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1 Policy Procedural Sedation and Analgesia Page 1 of 10 Scope: Providers and nurses (M.D., D.O., D.M.D., D.D.S., A.P.R.N., P.A., R.N.) with appropriate privileges and who have successfully demonstrated adequate knowledge, skills, and competency in the administration and monitoring of procedural sedation and analgesia. Qualifications for administering procedural sedation/analgesia are listed in Appendix I. Definitions: Because levels of sedation are a continuum, it is not always possible to predict how an individual patient receiving medication with the intent to achieve sedation/analgesia for a procedure will respond. Definitions of the four levels of sedation and anesthesia include the following. Minimal sedation (anxiolysis) is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected. Moderate sedation/analgesia is a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway. Spontaneous ventilation is adequate. Cardiovascular function is maintained. No additional cardio-respiratory support is required. Deep sedation/analgesia is a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway. Spontaneous ventilation may become inadequate. Cardiovascular function may be affected. General Anesthesia is a state of drug-induced depression of consciousness during which patients do not respond to stimulation, including painful stimulation, and consists of inhalation, IM, IV, spinal or major regional anesthesia. It does not include local anesthesia. The ability to spontaneously maintain ventilatory function is impaired and patients often

2 Page 2 of 10 require assistance in maintaining a patent airway. Positive pressure ventilation may be required because of decreased spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. Rescue Capacity: Personnel providing procedural sedation must ensure that procedures are in place to rescue patients whose level of sedation becomes deeper than initially intended. Rescue from a deeper level of sedation may require interventions by a practitioner skilled in airway management and resuscitation to correct adverse physiologic consequences of the deeper-than-intended level of sedation and return the patient to the originally intended level of sedation. Policy: This policy establishes a uniform level of care and defines the parameters to be followed for the administration and recovery of patients receiving procedural sedation/analgesia at Hartford Hospital. This policy allows clinicians to provide their patients with the benefits of procedural sedation and analgesia while minimizing the associated risks. Procedural sedation/analgesia allows patients to tolerate unpleasant procedures by relieving anxiety and discomfort. In children and uncooperative adults, sedation/analgesia may expedite the conduct of procedures where the patient s movements must be controlled or minimized. Excessive sedation/analgesia may result in cardiac or respiratory depression, which must be rapidly recognized and appropriately managed to avoid the risk of hypoxic brain damage, cardiac arrest or death. Conversely, inadequate sedation/analgesia may result in undue patient discomfort or actual patient injury because of lack of cooperation or adverse physiological response to stress. This policy applies to clinical situations in which patients receive moderate sedation, deep sedation, or general anesthesia for procedures outside of the operating room, in any setting, by any route, in any inpatient, outpatient, ambulatory care or emergency department area of the Hartford Hospital campus. Department-specific guidelines for procedural sedation/analgesia do not invalidate nor revoke this general hospital-wide policy.

3 Page 3 of 10 Staffing A minimum of one additional person certified in Advanced Cardiac Life Support (ACLS) or departmental equivalent, should be available in close proximity during all procedures to assist in resuscitative efforts if necessary. For procedures requiring deep sedation, the physician administering medications and monitoring the patient cannot be the same physician performing the procedure. Documentation The following documentation must be completed. 1. Pre-procedural documentation should include: a. History and physical: i.baseline vital signs ii.airway assessment iii.physical status classification iv. Modified Aldrete Score (or equivalent) b. Co-existing disease processes c. Laboratory evaluation as indicated d. Intravenous access (catheter gauge and location) e. NPO status (Appendix III) 2. Intra-procedural documentation: a. Vital signs including blood pressure, heart rate, heart rhythm, respiratory rate, end-tidal carbon dioxide when used, oxygen saturation, and level of consciousness (RASS) are to be documented every five (5) minutes during the procedure. b. Fluids/Estimated Blood loss c. Oxygen administration 3. Post-procedural Documentation: a. Vital signs including blood pressure, oxygen saturation, heart rate, level of consciousness, and heart rhythm should be documented every fifteen (15) minutes until the patient meets discharge criteria or returns to baseline (if not being discharged) b. Documentation of additional medications if necessary. c. Complications including but not limited to nausea, vomiting, hypotension, respiratory depression, hypertension. d. Supplemental oxygen use e. Documentation of pain score f. The following post-procedural instructions for outpatient procedures should be provided to caregiver: i.primary or follow-up physician s contact number.

