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  1. 1. CLINICAL UPDATEGuidelines on Sedation and/or Analgesia for Diagnosticand Interventional Medical or Surgical Procedures Sedation Review PS9 (2008) Incorporating PS 24 (Review 2004) Australian and New Zealand Royal Australasian College of Anaethetists College of Surgeons
  2. 2. Table of contents3 Digestive Health Foundation4 Introduction5 Patient preparation5 Patient assessment6 Staffing6 Facilities,including equipment7 Technique and monitoring7 Documentation8 Recovery and discharge8 Training in sedation for gastrointestinal endoscopic procedures9 References10 Appendix I10 Appendix II12 College professional documents
  3. 3. Digestive Health FoundationThe Digestive Health Foundation (DHF) is an educational body committedto promoting better health for all Australians by promoting education andcommunity health programs related to the digestive system.The DHF is the educational arm of the Gastroenterological Society of Australia,the professional body representing the specialty ofgastrointestinal and liverdisease in Australia. Members of the Society are drawn from physicians, surgeons,scientists and other medical specialties with an interest in GI disorders.Since its establishment in 1990 the DHF has been involved in the developmentof programs to improve community awareness and the understandingof digestive diseases.Research and education into gastrointestinal disease are essential to containthe effects of these disorders on all Australians.Guidelines for General Practitioners and patient leaflets are available on a rangeof topics related to GI disorders. Copies are available on the GESA websiteor by contacting the Secretari at at the address below.Digestive Health Foundation145 Macquarie StreetSydney NSW 2000Phone: (02) 9256 5454Facsimile: (02) 9241 4586E-mail:© Copyright. Gastroenterological Society of Australia. March 2008. This booklet is copyright and all rights reserved.It may not be reproduced in whole or in part without permission from the Gastroenterological Society of Australia.
  4. 4. INTRODUCTION 1.1.2 Deep levels of sedation, This document is intended to apply where consciousness is lost wherever procedural sedation and patients only respond and/or analgesia for diagnostic to painful stimulation, are and interventional medical and associated with loss of the surgical procedures are administered, ability to maintain a patent especially where sedation and/ airway, inadequate spontaneous or analgesia may lead to general ventilation and/or impaired anaesthesia. The Australian and cardiovascular function. New Zealand College of Anaesthetists Deep levels of sedation may recognises that practitioners with have similar risks to general diverse qualifications and training anaesthesia, and may require are administering a variety of an equivalent level of care. medications to patients to allow such 1.1.3 Analgesia is reduction or procedures to be performed. elimination of pain This document addresses pertinent perception, usually induced issues for all practitioners involved by drugs which act locally in such activities. (by interfering with nerve conduction) or generally1 DEFINITIONS (by depressing pain 1.1 Procedural sedation and/or analgesia perception in the central implies that the patient is in a state nervous system). of drug-induced permissiveness of 1.2 General Anaesthesia is a drug-induced uncomfortable or painful diagnostic state characterised by absence of or interventional medical or surgical response to any stimulus, loss of procedures. Lack of memory of protective airway reflexes, depression distressing events and/or analgesia of respiration and disturbance of are desired outcomes, but lack of circulatory reflexes. General anaesthesia response to painful stimulation is sometimes indicated during diagnostic is not assured. or interventional medical or surgical 1.1.1 Conscious Sedation is procedures and requires the exclusive defined as a drug-induced attention of an anaesthetist depression of consciousness (see College Professional Document during which patients are T1 – Recommendations on Minimum able to respond purposefully Facilities for Safe Administration of to verbal commands or light Anaesthesia in Operating Suites and tactile stimulation. Other Anaesthetising Locations). No interventions are usually required to maintain a patent 2 AIMS AND RISKS OF PROCEDURAL airway, spontaneous ventilation SEDATION AND/OR ANALGESIA or cardiovascular function. The aims of procedural sedation and/or Conscious sedation may be analgesia are to ensure patient safety achieved by a wide variety of and comfort, and to facilitate completion techniques including propofol of the planned procedure. In order to and may accompany local achieve these aims, a range of sedation anaesthesia. All conscious options may be required during any one sedation techniques should procedure, with a continuum from no provide a margin of safety that medication, through conscious sedation is wide enough to render loss and deep sedation, to general anaesthesia. of consciousness unlikely. Endorsed March 2008 4
