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Joint Trust Guideline for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures For use in: By: For: Division responsible for document: Key words: Name of document author: Job title of document author: Name of document author’s Line Manager: Job title of author’s Line Manager: Supported by: Assessed and approved by the: Date of approval: Ratified by or reported as approved to: To be reviewed before: All areas using intravenous conscious sedation All staff involved in the care of patients receiving intravenous conscious sedation Patients requiring reduction of discomfort during a procedure not requiring general anaesthesia Surgical Division Intravenous Conscious Sedation, Midazolam, Opioids, Flumazenil, Naloxone Dr Nicholas Saunders Consultant Anaesthetist (NNUH) Dr David Spackman Clinical Director, Department of Anaesthetics (NNUH) Dr Dhiraj Ail, Consultant Anaesthetist (JPUH) Clinical Guidelines Assessment Panel (CGAP) If approved by committee or Governance Lead Chair’s Action; tick here 06/10/2016 Clinical Standards Group and Effectiveness Sub-Board This document remains current after this date but will be under review 06/10/2019 To be reviewed by: Reference and / or Trust Docs ID No: Version No: Description of changes: Compliance links: If Yes - does the strategy/policy deviate from the recommendations of NICE? If so why? Dr Nicholas Saunders, Consultant Anaesthetist JCG0004 - 1311 2 Appendix 4 added None N/A This guideline has been approved by the Trust's Clinical Guidelines Assessment Panel as an aid to the diagnosis and management of relevant patients and clinical circumstances. Not every patient or situation fits neatly into a standard guideline scenario and the guideline must be interpreted and applied in practice in the light of prevailing clinical circumstances, the diagnostic and treatment options available and the professional judgement, knowledge and expertise of relevant clinicians. It is advised that the rationale for any departure from relevant guidance should be documented in the patient's case notes. The Trust's guidelines are made publicly available as part of the collective endeavour to continuously improve the quality of healthcare through sharing medical experience and knowledge. The Trust accepts no responsibility for any misunderstanding or misapplication of this document. Joint Trust Clinical Guideline: for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Author/s: Dr Nicholas Saunders Author/s title: Consultant Anaesthetist (NNUH) Approved by: CGAP Date approved: 06/10/2016 Review date: 06/10/2019 Available via Trust Docs Version: 2 Trust Docs ID: JCG004 - 1311 Page 1 of 11 Joint Trust Guideline for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Joint Trust Clinical Guideline: for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Author/s: Dr Nicholas Saunders Author/s title: Consultant Anaesthetist (NNUH) Approved by: CGAP Date approved: 06/10/2016 Review date: 06/10/2019 Available via Trust Docs Version: 2 Trust Docs ID: JCG004 - 1311 Page 2 of 11 Joint Trust Guideline for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Quick reference Guideline All departments using IV conscious sedation should have a named lead clinician responsible for the use of IV sedation and a departmental protocol. All staff involved in the administration of IV drugs for conscious sedation and patient care should have recent and current resuscitation training and also have training in conscious sedation. All patients should have a comprehensive pre procedural assessment of their medical history and medication. Vital signs should be recorded. Consent for conscious sedation should be taken. Procedures should only take place in areas prepared for sedation, eg endoscopy, A&E, radiology and theatres. All areas should be equipped with oxygen, resuscitation equipment and full monitoring. Capnography is not mandatory for conscious sedation but is desirable and should be considered a developmental standard 10. A trained staff member should be responsible for monitoring the patient during the procedures. Records should be made including pre procedural information and vital signs, and observations during the procedure. Benzodiazepines and opioids depress the central nervous system and have the potential to impair respiration or circulation or both. Extra care should be taken when sedating the elderly and frail, or combining an opioid with a benzodiazepine. Antagonist should be available and practitioners should be trained in administration. (Appendix 2) Patients should be monitored in a recovery area with a fully trained nurse until discharge criteria met. (Appendix 4) Patients must be accompanied by a competent adult for the next 24 hours. They should be given comprehensive post sedation instructions. Drug dosage, use of antagonists and adverse events should be an integral part of the written record and audited regularly. Objective These guidelines are designed to guide the safe use of intravenous (IV) conscious sedation used to reduce discomfort and anxiety of a procedure not requiring a general anaesthetic (including sedation in theatres but not using an anaesthetist). Rationale Sedation is used to make uncomfortable and painful procedures more acceptable to patients but has the potential to cause life threatening complications. The National