SINAI HOSPITAL OF BALTIMORE PATIENT CARE SERVICES POLICY AND PROCEDURE MANUAL

SINAI HOSPITAL OF BALTIMORE PATIENT CARE SERVICES POLICY AND PROCEDURE MANUAL SUBJECT: SCOPE: Moderate (Procedural) Sedation Medical Center Complex PURPOSE: To provide a standard of care for sedation prior to invasive and noninvasive procedures when sedation is used. RESPONSIBILITY: Physicians and Registered Nurses who have completed procedural sedation education and competency. DEFINITIONS: 1. Minimal Sedation (anxiolysis): A drug-induced state in which patients respond normally to verbal commands. Although cognitive function and coordination and coordination may be impaired, ventilatory and cardiovascular functions are unaffected. 2. Moderate/Procedural 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. Reflex withdrawal from a painful stimulus is not considered a purposeful response. No interventions are required to maintain a patent airway and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. LOSS OF AIRWAY REFLEXES IS DEEP SEDATION, NOT MODERATE SEDATION. 3. Deep sedation/analgesia: A drug-induced depression of consciousness during which patients cannot be easily aroused but responds 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: Anesthesia consists of general 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 may be impaired. Patients often require assistance in maintaining a patent airway and positive pressure ventilation may be required because of depressed spontaneous ventilation or druginduced depression of neuromuscular function. Cardiovascular function may be impaired. POLICY: 1. The registered nurse may NOT administer procedural sedation prescribed by a

SUBJECT: Moderate (Procedural) Sedation 2 physician assistant, licensed podiatrist or licensed dentist. However, the registered nurse may administer moderate sedation prescribed by dentists whose specialty training and board certification designate them as experts in basic airway management and basic principles and pharmacology of moderate sedation (Oral and Maxillofacial surgeons). 2. Patients may receive moderate sedation by any route administered by physicians, or Registered Nurses under physician supervision, for the performance of procedures. 3. Because anesthesia is a continuum, it is not always possible to predict the patient s response. Therefore if a deeper level of sedation than anticipated occurs and/or the patient is at risk for loss of protective reflexes, the procedure should be interrupted and all efforts directed toward stabilizing the patient and securing the immediate return of a decreased level of sedation. If the patient cannot be immediately stabilized, appropriate assistance should be obtained by using Airway Emergency or Code Blue procedure as appropriate. 4. General anesthesia and deep sedation with planned loss of consciousness will be provided only by a qualified anesthesia provider. 5. The registered nurse may NOT administer moderate/procedural sedation utilizing medications classified as an anesthetic agent to include but not limited to propofol, ketamine or inhalation anesthetics. Exception: Ketamine may be administered by registered nurses to pediatric patients in the PICU. 6. The registered nurse may not administer sedation to a patient who is ASA IV (or Mallampati 3 or higher. 7. An anesthesia consultation is RECOMMENDED if a patient has known respiratory compromise or hemodynamic instability; presents with significant comorbid conditions or sleep apnea; and has a ASA physical status of 4. 8. An anesthesia consultation is REQUIRED for pateints with an ASA physical status of 5; infants who are born prematurely(<37 weeks gestation) who at the time of the procedure are <60 weeks postconception and who are not residing in the neonatal intensive care unit or pediatric intensive care unit (note: postconceptual age is the gestational age at birth plus the age since birth {e.g., a baby born at 32 weeks who is 12 weeks old is 44 weeks postception}; patients with a history of airway problems during sedation/analgesia or general analgesia; patients with a history of adverse reaction to sedation/analgesia or general anesthesia; children with neuromuscular disease affecting respiratory or brain stem function; and patients who fail airway screening examination. 9. A patent IV line is required in adult patients. 10. Prior to the procedure beginning, the nurse has the right and responsibility to

