Conscious Sedation: What You Need to Know Michael Sugarman, MD Visiting Professor of Anesthesiology Montefiore Medical Center Albert Einstein College of Medicine

Conscious Sedation 4 Introduction 4 New JCAHO Standards are here! 4 How to... 4 Continuum of Sedation 4 Medications 4 Quality/Risk Management

“Conscious SeaDation”

JCAHO JCAHO (Joint Commission on Accreditation of Healthcare Organizations) directs institutions to develop individual policies, protocols and procedures and provides direction for the content.

JCAHO Standards 4 Pre-procedure Medical Evaluation 4 Informed Consent 4 Credentials of Personnel 4 Qualified Staff Present 4 Necessary Equipment 4 Required Documentation 4 Recovery 4 Quality Management System

JCAHO Scoring of Institutions 4 Has the patient received proper informed consent? 4 Has the patient received a proper pre- procedure medical evaluation? 4 Is moderate or deep sedation provided by qualified individuals? 4 Are sufficient numbers of qualified personnel available to perform the procedure and monitor the patient?

JCAHO Scoring(Continued) 4 Is appropriate equipment available to monitor the patient’s heart rate, respiratory rate, and oxygenation? 4 Is each patient’s status monitored while undergoing moderate or deep sedation and documented in the medical record? 4 Are outcomes of patients undergoing moderate or deep sedation collected and analyzed?

How to... 4 Logistics 4 Patient Evaluation 4 Equipment & Monitoring 4 Managing Complications 4 Recovery

Credentials 4 Procedural sedation must be administered by or under supervision of a credentialed member of the staff 4 Appropriate supporting personnel in attendance. 4 The protocol should describe: 4Training Requirements 4Experience Requirements 4Demonstration of capability in resuscitation and emergency airway management.

Staffing 4 The minimum number of staff required to conduct procedural sedation is two, the operator and a qualified assistant to monitor and provide supportive care of the patient.

Equipment 4 Oxygen 4 Airway rescue equipment 4 Suction 4 Defibrillator 4 Blood pressure 4 EKG 4 Pulse oxymetry

Monitoring  Record at intervals  15 minutes 4Time of day 4Pulse and respiratory rates 4Oxygen saturation 4Level of consciousness 4Dose of each medication administered 4 These will be recorded minimally at pre- and post-procedure.

Patient Evaluation 4Patient interview to review: 4Medical history 4Anesthesia history 4Medication history 4NPO Status 4Appropriate physical examination 4Review of objective diagnostic data (e.g., laboratory, ECG, X-ray) 4Formulation and discussion of a plan with the patient and/or responsible adult

Informed Consent 4 Informed consent is to be obtained by a physician or his/her designee and the record will reflect that the patient was informed of the indications for and accepted the risks associated with procedural sedation 4 The plan of care must be discussed with and approved by an Attending physician.

Recovery and Outcomes 4 Post-procedure and sedation monitoring and evaluation should indicate the elements of decision-making leading to return to routine nursing care, transfer or discharge of each patient. 4 Outcomes should be collected and analyzed for quality of care.

Continuum of Sedation 4 Minimal Sedation (Anxiolysis) 4 Light Sedation/Analgesia (Conscious Sedation) 4 Deep Sedation/Analgesia 4 General Anesthesia

Managing the Continuum 4 Not always possible to predict how an individual will respond 4 Practitioners intending to produce a given level of sedation should be able to rescue patients whose level of sedation becomes deeper than initially intended

Minimal Sedation (Anxiolysis) 4 Drug-induced state 4 Normal response to verbal commands 4 Cognitive function may be impaired 4 Coordination may be impaired 4 Cardiovascular function unaffected 4 Respiratory function unaffected

Moderate Sedation/Analgesia (Conscious Sedation) 4 Drug-induced depression of consciousness 4 Purposeful response to verbal commands 4 Reflex withdrawal from pain persists 4 Impairment of independent ventilatory function 4 Cardiovascular function is usually maintained

Deep Sedation/Analgesia 4 Drug-induced depression of consciousness 4 Difficult to arouse 4 Respond purposefully following repeated or painful stimulation 4 Ability to maintain ventilatory function independently may be compromised 4 Cardiovascular function is usually maintained

General Anesthesia 4 Drug-induced loss of consciousness 4 Cannot be aroused following repeated or painful stimulation 4 Ventilatory function is often impaired with patients often requiring assistance in maintaining a patent airway

General Anesthesia (Continued) 4 Positive pressure ventilation may be necessary because neuromuscular function may be depressed 4 Cardiovascular function may be impaired

Continuum of Depth of Sedation ** reflex withdrawal from a painful stimulus is NOT a purposeful response

Rescue 4 Individuals administering Moderate Sedation/Analgesia should be able to rescue patients who enter a state of Deep Sedation/Analgesia 4 Individuals administering Deep Sedation/Analgesia should be able to rescue patients who enter a state of General Anesthesia

Managing Complications 4 Light Sedation vs. Deep Sedation 4 Hypotension - NPO effects 4 Hypertension 4Anxiety 4Pain  Bladder Distention 4 Cardiac Dysrhythmias

Managing Complications (Continued)  Respiratory Compromise 4Narcotic Induced  Benzodiazepine Induced  Upper Airway Obstruction  Bronchospasm  Laryngospas m 4 Nausea and Vomiting

Recovery 4 Loss of procedural stimulation 4 Oxygen therapy immediately available 4 Urinary Retention 4 Ability to take PO

Discharge Criteria 4 Adequate respiratory function 4 Level of consciousness 4 Intact protective reflexes 4 Vital signs stable 4 Mobility consistent with pre-procedural level 4 Satisfactory skin color and condition/peripheral circulation

Discharge Criteria (Continued) 4 Acceptable nausea/vomiting status 4 Acceptable pain management 4 Stable operative area 4 Understanding by patient and/or significant other of Discharge Instructions

Medications 4 Sedatives 4 Narcotics 4 Reversal Agents

Sedatives

Sedatives (Continued)

Other Sedatives (Induction Agents) 4 Propofol 4Achieve deep sedation quickly 4Apnea occurs frequently 4Rapid passage to general anesthesia 4 Ketamine 4Produces a dissociative state with profound analgesia 4Copious secretions 4Emergence delerium

Narcotics

Narcotics (Continued)

Reversal Agents

Reversal Agents (Continued)

Quality Management 4 Risk Management 4 Quality Management 4Reporting 4Sample Indicators

Risk Management 4 Mechanisms to Reduce Medical Malpractice Related to the Administration of Conscious Sedation 4Education, Preparation & Requirements for the Conscious Sedation Providers 4Quality Management Database 4Data Driven Continuous Quality Improvement

Quality Improvement Monitoring and Reporting 4 The clinical department must regularly reviews 4 Quality indicator thresholds should be specifically established 4 Clear corrective processes should be established when these thresholds have been exceeded 4 Quality Reports will be completed and forwarded to the Quality Office when any of the pre-determined adverse outcome criteria are met

Sample Components of a Conscious Sedation Database 4 ANY use of a Reversal Agent 4 ANY patient requiring Assisted Ventilation (Bag Breathing) 4 ANY new cardiac arrhythmia 4 ANY desaturation of O2 below 90% sustained for 5 minutes

More Sample Components of a Conscious Sedation Database 4 ANY decrease of VS by 30% 4 ANY failure to return to baseline 4 ANY case with unplanned admission resulting from sedation 4 ANY case wherein review is thought to be beneficial