Beth Israel Deaconess Medical Center BIDMC Manual Title: Conscious Sedation (Non-Anesthetist Moderate Sedation) Policy #: CP-03 Purpose: To establish one standard of care for administering and monitoring conscious sedation for all patients throughout the medical center. To delineate the practice for the safe and effective administration of conscious sedation (IVCS) in the absence of an anesthesia provider. Procedure(s) for Implementation: I. AUTHORITY Authority for the application of the Beth Israel Deaconess Medical Center policy resides with the Beth Israel Deaconess Medical Center Medical Executive Committee. Privileging of operators and monitors is under the authority of the BIDMC Medical Executive Committee. Individual practitioners and department leaders are responsible for ensuring that those who provide conscious sedation are privileged to do so. Appropriate Quality Improvement efforts and complications review will be performed and reported to PCAC annually. II. INTENT These guidelines are intended to address patients who receive moderate sedation (see below) by non-anesthesiologists. The following populations are excluded from this policy: Patients sedated by a qualified anesthesia provider. Intubated patients receiving intravenous conscious sedation (IVCS) for diagnostic and therapeutic procedures. The care of the pediatric patient. (Neonatal sedation is discussed in the policies of the Neonatal Intensive Care Unit). III. DEFINITIONS Sedation progresses on a continuum. The following definitions illustrate that continuum. 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; CP-03 Moderate sedation/analgesia (“conscious sedation”) Page 1 of 9 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. IV. 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. General Anesthesia Consists of general anesthesia and spinal or major regional anesthesia. It does not include local anesthesia. General anesthesia is a druginduced 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. SEDATION RATING SCALE In order to assess a patient’s response to sedative or analgesic use, the following rating scale is applied: The patient experiences: 0- No sedation, awake S- Sleepy (normal to arouse) 1- Mild sedation (occasionally sleepy, easy to arouse, responds to verbal stimuli) 2- Moderate sedation (frequently drowsy, responds to gentle shake) 3- Severe or deep sedation (somnolent, difficult to arouse, responds to sternal rub) 4- Unresponsive V. PERSONNEL At least two clinicians (Operator and Monitor) privileged in IVCS shall be present whenever IVCS is administered. Both of these two personnel will be available to the patient from the time of sedative/analgesic medication administration until recovery is judged adequate, or the care of the patient is transferred to personnel performing recovery care. CP-03 Page 2 of 9 Operator The physician who administers the conscious sedation must have clinical privileges to perform IVCS. Privileging requires training in the safe use of these drugs and appropriate “rescue training.” Documentation of training will be maintained in the physician’s credentialing and reappointment file. Monitor The monitor must also have privileges in IVCS. S/he must have knowledge and experience in the use of oximetry, cardiac monitoring equipment and in the recognition of cardiac arrhythmias. The Nurse Manager shall certify that the nurse monitor is trained in the safe use of these drugs and appropriate rescue training. Documentation of biannual training will be maintained in the nurse’s educational record. During the administration of IVCS, the monitor should have no other significant responsibilities. When IVCS is administered by non-anesthetists without ACLS or ATLS training, a physician with current training in advanced cardiac life support should be readily available (i.e., in the same or contiguous building) in case of medical complications and emergencies. The means for notifying additional support services such as Respiratory Therapy and for calling cardiac arrest pages should be clearly identified in procedure/sedation areas. When the patient has been identified as “high risk,” or when the procedure to be carried out is particularly complex, a member of the anesthesia care team should be present to assist with the procedure. In elective cases, this must be scheduled with an anesthesiologist at least 24 hours in advance by requesting an Anesthesia Consultation (ext. 7-3112). VI. TRAINING AND PRIVILEGING OF PERSONNEL: The training requirements below pertain to the administration of moderate sedation. No specific training is required to administer minimal sedation (anxiolysis). Only clinicians with privileges in Anesthesia may administer deep sedation or general anesthesia. CP-03 Training requirements for privileging in moderated sedation include education in the safe use of sedation drugs, appropriate rescue training and evidence of clinical experience. As with all Medical Center privileging, the individual practitioner and relevant department leaders are responsible to ensure that those who provide