4 Page 4 of 10 ii.level of activity permitted (such as not operating a motor vehicle, heavy machinery, or signing legal documents). iii.course of action if complications should develop. iv.follow-up care Discharge Criteria A physician qualified to administer procedural sedation/analgesia is responsible for discharge from the recovery unit. Criteria for discharge should be based upon the Modified Aldrete Scale (or equivalent). Sufficient time (two hours) should elapse after last administration of reversal agents. Outpatients should be discharged to a responsible adult who will accompany the patient to their place of residence whenever possible. This individual should receive post-procedural instructions and report any complications. Quality Assessment Performance Improvement and Adverse Event Reporting Sedation services policies and procedures will undergo periodic re-evaluation that includes analysis of medication errors and adverse events; ensure satisfactory documentation and compliance with protocols; and identify opportunities for improvement. The provider involved in the administration of procedural sedation/analgesia is responsible for reporting adverse events in a timely manner. This information will remain confidential in order to encourage participation in the quality improvement program. Each service involved in procedural sedation/analgesia will participate in a departmental and/or institution-wide multidisciplinary quality assurance program. Key Words Search: Sedation, Moderate Sedation, Deep Sedation, Anesthesia, Procedural Sedation. Issued: May 5, 2014 Proponent: Witold Waberski, MD Replaces: Monitoring Support of Patients Receiving Moderate Sedation and Analgesia During Diagnostic, Therapeutic Procedures Policy Dated Revised Oct 2006, Review Nov 2011 Approved by: CPC Policy & Procedure Subgroup 2/2014 Reviewed: Revised:

5 Page 5 of 10 Appendix I A. Qualifications of Practitioners Administering Moderate Sedation/Analgesia Practitioners utilizing moderate sedation/analgesia techniques for procedures must be credentialed through the Medical Staff Office and their respective Clinical Department. In order for practitioners to administer moderate procedural sedation/analgesia, the practitioner must have current privileges and demonstrate competency through successful completion of the Hospital s web based exam reviewing pharmacokinetics, pharmacodynamics, indications, contraindications, doses, complications, and treatment of adverse reactions of drugs used for procedural sedation/analgesia. Licensed Practitioner's who order, administer, or monitor moderate sedation/analgesia will have and maintain current practice appropriate ACLS (Advanced Cardiac Life Support), ATLS (Adult Trauma Life Support), PALS (Pediatric Advanced Life Support), or NRP (Neonatal Resuscitation Program} certification or equivalent Departmental validation, prior to performing moderate sedation. Senior residents who utilize moderate sedation techniques must do so within their individual scope of practice, and under supervision of a physician with moderate sedation privileges. The Registered Nursing staff who administer and/or monitor sedated patients will complete Moderate Sedation/Analgesia Competency prior to performing moderate sedation duties and at least annually thereafter. In-service education and competency records will be maintained. B. Qualifications for Physicians Administering Deep Sedation/General Anesthesia 1. Must have all Qualifications for Practitioners Administering Moderate Sedation/Analgesia plus 2. Must be Board Certified in a physician specialty whose national organization has established guidelines for deep sedation/general anesthesia. These include but are not limited to: Anesthesiology, Emergency Medicine, Oral MaxilloFacial Surgery, and Dentistry.

6 Page 6 of 10 Appendix II Facility Requirement (Equipment and Monitoring) 1. Age appropriate emergency equipment and drugs should be available whenever procedural sedation/analgesia is administered as outlined below. 2. Appropriate monitors for procedural sedation/analgesia must include pulse oximetry, electrocardiogram and blood pressure monitoring. Capnograph can be used when procedure allows. Temperature monitoring should be considered for pediatric patients and for procedures longer than one hour. 3. Intravenous access should be established in all patients receiving procedural sedation/analgesia regardless of the route of drug administration. 4. Availability of Basic Airway management equipment: a. Oxygen source (pipeline or tank with regulator), b. Face mask or nasal cannula c. Oral and nasal airways d. Positive pressure ventilation device (self-inflating breathing bag valve set) e. Suction source and catheters f. End-tidal carbon dioxide detector 5. Advanced Airway Equipment should be immediately available: a. Laryngeal mask airways b. Age appropriate laryngoscope and endotracheal tubes c. Stylet appropriately sized for endotracheal tubes 6. Emergency Equipment: a. Defibrillator should be immediately available b. Emergency drugs including pharmacological antagonists 7. Post -Procedural Recovery Area: a. Nurse to Patient ratio should not exceed 1:2 b. Monitors including electrocardiogram, pulse oximeter, non-invasive blood pressure and if indicated, temperature c. Oxygen source and suction must be available d. Basic airway equipment must be immediately available