Patient Safety Agency (NPSA) rapid response alert 1 highlighted that the use of midazolam for conscious sedation has been responsible for 3 deaths, and the 2004 Joint Trust Clinical Guideline: for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Author/s: Dr Nicholas Saunders Author/s title: Consultant Anaesthetist (NNUH) Approved by: CGAP Date approved: 06/10/2016 Review date: 06/10/2019 Available via Trust Docs Version: 2 Trust Docs ID: JCG004 - 1311 Page 3 of 11 Joint Trust Guideline for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures National Confidential Enquiry into Patient Outcome and Death (NCEPOD) report 2 showed that elderly patients are particularly vulnerable. Broad Recommendations Definition of Conscious Sedation A technique in which the use of drug or drugs produces a state of depression of the central nervous system enabling treatment to be carried out, but during which verbal contact with the patient is maintained throughout the period of sedation. The drug and techniques used to provide conscious sedation should carry a margin of safety wide enough to render loss of consciousness unlikely. Deeper levels of sedation, where verbal contact is lost, have the potential to cardiovascular and or respiratory depression as well as loss of airway reflexes. This may result in significant morbidity and mortality 9 Drugs preferred for sedation The preferred drugs to be used for sedation are midazolam and fentanyl. These are both short acting drugs with an onset of 1-2 minutes and a peak effect of 3-5 minutes. The analgesic effects of fentanyl last about 30-60 minutes therefore occasionally morphine is needed for a more prolonged analgesic effect after the procedure. Morphine has a longer onset with a peak intravenous effect of 20 minutes, therefore the patients should be observed for at least 10-15 minutes before the midazolam is administered. See appendix 2 for further information about dosing, side effects and cautions. Propofol should not be used by non-anaesthetists for sedation. Staff training All departments using IV conscious sedation should have a named lead clinician responsible for the use of IV sedation and a departmental protocol including the points covered in this general guideline specific to their department and the procedures it is being use for. The doctors supervising conscious sedation should be up to date with current ALS protocols and regularly attend mandatory resuscitation training. All other staff involved in the administration of IV drugs for conscious sedation, including operator and observer, should have recent and current resuscitation training e.g. Intermediate Life Support training. They should also have training in the administration and actions of the drugs being used and be able to recognise and deal with the complications of administration. Training can be either completion of a course on conscious sedation, such as is provided by NANIME for the dentists, or similar external course and/or a suitable period of training with an experienced sedationist until considered competent. Pre procedural assessment Joint Trust Clinical Guideline: for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Author/s: Dr Nicholas Saunders Author/s title: Consultant Anaesthetist (NNUH) Approved by: CGAP Date approved: 06/10/2016 Review date: 06/10/2019 Available via Trust Docs Version: 2 Trust Docs ID: JCG004 - 1311 Page 4 of 11 Trust Guideline for the Management of Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures All patients should have an assessment covering previous medical history, drug history, allergies, smoking and alcohol history, previous anaesthetic history including complications. Baseline vital signs including heart rate, blood pressure, oxygen saturation, weight. Consent for sedation and procedure should be taken. American Society of Anesthesiologists (ASA) grade should be noted (see Appendix 1). Procedures carried out on elderly patients who may have significant co-morbidity and even in younger patients. The presence of heart disease, cerebrovascular disease, insulin dependant diabetes, lung disease, liver failure, anaemia, shock and morbid obesity are risk factors. The possible effect of any concurrent medication should be assessed as to its possible effects on the sedation process. 4 Consent for conscious sedation and the procedure should be taken at this time and information should be given on oral intake and post procedural requirements. Equipment Equipment should be available in both procedural areas and recovery areas. This should include full monitoring equipment including ECG, Blood pressure, oxygen saturation monitoring; resuscitation equipment including defibrillator and resuscitation drugs; oxygen and oxygen delivery systems; suction; a tipping trolley; intravenous access devices and fluids. The use of continuous capnography is recommended wherever conscious sedation is planned. Management of sedation A period of starvation of 6 hours for food and 2 hours for clear fluids would reduce the risk of aspiration should over-sedation occur. In the case of upper gastrointestinal haemorrhage, light sedation is preferable to pharyngeal local anaesthesia which can lead to loss of gag reflex. The drugs used for IV conscious sedation are benzodiazepines and opioids. These drugs depress the central nervous system and have the potential to impair respiration or circulation or both, particularly in the presence of disease or old age.3 When used together there is a synergistic effect which can increase the risk of cardiorespiratory events. Dosage of benzodiazepines and opiates should be kept to a minimum to achieve sedation and should be within the manufacturer’s guidelines. 