  5. 5. While no sedation or conscious sedation with 3 PATIENT PREPARATIONsmall doses of drugs such as benzodiazepines 3.1 The patient should be provided withand opioids are options for some patients written information which includesand proceduralists, many patients and the nature and risks of the procedure,proceduralists want deep levels of sedation preparation instructions (includingor general anaesthesia to be an option during the importance of fasting), and whateach procedure. Practitioners authorised or to expect during the immediate andcredentialled to administer procedural sedation longer term recovery period, includingand/or analgesia should be aware that the after discharge.transition from complete consciousness through 3.2 Informed consent for sedation and/orthe various depths of sedation to general analgesia and for the procedure shouldanaesthesia is a continuum and not a set of be obtained (see College Professionaldiscrete, well-defined stages. Document PS26 – Guidelines on Consent for Anaesthesia or Sedation).The margin of safety of drugs used to achievesedation and/or analgesia varies widely between 4 PATIENT ASSESSMENTpatients and loss of consciousness with its attendant 4.1 All patients should be assessed beforerisk of loss of protective reflexes may occur rapidly procedural sedation and/or analgesia.and unexpectedly. Therefore practitioners who Assessment should include:administer sedative or analgesic drugs that alter 4.1.1 Details of the current problem,the conscious state of a patient must be prepared co-existing and past medicalto manage the following potential risks: and surgical history, history2.1 Depression of protective airway reflexes of previous sedation and and loss of airway patency. anaesthesia, current medications2.2 Depression of respiration. (including non-prescribed2.3 Depression of the cardiovascular system. medications), allergies, fasting2.4 Drug interactions or adverse reactions, status, the presence of false, including anaphylaxis. damaged or loose teeth,2.5 Individual variations in response to the or other evidence of potential drugs used, particularly in children, airway problems. the elderly, and those with pre-existing 4.1.2 Examination, including that medical disease. relevant to the current problem,2.6 The possibility of deeper sedation or of the airway, respiratory and anaesthesia being used to compensate cardiovascular status, and other for inadequate analgesia or local systems as indicated by the history. anaesthesia. 4.1.3 Results of relevant investigations.2.7 Risks inherent in the wide variety of 4.2 This assessment should identify procedures performed under procedural those patients at increased risk of sedation and/or analgesia. cardiovascular, respiratory or airway2.8 Unexpected extreme sensitivity to the compromise during procedural sedation drugs used for procedural sedation and/or analgesia, as in such cases, an and/or analgesia which may result anaesthetist should be present to care in unintentional loss of consciousness, for the patient. These patients include respiratory or cardiovascular depression. the elderly, those with severely limiting Over-sedation, airway obstruction, heart, cerebrovascular, lung, liver or respiratory or cardiovascular renal disease, morbid obesity, significant complications may occur at any time. obstructive sleep apnoea, or known Therefore, to ensure high standards or suspected difficult endotracheal of quality safe patient care, the following intubation, acute gastrointestinal bleeding guidelines are recommended. with cardiovascular compromise or shock, severe anaemia, the potential for aspiration of stomach contents Endorsed March 2008 5
  6. 6. (which may necessitate endotracheal 5.5 Techniques intended to produce deep intubation), previous adverse events due sedation or general anaesthesia must to sedation, analgesia or anaesthesia, not be used unless an anaesthetist is and patients in ASA Grades P 4-5 (see present (see College Professional Appendix I). See also College Professional Documents PS1 Recommendations Document PS7 – Recommendations on on Essential Training for Rural General the Pre-Anaesthesia Consultation. Practitioners in Australia Proposing to Administer Anaesthesia, PS2 Statement5 STAFFING on Credentialling in Anaesthesia, 5.1 There must be a minimum of three PS8 Guidelines on the Assistant to appropriately trained staff present: the Anaesthetist, PS16 Statement the proceduralist, the practitioner on the Standards of Practice of a administering sedation and monitoring Specialist Anaesthetist, TE3 Policy the patient, and at least one additional on Supervision of Clinical Experience staff member to provide assistance to for Trainees in Anaesthesia, T1 the proceduralist and/or the practitioner Recommendations on Minimum Facilities providing sedation as required. for Safe Administration of Anaesthesia 5.2 The assistant to the practitioner in Operating Suites and Other administering sedation/anaesthesia Anaesthetising Locations). must be exclusively available to the 5.6 In situations other than those when an practitioner at induction of and emergence anaesthetist must be present (noted in from sedation/anaesthesia, and during 4.2 and 5.5), administration of sedation the procedure as required. If general and/or analgesia and monitoring of anaesthesia is intended, and especially in the patient should be performed by emergency situations where endotracheal an appropriately trained medical intubation is