SUBJECT: Moderate (Procedural) Sedation 3 REFUSE to administer the medication for moderate/procedural sedation when: a. the medication is one the nurse is prohibited from administering; b. in the registered nurse s professional judgment, the patient s clinical status is compromised and proceeding would place the patient at unnecessary risk; c. the initial prescribed dose of the medication is outside the recommended dosage parameters and may place the patient at risk of deep sedation ( appendix A). 11. During the course of the procedure, the registered nurse has the right and the responsibility to REFUSE to administer subsequent doses of procedural sedation in amounts that may convert the patient s state to deep sedation or cause decompensation of the patient s vital signs. 12. When the registered nurse REFUSES to administer procedural sedation given the circumstances listed above in # 8 or #9, and when the physician performing the procedure assumes responsibility for administering of the medications, the registered nurse has the right and the responsibility to REFUSE to monitor the patient. If this occurs the nurse must notify the charge nurse/manager/hospital operations coordinator (HOC). The nurse must continue to monitor the patient until relieved. 13. The registered nurse must report when he/she has refused to administer or monitor in accordance with the performance improvement process. 14. There is no limit on the length of time the registered nurse may administer procedural sedation. 15. The registered nurse may NOT obtain informed consent for the administration of moderate/procedural sedation. 16. An operative report must be written by the physician immediately after the procedure. 17. Post-Procedure Recovery: Physicians performing the procedure are responsible for the patient in the post-procedure recovery. Post-procedure recovery will occur as per postanesthesia care guidelines. Patients must be recovered in a designated recovery area. 18. Recovery Room Discharge Criteria: Discharge from the recovery area will follow the anesthesia discharge criteria guidelines: a. Recovery score >/= 12 b. No recovery score individual criteria = to 0 unless discussed with the anesthesiologist c. IV opioids administered not less than 15 minutes previously and respiratory rate must be >/= to 8 for adults, normal respiratory rate for children according to age. 19. An adult must accompany the patient home. PROCEDURE: 1. Exemptions:

SUBJECT: Moderate (Procedural) Sedation 4 a. Adult patients less than 70 years of age and pediatric patients greater than 12 years of age who receive Diazepam 5 to 10mg or Lorazepam 1 to 2mg PO. b. Adult mechanically ventilated patients, except for those receiving a bolus dose of propofol. Non-anesthesia providers may not administer IV bolus propofol. c. Patients who require sedation secondary to an acute psychiatric disturbance which may result in potentially harmful behavior. 2. The Chief of each Medical or Surgical Service is responsible to determine physician competency and sign off delineation of privileges. The physician supervising or administering the sedation must attend a mandatory review of the moderate/procedural sedation procedures every 2 years. 3. Patient Selection/Classification: The physician should evaluate if the patient is an appropriate candidate for moderate sedation based on the ASA Pre-Anesthesia Assessment The American Society of Anesthesiologists define each of the ASA classifications to be: Class I: A normal healthy patient other than surgical pathology-without systemic disease. Class II: A patient with mild systemic disease no functional limitations. Class III: A patient with moderate to severe symptoms disturbance due to medical or surgical disease some functional limitation but not incapacitating. Class IV: A patient with severe systemic disturbance, which poses a constant threat to life and is incapacitating. Class V: A moribund patient not expected to survive 24 hours with or without surgery. Class E: If the case is an emergency, the physical status is followed by the E - e.g. IIE. In addition, the airway must be evaluated by using an airway classification system (Appendix B mallampati classification) as well as by examining and reviewing the following elements: History of airway difficulty? History of previous difficult intubation? Limitation of neck mobility? Limitation of mouth opening? History of excessive snoring or sleep apnea? Facial deformities? Mediastinal disease? 4. NPO Requirements: Adults a. Solids and Non-Clear Liquids- 8 hours or none after midnight. This includes milk and formula (high fat content may delay gastric emptying) b. Clear Liquids 2 hours. Sips of water may be utilized up until the procedure to facilitate patients taking necessary P.O. medications. 5. NPO Requirements: Children and Infants Table 1. Summary of Fasting Recommendations to Reduce the Risk of Pulmonary Aspiration*

SUBJECT: Moderate (Procedural) Sedation 5 Ingested Material Minimum Fasting Period (hour/s) Clear liquids 2 Breast milk 4 Infant formula 6 Non-human milks 6 Light meal(no fatty foods or meat, see note below) 6 Solid food not included in light meal above 8 *These recommendations apply to healthy patients who are undergoing elective procedures. They are not intended for women in labor. Following the Guidelines does not guarantee complete gastric emptying. The fasting periods noted above apply to all ages. Examples of clear liquids include water, fruit juices without pulp, carbonated beverages, clear tea, and black coffee. Since non-human milk is similar to solids in gastric emptying time, the amount ingested must be considered when determining an appropriate fasting period. Light meal typically consists of toast and clear liquids. Meals that Include fried or fatty foods or meat may prolong gastric emptying time. Both the amount and type of foods ingested must be considered when determining appropriate fasting period. These guidelines apply to HEALTHY patients (only): The last clear liquids should be limited to a maximum of 8 ounces. A. Clear liquids include: Water, glucose water, apple juice and ginger ale. Breast milk is NOT treated as a clear liquid. Clear liquids DO NOT include orange juice, milk, formula, etc. B. Oral medications that are required such as anti-convulsants, antihypertensives, etc. may be taken p.o. on the day of surgery with a sip of water. Patients with medical problems such as diabetes, renal failure, increased intracranial pressure, morbid obesity, hiatal hernia or acid reflux, etc. should be NPO solid food after midnight prior to day of surgery or 8 hours prior to surgical procedure. 6. In urgent, emergency, or other situations when gastric emptying is impaired, the potential for pulmonary aspiration of gastric contents must be considered in determining the timing of the intervention and the degree of sedation/anesthesia. Diabetic patients may have delayed gastric emptying and may not have an empty stomach at 6 hours. If the NPO guidelines can not be met, the use of gastric motility agents (Metoclopramide 10 mg IV) and histamine-antagonist agents (Raniditine 50 mg IV) in adult patients is recommended to decrease the risk of pulmonary aspiration of gastric contents. 7. Pre-procedure Testing and Assessment Requirements: Pre-procedure laboratory testing should be guided by the patient s underlying medical condition and the likelihood that the results will affect the management of moderate/procedural sedation.