4 If a combination of drugs is considered necessary the opioids should, whenever possible, be given before benzodiazepines and their effect observed before proceeding 4 to give any sedative. Each drug should be flushed with sterile 0.9% sodium chloride after each administration. Verbal contact should be kept with the patient at all times. In patients over 70 years no more than 2 mg of midazolam should be drawn up into a syringe. In most instances the maximum dose should be 2 mg of midazolam, but it may be necessary to exceed this dose.2 Further doses should be kept to small increments. Reversal agents should be available at all times and staff should know how and when to administer the drugs and recognise the complications. (Appendix 2) Joint Trust Clinical Guideline: for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Author/s: Dr Nicholas Saunders Author/s title: Consultant Anaesthetist (NNUH) Approved by: CGAP Date approved: 06/10/2016 Review date: 06/10/2019 Available via Trust Docs Version: 2 Trust Docs ID: JCG004 - 1311 Page 5 of 11 Joint Trust Guideline for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures The use of oxygen via face mask or nasal prongs during sedation will reduce the risk of hypoxia.5 A suitably trained member of staff should be responsible for monitoring the patient throughout the procedure. Level of sedation, oxygen saturations (SpO 2) and blood pressure should be recorded at regular intervals. ECG monitoring should be added for patients with cardiac risk factors.5 Recovery and Post Procedure Monitoring The patients should be recovered in a dedicated recovery area, equipped with resuscitation equipment, full monitoring and oxygen. There should be a fully trained member of staff in attendance at all times and monitoring should be continued until the level of consciousness and other vital signs have returned to pre-procedural baseline levels. The patients should be discharged into the care of a competent adult and should not drive, operate machinery or sign legal documents for the next 24 hours. Patients should be given written instructions about common after effects of their procedure and sedation. A contact number should be provided in case of any problems. Clinical audit standards Audit should be an integral part of the written record of sedation. Drug dosage, use of antagonists and adverse events should be audited regularly. Summary of development and registration and dissemination consultation process undertaken before The authors listed above reviewed this guideline on behalf of the Anaesthetic department who has agreed the final content. This version has been endorsed by the Clinical Guidelines Assessment Panel. Distribution list/ dissemination method All A&E staff, Radiology staff, Endoscopy staff, Theatre staff and Dental staff. Available on the Trust Intranet. References/ source documents 1. Reducing risk of overdose with midazolam injection in adults. Rapid Response report. NPSA/2008/RRR011 2. Elderly patient vulnerable to sedative overdose. Gray A, Bell GD. National Patient Safety Agency. Patient Safety Bulletin: Number 3, January 2007. www.npsa.nhs.uk/patientsafety/patient-safety-incident-data/bulletins-andnewsletters/archive Accessed 4 April 2009 3. Implementing and ensuring Safe Sedation Practice for Healthcare Procedures in adults. Report of an Intercollegiate Working Party chaired by the Royal College of Anaesthetists, November 2001 http://www.rcoa.ac.uk/docs/safesedationpractice.pdf Accessed 25 March 2009 4. Safety and sedation during endoscopic procedures. British Society of Gastroenterology. September 2003 www.bsg.org.uk Joint Trust Clinical Guideline: for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Author/s: Dr Nicholas Saunders Author/s title: Consultant Anaesthetist (NNUH) Approved by: CGAP Date approved: 06/10/2016 Review date: 06/10/2019 Available via Trust Docs Version: 2 Trust Docs ID: JCG004 - 1311 Page 6 of 11 Trust Guideline for the Management of Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures http://www.bsg.org.uk/images/stories/docs/clinical/guidelines/endoscopy/sedation .doc Accessed 04 April 2009 5. Local Anaesthesia and Sedation: managing the risk. May 2007 Published by Association for Perioperative Practice. 6. British National Formulary. Available at http://bnf.org/bnf/ Accessed 26 August 2009 7. Safe sedation of adults in the emergency department. RCoA and CEM, London 2012 (www.rcoa.ac.uk/node/10214). 