planned, a fourth person practitioner other than the proceduralist. to specifically assist the practitioner 5.7 If an appropriately trained medical throughout the procedure is required. practitioner is not present solely to (See College Professional Document administer sedation and/or analgesia PS8 Guidelines on the Assistant to the and monitor the patient, there must be Anaesthetist) an assistant to the proceduralist present 5.3 The practitioner administering procedural during the procedure, who is appropriately sedation and analgesia requires sufficient trained in observation and monitoring of training to be able to: sedated patients, and in resuscitation, 5.3.1 Understand the actions of the and whose sole duty is to monitor the level drugs being administered, and of consciousness and cardiorespiratory be able to modify the technique status of the patient. This person may, appropriately in patients of if appropriately trained, administer sedative different ages, or in the case and/or analgesic drugs under the direct of concurrent drug therapy supervision of the proceduralist, who must or disease processes. have advanced life support skills and 5.3.2 Monitor the patient’s level training (see 5.4). If loss of consciousness, of consciousness and airway obstruction or cardiorespiratory cardiorespiratory status. insufficiency occur at any time, all staff 5.3.3 Detect and manage appropriately must devote their entire attention to any complications arising from monitoring and treating the patient until sedation. recovery, or until such time as another 5.4 A medical practitioner who is skilled in medical practitioner becomes airway management and cardiopulmonary available to take responsibility for the resuscitation must be present whenever patient’s care. procedural sedation and/or analgesia are administered. Endorsed March 2008 6
  7. 7. 6 FACILITIES AND EQUIPMENT 7 TECHNIQUE AND MONITORING The procedure must be performed in a 7.1 Reliable venous access should be in location which is adequate in size, and place for all procedures when procedural staffed and equipped to deal with a sedation and/or analgesia are used. cardiopulmonary emergency. 7.2 As most complications of sedation are This must include: cardiorespiratory, doses of sedative and 6.1 Adequate room to perform resuscitation analgesic drugs should be kept to the should this prove necessary. minimum required for patient comfort, 6.2 Appropriate lighting. particularly for those patients at 6.3 An operating table, trolley or chair increased risk. which can be tilted head down readily. 7.3 Monitoring of the patient’s response 6.4 An adequate suction source, to verbal commands must be routine. catheters and handpiece. Loss of patient response to verbal 6.5 A supply of oxygen and suitable devices commands indicates that loss of for the administration of oxygen to airway reflexes, respiratory and/or a spontaneously breathing patient. cardiovascular depression are likely. 6.6 A means of inflating the lungs with oxygen 7.4 All patients undergoing procedural (e.g. a self-inflating bag) together with a sedation and/or analgesia must be range of equipment for advanced airway monitored continuously with pulse management (e.g. masks, oropharyngeal oximetry and this equipment must airways, laryngeal mask airways, alarm when appropriate limits are laryngoscopes, endotracheal tubes). transgressed. 6.7 Appropriate drugs for cardiopulmonary 7.5 There must be regular recording of pulse resuscitation and a range of intravenous rate, oxygen saturation and blood pressure equipment and fluids (See Appendix II). throughout the procedure in all patients. 6.8 Drugs for reversal of benzodiazepines 7.6 According to the clinical status of the and opioids. patient, other monitors such as ECG 6.9 A pulse oximeter. or capnography may be required 6.10 A sphygmomanometer, or other device (see College Professional Document for measuring blood pressure. PS18 Recommendations on Monitoring 6.11 Ready access to an ECG and a During Anaesthesia). defibrillator. 6.12 A means of summoning emergency 8 OXYGENATION assistance. Hypoxaemia may occur during procedural 6.13 Within the facility there should be access sedation and/or analgesia without oxygen to devices for measuring expired carbon supplementation. Oxygen administration dioxide. (See College Professional diminishes hypoxaemia during procedures Documents T1 Recommendations carried out under sedation /or analgesia, and on Minimum Facilities for Safe must be used in all patients. Pulse oximetry Administration of Anaesthesia in enables the degree of tissue oxygenation to Operating Suites and Other Anaesthetising be monitored and must be used in all patients Locations, PS15 Recommendations for the during procedural sedation and/or analgesia. Perioperative Care of Patients Selected for Day Care Surgery.) Endorsed March 2008 7