SUBJECT: Moderate (Procedural) Sedation 6 8. Informed consent for sedation (before utilizing moderate/procedural sedation) is obtained by the physician and will include information about the sedation, and risks and benefits of sedation. The sedation consent is separate from the procedure consent and must be present before sedation can be administered. Sedation consent can be included on the procedure consent form as long as information about the sedation and risks and benefits of sedation is addressed. 9. History and Physical (H&P): An H&P that has been completed 24 hours prior to admission or completed by a physician that does not have privileges at Sinai requires an update. Evaluation of the patient s airway, heart and lungs, and assessment of mental status will be conducted immediately prior to administering the sedation. This immediate pre-sedation assessment will be documented on the Moderate/Procedural Sedation pathway prior to the sedation being given. 10. Special Equipment: Equipment appropriate for the size of the child or adult being sedated, must be secured, checked and located to provide immediate access to patient (bedside, exam table, etc.) before sedation and analgesia are given. Minimum equipment must include: Blood pressure monitoring system (manual or automatic) Pulse oximeter with alarm Operating all O2 source with a flow meter or a full portable O2 tank capable of delivering 60 minutes of oxygen Suction source with regulator (wall or portable) Suction canisters Intravenous access equipment Medications (sedatives, analgesics, antagonists and emergency drugs) Bag-mask ventilation equipment A cardiac monitor and defibrillator Cricothyroidotomy kit, (i.e. 14 gauge needle, scalpel, kelly clamp, and cricothryroid tube). 11. Medications: a. Only Anesthesia personnel can administer Propofol (Diprivan), ketamine, and etomidate. The rationale for this decision is the significant potential for unanticipated deep sedation and/or induction of anesthesia with the risk for loss of protective reflexes. b. Administration of ketamine to a patient in the Pediatric ICU can take place by a pediatric intensivist under the direction of a pediatric anesthesiologist. c. Administration of chloral hydrate pre-procedure cannot occur outside the hospital complex setting. d. Only a physician supervising the procedure can order medications. 12. Personnel: a. A physician, nurse practitioner or certified nurse midwife will continuously supervise sedated patients. The use of moderate sedation requires a minimum of

SUBJECT: Moderate (Procedural) Sedation 7 one R.N. to be present during the procedure so that ongoing monitoring of cardiorespiratory status can be assured. The RN may not leave the patient's bedside. b. The R.N. administering the medication and monitoring the patient must have met the following educational requirements: Basic A&P specific to the defined patient population Pharmacology of the medications given during procedural sedation including: Dosage parameters appropriate to the age and weight of the patient and over what period of time these drugs should be administered; Mechanism of action of commonly prescribed procedural sedation medication(s); Contraindications(s) to the administration of each procedural sedation medication and the appropriate interventions; the effects of procedural sedation medication(s) on the patient s pre-existing conditions. Side effects and complications associated with each procedural sedation medication and the appropriate reversal agents(s). Mechanism of action and use of appropriate reversal agents. Considerations relative to common therapeutic, diagnostic or surgical procedures and the administration of procedural sedation, (an example is the prone positioning for Endoscopic Retrograde Cholangio Pancreatography (ERCP). c. Familiarity/or orientation to the practice setting in which the registered nurse would be administering the procedural sedation. d. Principles of oxygen delivery. e. Knowledge regarding resuscitation, airway management, and life threatening dysrhythmia recognition. f. Completion of Basic Life Support (BLS) for the Health Care Provider g. Knowledge of medical and legal implications, responsibilities and ramifications of administration of procedural sedation. h. Completion of a supervised clinical practicum to obtain competency prior to performing procedural sedation. i. The registered nurse administering the procedural sedation must have the primary responsibilities for monitoring the patient during the procedure and may not leave the patient unattended or engage in uninterruptable tasks that would compromise continuous monitoring. 13. Intra-Procedure Monitoring Adults: Monitoring minimally will consist of pulse, respiratory rate, blood pressure, continuous cardiac monitoring, pulse oximetry, and response to verbal commands. Monitoring will be done continuously and documented on the moderate sedation clinical pathway form every 5 minutes.