8. The use of capnography outside the operating theatre. Updated statement from the Association of Anaesthetists of Great Britain and Northern Irelend (AAGBI). May 2011 9. General Provision of Anaesthetic Practice (GPAS 2015). www.rcoa.ac.uk/gpas2015 10. Practice for Healthcare Procedures: Standards and Guidance. AoMRC, London 2013 (www.rcoa.ac.uk/node/15182). Joint Trust Clinical Guideline: for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Author/s: Dr Nicholas Saunders Author/s title: Consultant Anaesthetist (NNUH) Approved by: CGAP Date approved: 06/10/2016 Review date: 06/10/2019 Available via Trust Docs Version: 2 Trust Docs ID: JCG004 - 1311 Page 7 of 11 Joint Trust Guideline for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Appendix 1 ASA grade ASA Grade Description 1 Normal healthy individual 2 Mild systemic disease that does not limit activity 3 4 5 Severe systemic disease that limits activity but is not incapacitating Incapacitating systemic disease which is constantly life threatening Moribund, not expected to survive 24 hours with or without surgery Appendix 2 Joint Trust Clinical Guideline: for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Author/s: Dr Nicholas Saunders Author/s title: Consultant Anaesthetist (NNUH) Approved by: CGAP Date approved: 06/10/2016 Review date: 06/10/2019 Available via Trust Docs Version: 2 Trust Docs ID: JCG004 - 1311 Page 8 of 11 Trust Guideline for the Management of Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Table of Preferred Drugs - list including safe dosages Sedative Dose Midazolam Healthy adult: 12mg bolus. Titrate further small boluses with at least 2 minutes between doses. Usually max 5mg required. Elderly or unwell: 0.5-1mg bolus. Titrate further small boluses with at least 2 minutes between doses. Often no more than 2 mg required. Fentanyl 50mcg initial bolus then incremental boluses of 2550mcg to a maximum of 100mcg. Reduce dose in elderly or debilitated. Morphine 0.05mg-0.1mg initial intravenous bolus then observe for minimum 1015min before addition of benzodiazepine. Reduce dose in elderly Onset 3-5 minutes for peak effect. Half life 1.5-3.5 hours. Side effects CARDIORESPIRATORY DEPRESSION especially associated with opioids. Gastro-intestinal disturbances, anaphylaxis, drowsiness, confusion, ataxia, amnesia, headache, paradoxical excitement and aggression (especially in children and elderly), dysarthria; injection-site reactions. For complete list see BNF Cautions Cardiac disease; hepatic impairment; renal impairment; (increases plasma half life x2-2.5) respiratory disease; myasthenia gravis; history of drug or alcohol abuse; risk of severe hypotension in hypovolaemia, vasoconstriction, hypothermia; pregnancy and breast-feeding Onset 1-2 minutes, peal effect 3-5 minutes. Lasts 3060 mins General opioid side effects. Nausea and vomiting (less with fentanyl), constipation, dry mouth; larger doses produce muscle rigidity, hypotension, and respiratory depression. Other common side-effects include bradycardia, tachycardia, palpitations, postural hypotension, euphoria, dysphoria, dizziness, confusion, drowsiness, flushing, rash, urticaria, and pruritus. See BNF for complete list Impaired respiratory function (avoid in chronic obstructive pulmonary disease) and asthma (acute attack), hypotension, shock, myasthenia gravis. Reduced dose is recommended in hepatic impairment and renal impairment, in hypothyroidism, and in adrenocortical insufficiency. Pregnancy and breast-feeding Onset 1015 mins, peak effect at 20mins. Half life 1.7-4.5 hours. Joint Trust Clinical Guideline: for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Author/s: Dr Nicholas Saunders Author/s title: Consultant Anaesthetist (NNUH) Approved by: CGAP Date approved: 06/10/2016 Review date: 06/10/2019 Available via Trust Docs Version: 2 Trust Docs ID: JCG004 - 1311 Page 9 of 11 Joint Trust Guideline for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Appendix 36 Treatment of over sedation Sedative Antagonist Dose drug Midazolam Flumazenil O.2mg IV boluses up to max 1mg Infusion may be required. Onset Side effects Cautions 1-2 minutes, peak 6-10 minutes. Lasts 15140min Short acting, benzodiazepi ne dependence (seizures), prolonged treatment of convulsions (seizures), head injury, elderly, children, hepatic impairment, pregnancy, breast feeding. Opioid 2 minutes. Lasts 20 minutes Nausea, vomiting, and flushing; agitation, anxiety, and fear; transient increase in blood pressure and heart-rate; very rarely convulsions (particularly in those with epilepsy), hypersensitivit y reactions including anaphylaxis. Hypotension, hypertension, ventricular tachycardia or fibrillation, cardiac arrest, hyperventilatio n, dypnoea, pulmonary hypertension, agitation. Naloxone 0.1mg-0.2mg IV boluses. Repeat doses at 23min. 0.42mg can be used if required up to max 10mg. Infusion may be required. Cardiovascul ar disease or cardiotoxic drugs, physical dependence on opioids – acute withdrawal, short acting, pregnancy. Joint Trust Clinical Guideline: for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Author/s: Dr Nicholas Saunders Author/s title: Consultant Anaesthetist (NNUH) Approved by: CGAP Date approved: 06/10/2016 Review date: 06/10/2019 Available via Trust Docs Version: 2 Trust Docs ID: JCG004 - 1311 Page 10 of 11 Trust Guideline for the Management of Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Appendix 47 Criteria for discharge The patient has returned to their baseline level of consciousness Vital signs are within normal limits for that patient Respiratory status is not compromised Pain and discomfort have been addressed Joint Trust Clinical Guideline: for the Safe use of Intravenous Conscious Sedation in Adult Patients undergoing Procedures Author/s: Dr Nicholas Saunders Author/s title: Consultant Anaesthetist (NNUH) Approved by: CGAP Date approved: 06/10/2016 Review date: 06/10/2019 Available via Trust Docs Version: 2 Trust Docs ID: JCG004 - 1311 Page 11 of 11