  8. 8. 9 MEDICATIONS 11.3 Discharge of the patient should be A variety of drugs and techniques are available authorised by the practitioner who for procedural sedation and/or analgesia. administered the drugs, or another The most common intravenous agents used appropriately qualified practitioner. are benzodiazepines (such as midazolam) The patient should be discharged for sedation and opioids (such as fentanyl) for into the care of a responsible adult analgesia. Even small doses of these drugs to whom written instructions should may result in loss of consciousness in some be given, including advice about eating patients.Special care is required when local and drinking, pain relief, and resumption anaesthesia of the larynx and/or pharynx has of normal activities, as well as about been administered to facilitate the procedure. making legally-binding decisions, Intravenous anaesthetic agents such as driving, or operating machinery. propofol must only be used by a second medical 11.4 A system should be in place to enable practitioner trained in their use, because of safe transfer of the patient to appropriate the risk of unintentional loss of consciousness. medical care should the need arise. These agents must not be administered by the proceduralist. 12 TRAINING IN PROCEDURAL SEDATION AND/OR ANALGESIA10 DOCUMENTATION FOR NON-ANAESTHETIST The clinical record should include the names MEDICAL PRACTITIONERS of staff performing sedation and/or analgesia, It is recommended that non-anaesthetist with documentation of the history, examination medical practitioners wishing to provide and investigation findings. A written record of procedural sedation/analgesia should have the dosages of drugs and the timing of their received a minimum of 3 months full time administration must be kept as a part of the equivalent supervised training in procedural patients records. Such entries should be made sedation and/or analgesia and anaesthesia. as near the time of administration of the drugs as They should participate in a process of possible. This record should also note the regular In-Training and Competency Assessment. readings from the monitored variables, including Training should include completion of a crisis those in the recovery phase, and should contain resource management simulation centre course. other information as indicated in the College It is recognised that there will be non-anaesthetist Professional Document PS6 Recommendations on medical practitioners who have had many years the Recording of an Episode of Anaesthesia Care. experience in procedural sedation and/or analgesia, but who may not have had a period11 RECOVERY AND DISCHARGE of formal supervised training as described. 11.1 Recovery should take place under Such longstanding clinical experience may appropriate supervision in a properly be deemed equivalent to a formal period of equipped and staffed area training as described. Credentialling, training (see College Professional Document and clinical support of such medical practitioners PS4 Recommendations for the should receive close cooperation from nominated Post-Anaesthesia Recovery Room). anaesthetists in the hospital or centre. 11.2 Adequate staffing and facilities must Annual certification in advanced cardiac be available in the recovery area for and life support, and evidence of relevant managing patients who have become Continuing Professional Development, unconscious or who have suffered are required for credentialling. complications during the procedure. Endorsed March 2008 8
  9. 9. 13 REFERENCES The following references provide evidence to support the recommendations made in this document. AGA Institute (Cohen LB et al.). AGA Institute review of endoscopic sedation. Gastroenterology 2007; 133: 675-701 American College of Radiology (Towbin et al.). ACR practice guideline for adult sedation/analgesia. <www.acr.orgSecondaryMainMenuCategories/quality_safety/guidelines/iv/adult_sedation.aspx> 2005 American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists (Gross JB et al.). Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 2002; 96: 1004-1017 American Society of Anesthesiologists. Statement on granting privileges for administration of moderate sedation to practitioners who are non anaesthesia professionals. <> 2006 American Society for Gastrointestinal Endoscopy (Chutkan R et al.). Training guideline for use of propofol in gastrointestinal endoscopy. Gastrointestinal Endoscopy 2004; 60: 167-172 American Society for Gastrointestinal Endoscopy (Vargo JJ et al.). Training in patient monitoring and sedation and analgesia. Gastrointestinal Endoscopy 2007; 66: 7-10 Clarke AC, Chiragakis L, Hillman LC, Kaye GL. Sedation for endoscopy: the safe use of propofol by general practitioner sedationists. Medical Journal of Australia 2002; 176: 159-162 Faigel DO, Pike IM, et al. Quality indicators for gastrointestinal endoscopic procedures: an introduction. Gastrointestinal Endoscopy 2006; 63 (4 Suppl.): S3-S9 Qadeer MA, Vargo JJ, Khandwala F, Lopez R, Zuccaro G. Propofol versus traditional sedative agents for gastrointestinal endoscopy: a meta-analysis. Clinical Gastroenterology & Hepatology 2005; 3: 1049-1056 Rex DK. Review article: moderate sedation for endoscopy: sedation regimens for nonanaesthesiologists. Alimentary Pharmacology & Therapeutics 2006; 24: 163-171 All College Professional Documents must be complied with, but particular note should be taken of the following: PS1 Recommendations on Essential Training for Rural General Practitioners in Australia Proposing to Administer Anaesthesia PS2 Statement on Credentialling in Anaesthesia PS4 Recommendations for the Post-Anaesthesia Recovery Room PS6 The Anaesthesia Record. Recommendations on the Recording of an Episode of Anaesthesia Care PS7 Recommendations on the Pre-Anaesthesia Consultation PS8 Guidelines on the Assistant to the Anaesthetist PS15 Recommendations for the Perioperative Care of Patients Selected for Day Care Surgery PS16 Statement on the Standards of Practice of a Specialist Anaesthetist PS18 Recommendations on Monitoring During Anaesthesia PS26 Guidelines on Consent for Anaesthesia or Sedation T1 Recommendations on Minimum Facilities for Safe Administration of Anaesthesia in Operating Suites and Other Anaesthetising Locations TE3 Policy on Supervision of Clinical Experience for Vocational Trainees in Anaesthesia Endorsed March 2008 9