moderate sedation are appropriately trained. The training must be completed at least every 2 years in accordance with the recredentialing requirements. When these training requirements are met, privileges to administer Moderate Sedation may be requested. Page 3 of 9 Training in airway management will be accomplished every two years through completion of ACLS, ATLS, CCMALS or BCLS certification. Those who provide sedation to ASA III or IV patients must obtain ACLS or ATLS certification as cardiovascular instability during sedation is more common among these patients. As an alternative, airway management skills can be obtained through training provided by the Department of Anesthesia and approved by the MEC. Training in the safe use of these drugs shall be achieved through a course offered by the Department of Anesthesia and Critical Care in the use of drugs and monitoring modalities used during conscious sedation. Alternatively, the videotape of this training may be viewed to fulfill the course requirements or an on-line training module can be completed. VII. EQUIPMENT The room where the procedure USING IVCS is scheduled to take place should have adequate, uncluttered floor space to accommodate emergencies. CP-03 The following monitoring and emergency resuscitation equipment should be available and in good working order prior to beginning the procedure. 1. An airway and a self-inflating positive-pressure oxygen delivery system capable of delivering 100% oxygen at a 15 liter/minute flow rate for at least 60 minutes must be available. Various appropriate bag and mask sizes must be available. 2. Supplemental oxygen source 3. Nasal prongs and non-rebreathing or rebreathing oxygen masks 4. A source of suction (portable or wall) 5. An emergency cart or kit including the necessary drugs (including appropriate reversal agents) and equipment to resuscitate an apneic or unconscious patient and provide continuous support while that patient is being transported to another area 6. A pulse oximeter with an alarm 7. A manual or automatic device for measuring blood pressure 8. Cardiac monitor with alarm. The Board of Registration in Medicine recommends the use of cardiac monitors for patients with an ASA classification of III or greater or with a history of cardio-pulmonary disease. Page 4 of 9 9. All equipment shall be inventoried and maintained on a regularly scheduled basis, in conjunction with policies established by the hospital’s Biomedical Engineering Department. VIII. INFORMED CONSENT The informed consent for any short-term therapeutic, diagnostic or surgical procedure in which conscious sedation is to be administered should include the risks of conscious sedation, benefits and alternative options. IX. PRE-PROCEDURE ASSESSMENT AND DOCUMENTATION Prior to the procedure and the initiation of conscious sedation, it shall be ascertained that the patient is an appropriate candidate for conscious sedation utilizing the following criteria: CP-03 1. The patient’s state of consciousness and medical condition are appropriate for the use of conscious sedation. 3. Preparatory studies appropriate to the procedure and the patient have been done, including a determination of the need for blood or blood products or other additional diagnostic data. 3. There is a sedation plan and order written by the physician with clinical privileges to perform the procedure (or his designee), unless that physician will be administering the medication him/herself. 4. The patient has no known allergies or sensitivities to the prescribed medication. 5. The patient has been NPO for at least six hours prior to the planned procedure except for clear liquids, which may be given up to two hours before the procedure. Patients considered to be at risk for aspiration may require a longer NPO period. Medications may be administered with a sip of water. In cases of emergency, where the patient has not been NPO, IVCS may be dangerous. It should either not be administered or administered judiciously to avoid unconsciousness or suppression of protective airway reflexes. 6. The patient/guardian has been informed by the physician of the risks and alternatives to sedation as a component of the planned procedure, and documentation of the patient’s consent has been placed in the patient’s record prior to the procedure. 7. The patient has been instructed: a. In the concepts of conscious sedation and about the sedation Page 5 of 9 b. 8. A physical examination has been conducted which includes assessing/measuring the patient’s: a. b. c. d. e. f. g. 9. planned for the procedure, and To report any problems associated with the procedure or conscious sedation (e.g., pain, tender site, itching, difficulty in breathing) to the individual responsible for monitoring the patient. Actual or estimated height and weight Vital signs (baseline blood pressure; heart rate; respiratory rate, pattern and quality) Baseline oxygen saturation Airway (i.e., an evaluation performed in anticipation of possible intubation, e.g. checking condition of teeth; range of neck motion; ability to open mouth) Chest