7 Page 7 of 10 Appendix III Pre - Procedure Fasting Guidelines These recommendations apply to health ASA I and ASA II patients undergoing elective procedures. These guidelines do not guarantee complete gastric emptying. Ingested Material Minimal Fasting Period Clear liquids* Breast milk Infant formula Non-human milk Light meal (toast, clear liquids) 2 hours 4 hours 6 hours 6 hours 6-8 hours * Clear liquids include water, clear juices without pulp, clear carbonated beverages, black tea or coffee Appendix IV Procedural Sedation Continuum See Chart below: pages 8-10

8 Page 8 of 10 ASA SEDATION & CONTINUUM MILD ANXIOLYSIS MODERATE SEDATION & DEEP SEDATION & ANESTHESIA Intention (responsiveness) Determined by the Proceduralist Anticipated Outcomes (Airway, Cardiovascular) Examples The same procedure may require higher or lower levels of sedation depending on the individual patient. The level is to be determined by the proceduralist. Responds normally to commands GOAL: RASS (or equivalent LOC scale) score = 0 Airway maintained CV support not needed 1 mg ativan po before MRI Responds purposefully to verbal commands/or light touch GOAL: RASS (or equivalent LOC scale) score greater than - 4 Airway maintained CV support not needed Combination of opiates & benzos, typically Procedure examples may include: Bronchoscopy Cardiac Cath Colonoscopy Chest tube insertion Dressing change Endoscopy Line placement Responds to pain Reflex withdrawal GOAL: RASS (or equivalent LOC scale) score - 4 Airway may require support CV support may be needed Higher doses of opiates & benzos and/or anesthetic agents as needed to induce response only to painful stimuli Procedure examples may include: Bronchoscopy Cardiac Cath Colonoscopy Dressing change Endoscopy PEG placement No response GOAL: RASS (or equivalent LOC scale) score - 5 Airway requires support CV support may be necessary Induction doses of anesthetic agents:100 mg propofol & other anesthetic agents Procedure examples may include, surgical procedures done at bedside such as: Trachs/Perc trachs PEG placement

9 Page 9 of 10 ASA SEDATION & CONTINUUM MILD ANXIOLYSIS MODERATE SEDATION & DEEP SEDATION & ANESTHESIA Who can administer Who must be at the bedside Equipment at bedside None RN RN validated in moderate sedation or MD validated in Moderate Sedation RN A minimum of 2 clinicians: 1. Proceduralist 2. RN validated in Moderate Sedation to monitor and document. The RN must be CPR certified and able to establish an airway if needed (by positioning, (Emergency equipment must be available) OPA, BVM) Oxygen (on during procedure) BVM available Pulse ox (on) BP device (on) Cardiac monitor (on) Suction Emergency cart Reversal agents ET CO2 if indicated Anesthesiologist, ED Attending or other credentialed provider A minimum of 3 clinicians: 1. Proceduralist 2. Anesthesiologist or credentialed MD (ED attending and others) to administer medications and monitor 3. RN to assist with procedure Oxygen or Ventilator with appropriate settings BVM at bedside Pulse ox (on) BP device (on) Cardiac monitor (on) Suction Emergency cart Reversal agents ET CO2 if indicated Anesthesiologist, ED Attending or other credentialed provider A minimum of 3 clinicians: 1. Proceduralist 2. Anesthesiologist or credentialed MD (ED attending and others) to administer medications and monitor 3. RN to assist with procedure Oxygen or Ventilator with appropriate settings BVM at bedside Pulse ox (on) BP device (on) Cardiac monitor (on) Suction Emergency cart Reversal agents ET CO2

10 Page 10 of 10 ASA SEDATION & CONTINUUM MILD ANXIOLYSIS MODERATE SEDATION & DEEP SEDATION & ANESTHESIA Intra-Procedure Monitoring None Q 5-10 min LOC (RASS or equivalent), rhythm,vs, O2 sat, ETCO2 if indicated Aldrete score pre-procedure. Monitoring and documentation by provider administering sedation or general anesthesia Monitoring and documentation by provider administering sedation or general anesthesia Recovery Monitoring None By RN validated in Moderate Sedation Q 15 min LOC (RASS or equivalent), rhythm, VS, O2 sat Aldrete Score Q 15 min until returned to baseline By ICU or PACU nurse with competency in Anesthesia Recovery or by Anesthesiologist By ICU or PACU nurse with competency in Anesthesia Recovery or by Anesthesiologist By RN validated in Moderate Sedation Documentation emar Moderate Sedation Flowsheet HH Form Authored by L. Meisterling, A. Russell, W. Waberski RN will document medications administered in emar Provider will monitor & document up to recovery. RN will indicate on flowsheet that VS are on another sheet. Anesthesia service will monitor & document on Anesthesia Flowsheet up through recovery. RN will indicate on flowsheet that VS are on another sheet.

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