Title/Description: Department: Personnel: Effective Date: Revised: PURPOSE DEFINITIONS

Transcription

1 Title/Description: Moderate Sedation and Anesthesia Care Department: Organization-wide Personnel: All Individuals Involved in Anesthesia Care Effective Date: 9/90 Revised: 3/94, 12/96, 4/00, 11/02, 02/03, 6/03, 12/04, 5/05, 1/06, 7/08, 3/12, 7/12, 12/14 PURPOSE To provide safe and consistent care for patients receiving sedation, whether moderate or deep, during therapeutic or diagnostic procedures, this would be in any setting, for any purpose, by any route, for minimal or moderate sedation. These guidelines are designed to provide specific recommendations for the safe care of patients during the delivery of medications for sedation by non-anesthesiologists during diagnostic and therapeutic procedures. Procedural Sedation (deep) may be performed with or without analgesia at the discretion of the Practitioner. DEFINITIONS 1. MINIMAL SEDATION (anxiolysis)- 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. 2. MODERATE SEDATION/ANALGESIA ( conscious sedation )- 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, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. 3. DEEP SEDATION/analgesia- 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 and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. 4. ANESTHESIA- Consists of general anesthesia and spinal or major regional anesthesia. It does not include local anesthesia. General anesthesia is a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. 5. PROCEDURAL SEDATION-The administration of pharmacological agents to produce a sedated or dissociated state where the patient s lack of response and altered

2 cognition will aid in the performance of an unpleasant or painful procedure. Procedural Sedation and Analgesia is intended to result in a depressed level of consciousness but one that allows the patient to maintain airway control independently and continuously. The drugs, doses and techniques used are not likely to produce a loss of protective airway reflexes. 6. DISSOCIATIVE SEDATION-A trance-like cataleptic state induced by the dissociative agent ketamine and characterized by profound analgesia and amnesia, with retention of protective airway reflexes, spontaneous respirations, and cardiopulmonary stability. 7. LOSS OF PROTECTIVE REFLEXES-Loss of reflexes, including the inability to maintain a patent airway, handle secretions without aspiration or purposeful response to physical and/or verbal stimulation as a result of a systemically administered medication. 8. PRACTITIONER-Within the context of this policy, refers to a physician who is appropriately credentialed to provide Procedural Sedation. PROCEDURE I. Physician Responsibilities (credentials in sedation and anesthesia care) 1. Trained in professional standards & techniques to: a) Administer pharmacologic agents to predictably achieve desired levels of sedation; and b) Monitor patients carefully in order to maintain them at the desired level of sedation. c) Appropriate credentials to manage patients at whatever level of sedation or anesthesia achieved, either intentionally or unintentionally. d) Competency-based education, training & experience in evaluating patients prior to performing moderate or deep sedation & anesthesia and to include methods & techniques required to rescue those patients who unavoidably or unintentionally slip into a deeper-than desired level of sedation or analgesia including: - Practitioners who have appropriate credentials and are permitted to administer moderate sedation, are qualified to rescue patients from deep sedation and are competent to manage a compromised airway and to provide adequate oxygenation and ventilation. - Practitioners who have appropriate credentials and are permitted to administer deep sedation for procedures such as: dislocations & rapid intubation etc. are qualified to rescue patients from general anesthesia and are competent to manage an unstable cardiovascular system as well as a compromised airway and inadequate oxygenation and ventilation. - Qualified personnel are present during procedures using moderate or deep sedation to : * appropriately evaluate the patient prior to beginning moderate or

