for administration of sedation by protocol

Screening for contra-indications to protocol 1. Known allergy to sedative drugs: propofol ⁄ h Yes h No midazolam ⁄ alfentanil 2. History of difficult intubation ⁄ airway surgery h Yes h No 3. Patient not fasted for 6 h h Yes h No 4. Patients with poorly controlled systemic disease h Yes h No i.e. patients whose lifestyle is restricted by the disease If the answer is YES to any of the above, the patient must be assessed by an anaesthetist and the suitability for the protocol decided by them

Suitable but with alterations to protocol 5. Patients with history of epilepsy If yes, these patients should receive protocol using midazolam not propofol 6. Allergy to non-sedative protocol drugs • Diclofenac • Paracetamol • Dihydrocodeine • Ondansetron • Prochlorperazine Patients with an allergy to a non-sedative drug can have EXCEPT FOR THAT DRUG

h Yes h No

The patient detailed above would be suitable to receive the following drugs by the seditionists adhering to the ACS sedation protocol using the following drugs (please cross out any to which the patient is allergic): • Propofol 1% by target controlled infusion I.V. to a maximum level 2.0 lg.ml)1 or midazolam 1–10 mg I.V. by incremental dose at 1-min intervals if unsuitable for propofol

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Appendix 3 Pre-operative assessment for non-medical conscious sedation

Specific anaesthetic problems 1. Past medical history of allergy or anaphylaxis to propofol or alfentanil. 2. Personal history or family history of anaesthetic problems. a) Known difficult intubation: doesn’t preclude sedation but need direct supervision. b) Malignant hyperthermia: not an issue as not using triggers (volatiles or suxamethonium). c) Scoline apnoea: not an issue not using suxamethonium.

General medical problems In general the fitness of a pre-operative patient is assessed with the American Society of Anesthesiologists (ASA) scale; this grades patients regardless of the actual pre-existing medical disease by the severity. ASA 1 ASA 2 ASA 3

h Yes h No h Yes h No h Yes h No h Yes h No h Yes h No the protocol

Date:

ASA 4

ASA 5

Fit and healthy, no significant disease Mild systemic disease that does not alter lifestyle e.g. mild diabetes, asthma, controlled high BP Moderate or severe systemic disease that alters lifestyle e.g. chronic obstructive pulmonary disease (COPD) or angina with limited exercise tolerance Severe systemic disease that is a constant threat to life e.g. COPD with breathlessness at rest, unstable angina (at rest or with rapidly reducing amounts of activity) A patient who is not expected to survive the next 24 h with or without an operation

Obviously most patients in the ambulatory care surgery (ACS) service will be ASA 1 & 2. All patients who are ASA 3 or higher should be discussed with an anaesthetist before sedation. Any uncommon conditions encountered should be discussed with an anaesthetist. 2010 The Authors Journal compilation 2010 The Association of Anaesthetists of Great Britain and Ireland

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Appendix 3 (Continued) Medical problems can be screened easily on anaesthetic form and should be discussed with anaesthetists.

• BP > 150 ⁄ 90 • Angina on minimal exertion (washing ⁄ walking < 100 yds on flat or at rest) Ensure any cardiovascular medications have been taken

1. Cardiac disease

• COPD ⁄ asthma with shortness of breath on minimal exertion • Any recent upper respiratory tract infection (URTI) when still pyrexial or generally unwell needs the chest examined by doctor (gynaecologist is satisfactory) Ensure inhalers have been taken that morning

Diagnosis and treatment of reflux • Sour or acid taste coming into mouth when lies flat or stops to tie shoes etc • Heartburn and indigestion do not constitute reflux alone but they may benefit from antacid prophylaxis • Prophylaxis = 150 mg ranitidine & 10 mg metoclopramide p.o. Put patient to end of list as prophylaxis takes 60–120 min to be effective • Discuss with anaesthetist

2. Respiratory disease

• Anyone with previous brain surgery • Anyone with epilepsy is not suitable for propofol sedation and should have midazolam sedation protocol Ensure they have had anti convulsants that morning

3.Neurological disease

4.Metabolic disease

5. Gastrointestinal disease

• Diabetics should be fasted and be first on list • They should have omitted normal morning insulin or tablets • They should have blood glucose checked before sedation If < 4.0 mmol.l)1 they should have 500 ml of 5% dextrose commenced i.v. • If blood glucose < 3.0 mmol.l)1 discuss with doctor • After sedation they should take normal insulin or tablets 30 min after first meal (to ensure not going to vomit) • The main concern is acid reflux and aspiration while sedated • Patients should be fasted for food 6 h and clear fluid 2 h (except sips for tablets) • Ask patients for symptoms of reflux


Contra-indications to propofol sedation in ACS • Patients with known allergy to propofol, eggs, soyabeans or alfentanil • Patients with known difficult intubation • Patients who are not adequately fasted • Any patients with epilepsy (even if ASA 2): they may receive midazolam sedation

Contra-indications to any sedation • Patients with known difficult intubation • Patients who are not adequately fasted • Patients assessed as ASA 3 or greater

Any doubts should be discussed with an anaesthetist.

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