SUBJECT: Moderate (Procedural) Sedation 8 14. Intra-Procedure Monitoring Pediatric and Infant: The American Academy of Pediatrics (AAP) Guidelines for moderate sedation in children will be applied for all forms of sedation except IV medication. a. Equipment for IV Line placement should be immediately available. b. BP monitoring should be available. c. A pulse oximeter must be used continuously. d. An ECG will be used continuously. 15. When the registered nurse is administering procedural sedation, he/she is expected to consider the potential risk factors that singly or in combination could increase the risk of complications associated with procedural sedation. These include but are not limited to: a. The frail patient and the patient with extremes of age. b. Inability to communicate or cooperate as in compromised mental status or language barrier. c. Significantly developmentally delayed. d. Severe morbidity or co-morbidity (e.g. cardiac, pulmonary, hepatic, hematological, renal, central nervous system, musculoskeletal, endocrine and, or multiple medications). e. Morbid obesity (BMI>40). f. History of snoring g. History of documented sleep apnea. h. History of drug, alcohol, tobacco use or abuse. i. Pregnancy. j. Emergency procedure with lack of patient preparation. k. Airway anomalies. l. Previous adverse experience with sedation, analgesia or anesthesia. m. Unstable vital signs (low blood pressure, tachycardia, or bradycardia). n. Pulse oximetry of 92 (pediatric patient 95) or below on room air. o. Implantable devices (i.e. epidural pumps, pacemakers, etc). p. Use of narcotics within 24 hours of procedure. q. Recent colds, flu or fever. 16. These above risks may be reduced by consultation with the appropriate specialist or anesthesia provider or both. The patient s morbidity or co-morbidity may also indicate the need for pre-procedure testing or diagnostic studies or both, which can reduce the risk of complications. When, in the professional judgment of the registered nurse, the patient s risk factors are such that the registered nurse elieves tbhere is substantial jeopardy to the patient, the registered nurse has the right and the obligation to REFUSE to administer the procedural sedation. 17. Outcomes: The nurse caring will monitor specific outcomes related to the administration of moderate sedation for the patient receiving moderate sedation on an ongoing basis. Outcome monitoring tool is completed immediately after the procedure.

SUBJECT: Moderate (Procedural) Sedation 9 DOCUMENTATION: 1. A brief discharge note must be written. Discharge instructions to include, as appropriate: a. Medication b. Diet c. Activity d. Wound Care e. Follow-up appointment for post-op care. 2. Moderate Sedation Pathway 3. Informed Consent 4. Discharge Instruction Sheet 5. Provider Orders STATEMENT OF COLLABORATION: Anesthesia, Nursing CROSS REFERENCES: Patient Care Services: Do Not Resuscitate Patient Care Services: Informed Consent Patient Care Services: Code Blue/Medical Emergency Patient Care Services: Airway Emergency Maryland Board of Nursing Declaratory Ruling DR-2003-3 -Registered Nurse Administration of Procedural Sedation for Operative, Invasive and Diagnostic Procedures and for Episodic Treatments or Therapies for the Adult and Pediatric Patient, (e.g. Intravenous, Intramuscular, Inhalation, Oral, Rectal, and Intranasal) Original: Jun., 1996 Reviewed: Apr.,2001 Diane Johnson, RN, MBA Revised: 1997, 1999, 4/2004, 12/05, 5/08 Vice President, Patient Care Services MEC: Sep., 1999; Dec 2005 Chief Nursing Officer (Discharge Criteria) REFERENCES: JCAHO. 2006. Comprehensive Accreditation Manual for Hospitals: The Official Handbook. Oakbrook Terrace, Chicago. University Healthsystem Consortium. 2005. Moderate Sedation Best Practice Recommendations. Oakbrook Terrace, Chicago.