3 deep sedation and anesthesia; * provide the moderate or deep sedation and anesthesia; * perform the procedure; * monitor the patient; and * recover and discharge the patient either from the postsedation or postanesthesia recovery area 2. Physician will obtain informed consent in the discussion with the patient concerning Procedural Sedation, and make the determination of the eligibility of the patient for procedural sedation. The discretion of the physician is used on a patient by patient basis. Risks vs. benefits and complications will also be addressed by the M.D. II. Educational Requirements A. The following personnel are authorized to administer agents for moderate sedation: 1. Physicians or other licensed health care professionals who have appropriate credentials to administer sedation agents. This will be done by successful completion of appropriate training which should include residency training and/or continuing medical education in the following subject areas: a. IV Therapy b. Oxygen Delivery Devices c. Airway Management both basic and advanced d. Pharmacology of Sedation agents, and their antagonist including drug administration techniques, characteristics, and management of adverse reactions and over dosage, and other complications. e. Dysrhythmia recognition f. Basic Cardiac Life Support g. Organized program of study on moderate sedation 2. Anesthesiologists and CRNA s appropriately credentialed to administer sedation. 3. The practitioner s continued competency to provide Procedural Sedation will be re-evaluated as part of the Medical Staff recredentialing process. III. Locations where sedation may be administered 1. OR / PACU / OPS/GI Lab 2. ICU/ Radiology, including CT & MRI Special Procedures 4. Cardiac Catherization Lab 5. Emergency Department

4 6. Bronchoscopy Lab Note: Monitoring and credentialing requirements must be met regardless of the location of such procedures. IV. Documentation All departments will use the Moderate Sedation documentation found in Sunrise under Flow Sheets and also under Document Tab in Sunrise under Nursing IntraOp and including the following: 1. Listing of current medications and dosages 2. Drug allergies, history of tobacco, alcohol, or substance abuse, drug reactions 3. Pregnancy status is noted, if applicable 4. Time and nature of last oral intake-recent food intake is not a contraindication for administering Procedural Sedation but should be considered in choosing the depth and target level of sedation. 5. Overall physical status according to the American Society of Anesthesiologists (ASA) ASA Class 1: A normal, healthy patient ASA Class 2: A patient with mild systemic disease (ex: Asthma, controlled diabetes) ASA Class 3: A patient with severe systemic disease (ex: moderate COPD, stable angina) ASA Class 4: A patient with severe systemic disease that is a constant threat to life (ex: unstable angina, DKA) ASA Class 5: A Moribund patient who is not expected to survive without the operation. ASA Class 6: A declared brain dead person whose organs are being removed for donor purposes: 6. Procedural Sedation for patients- falling into classes III, IV, V, or VI is generally not recommended. Should Procedural Sedation be deemed necessary by the attending physician for this class of patient, it should be performed in consultation with the patient s primary physician and/or anesthesiologist. 7. Emergency (E) - The Suffix E is used to denote the presumed poor physical status of any patient in one of these categories that is operated on as an emergency. 8. Establish a patent intravenous line to be maintained from the beginning of the procedure until post-procedure discharge criteria are met (NO HEPLOCK). Intavenous line may be established on an as needed basis if only giving sedation medication by mouth. 9. Authorizing the administration of the sedative within the recommended moderate sedation dosage guidelines.

5 Note: An RN or other licensed healthcare provider may conduct the evaluation/assessment, but final responsibility for authorization to administer sedative rests with the physician. 10. Procedure Performed 11. Baseline and on going vital signs, location, 02 SAT, and cardiac rhythm strip 12. IV therapy, including fluid type, amount, and infusion rate. 13. Medication name, route, dose, time, and person administering. 14. Complications or drug side effects and their management. 15. Status of the patient upon conclusion of the procedure. 16. For Outpatients, any of the following methods of documentation by the M.D. will suffice: a) A Short Form H & P (dictated or written w/in 30 days-update day of surgery unless dictated the day of surgery) b) An H & P from the referring physicians office c) The emergency department history & physical evaluation

6 Title/Description: Sedation and Anesthesia Care Page: 7 V. Drug selection (Please see attached Drug List) 1. Drugs approved for use to provide moderate sedation for the performance of diagnostic, radiological or minor surgical procedures outside the operating room; the attached drugs and dosages apply to this policy. This is not an all-inclusive list. 2. The responsible physician may use other medications. All drugs & doses must be individualized for the patient, as response may vary with age, physical status, and concomitant medications. When administered in combinations, even at lower levels than stated above, this policy will apply. Nurses may administer only those drugs approved by the Alabama Board of Nursing. 3. Medications currently used for Procedural Sedation, include, but are not limited to, the sedative hypnotic agents, e.g.-ketamine, Etomidate, and Propofol. VI. Procedure If Sedation exceeds recommended Sedation Dosage Guidelines 1. Physician is notified and shall evaluate the patient s status, if additional monitoring is needed, document. 2. Providing total patient care including resuscitative efforts if needed. 3. Administration of reversal agent.