and cardiac status General neurologic status (e.g., assessing mental status; presence of stroke deficits) and Physical status (ASA physical status category) Health evaluation has been documented including: a. b. c. d. e. f. Allergies and previous adverse drug reactions Current medications Diseases, disorders and abnormalities Prior hospitalizations Pertinent family history of diseases or disorders Review of systems 10. The patient has a functioning IV line or saline lock. 11. The patient’s oxygen requirements are evaluated. The need for administration of supplemental oxygen via nasal prongs should be considered. Patients who are over the age of 60 or who have a medical history significant for heart, lung or kidney disease should be routinely given supplemental oxygen unless specifically contraindicated. 12. A rationale for sedation, sedative plan, and plan for post procedure care are documented. 13. Physician operator shall sign immediate preprocedure assessment and include phone number or page ID. Such an assessment may be abbreviated as appropriate in emergencies. CP-03 Page 6 of 9 X. MONITORING The Board of Registration in Medicine recommends use of a standard real-time form to be included in the medical record, in which the patient’s management and monitoring during IVCS would be documented. 1. 2. XI. During the procedure the designated monitor shall record: a. Heart rate, respiratory rate, blood pressure, sedation score, pain level. If the patient has been classified ASA III or greater, or has a history of cardiopulmonary disease, heart rate, and rhythm should be displayed continuously on a cardiac monitor. The oxygen saturation should be continuously displayed and recorded at 5minute intervals. b. Medication given (route, site, time, drug, and dose), including oxygen therapy in liters/minute and means of delivery (e.g., nasal prongs). c. The patient’s head position should be checked frequently to ensure a patent airway. d. If the patient becomes unstable during the procedure, appropriate medical consultation should be sought immediately. Following the procedure: The nurse in the post procedure area should continuously monitor the patient, and document vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation, pain level) at 15-minute intervals for a minimum of 30 minutes following the end of the procedure. Beyond this thirty minute period, and, if stable, the above parameters should be monitored every 15 minutes until the patient has returned to preprocedure condition, or is transferred to other personnel performing recovery care. Functioning suction apparatus and capability for delivering more than 90% oxygen with bag and mask must be readily available in the post procedure recovery area. The patient must be observed for a minimum of 30 minutes following the procedure, and for two hours if reversal agents including flumazenil or naloxone have been given to reverse sedative/analgesics. POST-PROCEDURE PATIENT CARE AND DISCHARGE PLANNING 1. Transfer to a nursing unit will only be permitted when the patient’s PAR CP-03 Page 7 of 9 score is 8 or above or at baseline. Patient has stable vital signs (blood pressure, pulse, respiratory rate) and oxygen saturation (Sa02). Patient’s swallow, cough, and gag reflexes are present as appropriate to baseline. Patient is alert or appropriate to baseline. Patient’s activity level is at pre-sedation baseline. 2. Discharge to home will be permitted when the patient’s PADS score is 9 or above or at baseline. Patient has stable vital signs. Patient can sit unaided if appropriate to baseline and procedure. Patient can walk with assistance if appropriate to baseline and procedure. Nausea and dizziness are minimal. Hydration is adequate. Dressing/ procedure site have been checked if applicable. Discharge order has been written by the physician, or readiness for discharge has been determined by the RN using established criteria. 3. For patients being discharged to return home, the following apply: a. The ambulatory care patient may not leave the premises unless they are under the care of a competent adult. b. 4. Written patient instructions include an explanation of potential or anticipated post sedation effects and limitations on activities and behavior including dietary precautions. Patients should be advised to refrain from operating heavy machinery, driving a car, consuming alcohol, and making important decisions for 12 to 24 hours. A 24-hour emergency contact telephone number should be provided. If the patient is being transferred for further care within the facility, standard criteria for inter-unit transfer should be met. Vice President Sponsor: Ken Sands, MD, VP, Health Care Quality Approved By: Medical Executive Committee: 5/26/04 Mary Anne Badaracco, MD Chair, MEC Requestor Name: Steven Pratt, MD Date Original Approved: 10/01 CP-03 Page 8 of 9 Next Review Date: 05/01/07 Revised: 5/26/04 Eliminated: References: See Conscious Sedation in the BIDMC Manual of Clinical Practice. Changes made to this document must also be made in the Manual of Clinical Practice. CP-03 Page 9 of 9