Appendix A Medications Used for Moderate Sedation Medication Administration Guidelines Adverse Reactions Notes and Precautions Morphine Sulfate Adult: 2-10 mg Pediatric: 0.05 0.2 mg/kg. Administer slowly. Total dose; 100 mg in 60 minutes. Onset: 1-3 minutes. Peaks 10-20 minutes. Duration: 1-2 hours. Respiratory depression, circulatory depression including orthostatic hypotension), bradycardia, nausea, vomiting, constipation, urinary retention, dizziness, sedation, weakness, agitation, seizures, altered consciousness, sweating, flushing, pruritis, anaphylaxis. Fentanyl Meperidine Hydrochloride Adult: 25-150 mcg slowly IV. Pediatric: 2-5 mcg/kg Onset: 1-1.5 minutes. Peak: 5-15 minutes. Duration: 30-60 minutes. Half-life: 3-4 hours. Adult: 10-30 mg slowly. Total dose: 100 mg in 60 minutes. Pediatric: 1-1.5 mg/kg. Respiratory depression, circulatory depression, orthostatic hypotension, bradycardia, dizziness, mental status changes, agitation, nausea, vomiting, constipation, urinary retention, sweating, flushing, puritis, seizures, rigidity, loss of consciousness, anaphylaxis. Respiratory depression, circulatory depression including orthostatic hypotension), tachycardia, nausea, vomiting, constipation, Monitor per SHOB policy. Pulse oximetry may show oxygen desaturation before overt signs of distress. Monitor for hypotension particularly if the patient has pre-existing hypovolemia. Monitor per SHOB policy. Respiratory depression is potentate when used with benzodiazepines. Metabolite (normeperidine) may accumulate in patients with renal failure; CNS excitability, agitation, seizure.

Diazepam Midazolam Lorazepam Onset: 1-5 minutes. Peaks: 10-20 minutes. Duration: 1-2 hours. Adult: 2-5 mg (rate of administration not to exceed 5 mg/min). Maximum dose: 20 mg. Pediatric: 0.04-0.3 mg/kg Onset: 1-5 minutes. Peak: 10-30 minutes. Duration: 2-6 hours. Adult: Initial: 0.03 mg/kg over 2 minutes. Additional doses may be given at 2 minute intervals to a maximum dose of 0.2 mg/kg. Pediatric: 0.02-0.05 mg/kg. Onset: 1.5 minutes. Peak: 10-15 minutes. Duration: 1-2.5 hours. Adult: 0.02-0.04 mg/kg. Maximum: 2 mg. Pediatric: 0.03-0.05 mg/kg. Onset: 30-60 minutes. Duration: 6-8 hours. urinary retention, dizziness, sedation, weakness, agitation, seizures, altered consciousness, sweating, dry mouth.. Respiratory arrest, especially in the elderly or those with diminished respiratory reserve; cardiovascular collapse, hypotension, thrombosis, phlebitis, diminished mental status, paradoxical reactions (hyperexcitiability, anxiety). Respiratory depression, circulatory depression, orthostatic hypotension, bradycardia, dizziness, mental clouding, sedation, agitation, seizures, altered consciousness, nausea, vomiting, constipation, urinary retention, sweating, flushing, pruritis, anyphylactoid reactions. Respiratory depression, hypotension, arrhythmias, vomiting, dizziness, blurred vision, agitation, muscle weakness. Diazepam has an extremely long half life (20-90 hours) and has active metabolites so duration of action can be prolonged. Flush tubing immediately after administration with 0.9% NaCl. Midazolam has no analgesic properties. Thrombosis and phlebitis may occur at the site of injection. Produces sedation and amnesia, no analgesia.

Ketamine Naloxone Hydrochloride Pediatric: 0.5 2 mg/kg Onset: I minute Duration: 5-10 minutes Adult: Initial: 0.1-0.2 mg. Can be repeated in 2-3 minute intervals. Pediatric: Infants and children < 5 years or < 20 kg: 0.1 mg/kg; Children > 5 years or > 20 kg: 2 mg/dose. Hypertension, tachycardia, paradoxical direct myocardial depression, hypotension, bradycardia, increased intracranial pressure, hypersalivation, vomiting. Excitement, hypotension, hypertension, ventricular tachycardia and fibrillation, pulmonary edema, tremor, hyperventilation, nausea, vomiting, sweating circulatory stress. Administer slowly, do not exceed 0.5 mg/kg/min, do not administer faster than 60 seconds, do not exceed final concentration of 2 mg/ml Duration of action is less than 30 minutes, which may be less than that of the narcotic with the reappearance of narcosis. Flumazenil Adult: Initial dose: 0.2 mg over 15 seconds. Second dose can be given after 45 seconds. If necessary the dose of 0.2 mg may be repeated at 60-second intervals to a maximum dose of 1.0 mg. Pediatric: Initial dose: 0.01 mg/kg with repeat doses of 0.01 mg/kg Nausea, vomiting, dizziness, confusion, recurrence of sedation, headache, vasodilatation (hot flashes, flushing, sweating), parathesia, motional liability, abnormal vision, fatigue, tachycardia, seizures.