7 Title/Description: Sedation and Anesthesia Care Page: 8 VII. PreSedation/PreAnesthesia Assessment 1. Select and plan sedation or anesthesia care. Options, risks, are discussed with patient/family. 2. Safely administer moderate or deep sedation & anesthesia. 3. Interpret findings of patient monitoring. 4. Provide anesthesia services within approximately 30 minutes after anesthesia deemed necessary for obstetric services. Immediately available personnel to perform emergency Cesarean delivery for VBAC, for women with a prior uterine scar. VIII. Patient Monitoring During Procedure The following requirements will be met during the procedure: 1. The patient will be monitored for drug effect, pulmonary ventilation, SpO2, level of consciousness, heart rate and blood pressure (for children 3 years, may substitute capillary refill for BP). 2. Cardiac rhythm will be monitored. 3. Physiological monitoring is done. 4. Monitoring parameters, including heart & respiratory rates, blood pressure, Sp02, level of consciousness, and ECG Rhythm, (when applicable) will be documented as follows: a. Prior to the initial dose of sedation. b. At 5 minute intervals throughout the procedure or more frequently as directed by the operating physician. c. Upon completion of the procedure. All patients receiving Moderate Sedation will be monitored until discharge criteria are satisfied.(aldrete Scoring, approved by Medical Staff). Most patients will be discharged from PACU with scores of 9. Chronically debilitated, senile, or paralyzed patients, may be discharged with scores less than 9, these patients must be treated individually and discharged at the discretion of the physician in charge or his/her designee. Patients with pre-procedure scores of less than 9 who have returned to pre-procedure score will be considered a candidate for discharge. See table on the following page for scoring criteria.

8 Title/Description: Sedation and Anesthesia Care Page: 9 IX. Post-Procedure monitoring 1. Level of consciousness, blood pressure, heart and respiratory rates will be obtained at a minimum of the following specified times: a. Upon return from the procedure area b minutes post procedure c. 1 hour post procedure Outpatients who have received reversal agents must be monitored for a minimum of two hours or meet the score of 9 after the last dose of medication prior to discharge. X. Discharge Criteria Regardless of location 1. Score of 9 or above. 2. Alert and oriented. Infants and patients whose mental status was initially abnormal will have returned to pre-procedure level. 3. Vital signs are stable and within acceptable limits. 4. Able to ambulate with minimal assistance or at a pre-procedure level. 5. Minimal nausea, vomiting or dizziness. 6. Outpatients will be discharged in the care of a responsible adult after receiving the following: a. Written discharge instructions regarding post procedure diet, activities, and medications. b. Instructions of adverse symptoms to report following discharge. c. Instructions of whom to notify, should a problem arise following discharge. 7. Accompanied home by family member/significant other. (No driving)

9 Title/Description: Sedation and Anesthesia Care Page: 10 Post Anesthesia Recovery Score In Minutes 2 hrs Out ACTIVITY Able to move 4 extremities voluntarily or on command = 2 Able to move 2 extremities voluntarily or on command = 1 Able to move 0 extremities voluntarily or on command = 0 RESPIRATION Able to deep breathe & cough freely = 2 Dyspnea or limited breathing = 1 Apneic = 0 CIRCULATION BP 20 of Preanesthetic level = 2 BP of Preanesthetic level = 1 BP 50 of Preanesthetic level = 0 CONSCIOUSNESS Fully awake = 2 Arousable on calling = 1 Not responding = 0 COLOR Pink = 2 Pale, dusky, blotchy jaundiced, other = 1 Cyanotic = 0 Minimum time for monitoring post procedure will be 30 minutes. If patient scores 9 after the initial 30 minutes, he/she may be discharged or transferred. NOTE: Only credentialed physicians and CRNA s may administer Fentanyl.