  10. 10. APPENDIX I APPENDIX IIThe American Society of Anesthesiologists’ Emergency drugs should include at least theclassification of physical status: following:P1 A normal healthy patient • adrenalineP2 A patient with mild systemic disease • atropineP3 A patient with severe systemic disease • dextrose 50%P4 A patient with severe systemic • lignocaine disease that is a constant threat to life • naloxoneP5 A moribund patient who is not expected • flumazenil to survive without the operation • portable emergency O2 supplyP6 A declared brain-dead patient whose organs are being removed for donor purposes E Patient requires emergency procedure Excerpted from American Society of Anesthesiologists Manual for Anesthesia Department Organization and Management 2003-04. A copy of the full text can be obtained from ASA, 520 N Northwest Highway, Park Ridge, Illinois 60068-2573 Endorsed March 2008 10
  11. 11. APPENDIX IIIPersonnel for Procedural Sedation and AnalgesiaScenario 1: Three practitioners – Sedation by Proceduralist • Medical practitioner proceduralist with airway and resuscitation skills, and training in sedation • Practitioner with training in monitoring sedation • Assistant to assist both • Conscious sedation in ASA P 1-2 patients • Propofol, thiopentone and other intravenous anaesthetic agents must not be usedScenario 2: Three practitioners – Sedation by Medical Practitioner • Proceduralist • Medical practitioner with airway and resuscitation skills, and training in sedation • Assistant to assist both • Conscious sedation in ASA P 1-2 patients • Propofol, thiopentone and other intravenous anaesthetic agents may only be used by a medical practitioner trained in their useScenario 3: Four practitioners – Sedation by Medical Practitioner • Proceduralist • Medical practitioner with airway and resuscitation skills, and training in sedation • Assistant to assist each* • Conscious sedation in ASA P 1-3 patients# • Propofol, thiopentone and other intravenous anaesthetic agents may only be used by a medical practitioner trained in their useScenario 4: Three practitioners – Sedation by Anaesthetist • Proceduralist • Anaesthetist • Assistant to assist both • Conscious, deep sedation or general anaesthesia in all patients • All approved anaesthetic drugs may be usedScenario 5: Four practitioners – Sedation by Anaesthetist • Proceduralist • Anaesthetist • Assistant to assist each* • Conscious sedation, deep sedation or general anaesthesia in all patients • All approved anaesthetic drugs may be used* Recommended if assistance is likely to be required for the majority of the case (e.g. complex or emergency patients)# Please refer to Section 4.2 Endorsed March 2008 11
  12. 12. 14 COLLEGE PROFESSIONAL DOCUMENTS College Professional Documents are progressively being coded as follows: TE Training and Educational EX Examinations PS Professional Standards T Technical POLICY - defined as ‘a course of action adopted and pursued by the College’. These are matters coming within the authority and control of the College. RECOMMENDATIONS - defined as ‘advisable courses of action’. GUIDELINES - defined as ‘a document offering advice’. These may be clinical (in which case they will eventually be evidence-based), or nonclinical. STATEMENTS - defined as ‘a communication setting out information’. This document has been prepared having regard to general circumstances, and it is the responsibility of the practitioner to have express regard to the particular circumstances of each case, and the application of this document in each case. Professional documents are reviewed from time to time, and it is the responsibility of the practitioner to ensure that the practitioner has obtained the current version. Professional documents have been prepared having regard to the information available at the time of their preparation, and the practitioner should therefore have regard to any information, research or material which may have been published or become available subsequently. Whilst the College endeavours to ensure that professional documents are as current as possible at the time of their preparation, it takes no responsibility for matters arising from changed circumstances or information or material which may have become available subsequently. PROMULGATED (as P9): 1986 REvIEwED: 1991, 1996, 2001, 2005, 2007 (incorporating PS24 first promulgated in 1992 with reviews in 1997 and 2004) DATE Of CURRENT DOCUMENT: March 2008 © This document is copyright and cannot be reproduced in whole or in part without prior permission. College Website: Endorsed March 2008 12
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