10 Title/Description: Sedation and Anesthesia Care Page: 11 XI. Equipment Equipment for care & resuscitation all ages: a. Basic resuscitative medications b. Appropriate reversal agents such as Narcan (Naloxone) and Romazicon (Flumazenil) c. Appropriately sized O2 delivery devices and airway equipment, Including laryngoscope and endotracheal tubes d. Suction with appropriate suction catheters e. IV therapy equipment f. Cardiac monitor g. Pulse Oximetry with blood pressure apparatus h. Am-bu bag at bedside XII. Quality Assurance and Performance Improvement Each location administering Moderate Sedation Reports quarterly 100% of cases. Any case of Moderate Sedation exceeding the recommended sedation guidelines will be reported to the Quality Management Director.

11 Title/Description: Sedation and Anesthesia Care Page: 12 Any patient receiving dosages in the range described in the table below (for diagnostic and therapeutic procedures outside the OR/PACU setting) shall follow this policy/procedure. Drug Route Suggested Repeat Maximum Pharmacokinetics Reversing usual sedation dose Dose Dose Onset / Duration Agent Meperidine (Demerol) Midazolam (Versed) IV IV IM Child: 0.3 mg/kg Bolus w/ 0.3 mg/kg/hr (up to mg/kg) Adult: mg/dose Admin. over 5 min (IV) ALL PATIENTS RECEIVING VERSED WILL FOLLOW P/P Child: mg/kg Adult: mg/kg Admin. Over 2 min (IV) Child: mg/kg Adult: mg/kg Usual Adult dose = 5 mg After 2-3 min. Oral Child: mg/kg 15mg Morphine IV Child: mg/kg Age >12: 2-4 mg Admin. Over 5 min (IV) Chloral Hydrate (Noctec) 50 mg IV: Onset: With in 5 min Duration: 1-4 hr. Child: Usual mg/kg/min Adult: Usual mg, not more than 2.5mg in a single dose. IV: Onset: With in 3 min Duration: min. IM: Onset: 15 min. Duration: 1-2 hr. After 5 min Child: 15 mg IV: Onset: With in 5 min Duration: 1-2 hr IM Child: mg/kg Child: 15 mg IM: Onset: min Duration: 2-7 hr Oral Child: mg/kg/dose Adult: mg CrCl = 75% Dose CrCl <10 = 50% Dose PO: Onset: 60 minutes Duration: 3-5 hours Oral / Rectal Child: 80 mg/kg Max 1000 mg Child: After 30 min mg/kg 1000 mg Oral/Rectal Onset: 30 min Duration: 4-12 hr Naloxone (Narcan) Child:.01 mg/kg every 2-3 min.prn Adult: 0.4-2mg every 2-3 min.prn Onset: w/in 2 min. Duration: min. Flumazenil (Romazicon) Child: mcg/kg (usu. 10 mcg/kg) Adult: 0.2 mg (2 ml) over 15 sec. Repeat every 60 sec. prn up to 1 mg TOTAL Onset: 1-5 min. Duration: 1-4 hr. Naloxone (Narcan) Diazepam (Valium) IV Child: mg/kg/dose Not more than 1-2 mg/min Adult: mg >65: 2-5 mg Not more than 5 mg/min Child: After 30 min mg/kg every min Child: 0.6mg/kg in an 8 hour period. Adult: 20 mg >65: 10 mg IV Onset: 1-5 min. Duration: min. Flumazenil (Romazicon) PROCEDURAL SEDATION DRUG TABLE Drug Route Suggested Repeat Maximum Pharmacokinetics Reversing usual sedation dose Dose Dose Onset / Duration Agent Ketamine IV mg/kg 5-15 min. 2mg/kg Onset:30sec. Duration: 5-15min. NA Propofol (ICU sedation for Mech Vent) IV Initial: 5mcg/kg/min Maintenance: 5-50mcg/kg/min N/A 50mcg/kg/min Onset:<30sec. Duration: 3-10min. N/A Etomidate IV mg/kg over 30-60sec 4-10 min. 0.6mg/kg Onset: 10-20sec. Duration: 4-10min. N/A

12 Drug Route Suggested Repeat Maximum Pharmacokinetics Reversing usual sedation dose Dose Dose Onset / Duration Agent