Vanguard Health Management, Inc. Sedation Analgesia Moderate/Deep

Sedation/Analgesia (Moderate/Deep)

Policy & Procedure

I.Purpose

To establish guidelines and procedures for administration of sedation/analgesia given by physicians who are not specialists in anesthesiology.

To establish guidelines and procedures for monitoring patients receiving sedation/analgesia as part of diagnostic, therapeutic or invasive procedures.

II.Scope

This policy applies to all patients, in any setting, for any purpose, by any route, that receive sedation/analgesia for a diagnostic, therapeutic or invasive procedure. All patients who are undergoing procedures and receiving sedation/analgesia prior to and during the procedure will receive one standard of care throughout the facility.

This policy DOES NOT:

  • Include patients who require general anesthesia and have lost protective reflexes and are unable to maintain a patent airway independently
  • Include patients who require therapeutic pain management
  • Include patients who require sedation for maintenance on a ventilator
  • Include patients who require sedation to control seizures
  • Include patients that undergo monitored anesthesia care (MAC) given by anesthesia providers

III.Definitions

Degrees of Sedation

The American Society of Anesthesiologists (ASA) recognizes the following levels of sedation/analgesia and anesthesia: minimal, moderate (conscious sedation), deep and general anesthesia. The various degrees of sedation occur on a continuum: minimal, moderate, deep, and general anesthesia. The patient may progress from one degree to another, based on the medications administered, route, dosages, age and physical status of the patient. The determination of patient monitoring and staffing requirements will be based on a patient’s acuity and the potential response of the patient to the procedure. Only qualified individuals will administer pharmacological agents to predictably achieve desired levels of sedation and monitor patients in order to maintain them at the desired level of sedation.

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.

Sedation - represents a continuum of consciousness to unconsciousness with three levels most commonly described: minimal, moderate, and deep sedation.

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.

Moderate sedation/analgesia (formerly 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. Sedation/analgesia is generally achieved when there is slurred speech, but the patient is arousable, able to respond, and retains the ability to independently maintain a patent airway.

(Note: Reflex withdrawal from a painful stimulus is NOT considered a purposeful response.)

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.

IV.Policy

  1. Sedation/analgesia is provided by physicians that have received training in the administration of pharmacological agents for diagnostic or therapeutic procedures. The physician must be trained in and capable of managing airways and have clinical privileges to administer sedation/analgesia.
  1. Individuals that provide sedation/analgesia should also be trained on standards and techniques to monitor patients carefully in order to maintain them at the desired level of sedation and to manage complications of sedation techniques.
  1. Individuals administering sedation/analgesia will have the appropriate credentials to manage patient at whatever level of sedation is achieved, moderate or deep, either intentionally or unintentionally. Physicians may request clinical privileges for moderate sedation/analgesia (conscious sedation), deep sedation, or both. The chairperson of the Anesthesia Committee will review each request for initial and subsequent clinical privileges for sedation (moderate or deep) and forward the findings to the Credentials Committee.
  1. The physician has the ultimate responsibility for the safety and welfare of the patient undergoing sedation. A history and physical evaluation performed by the physician must be obtained prior to administering medication for sedation/analgesia cases.
  1. Physicians who provide sedation/analgesia must be re-credentialed every two years. Nursing staff that provide assistance during sedation/analgesia must demonstrate competency on an annual basis.
  1. Sedation/analgesia may be administered by the attending Physician, consulting Physician, or RN under the direct supervision of a physician who has been granted sedation/analgesia privileges. (EXCEPTION: Deep sedation agents, such as Methohexital [Brevital] and Fentanyl may only be administered by a physician).
  1. The nurse responsible for monitoring the patient should have completed appropriate education and training related to sedation/analgesia, be able to demonstrate a working knowledge of resuscitation equipment, be able to demonstrate the function and use of monitoring equipment, and be able to interpret data obtained.
  1. Appropriate medical specialists should be consulted before administration of sedation/analgesia to patients with significant underlying conditions. The choice of specialists depends on the nature of the underlying condition and the urgency of the situation. If it appears likely that sedation to the point of unresponsiveness or general anesthesia will be necessary to obtain adequate conditions, practitioners who are not specifically qualified to provide these modalities should consult an anesthesiologist.
  1. The minimum number of available personnel for a procedure involving moderate sedation/analgesia is two: a Physician who performs the procedure, and a registered nurse (RN) who continuously monitors the patient and assists in any supportive or resuscitative measures. Both personnel must be present during the initial and continued administration of sedation/analgesia and remain in attendance until the patient’s vital signs and state of consciousness are at baseline or stable.
  1. The minimum number of available personnel for a procedure involving deep sedation/analgesia is three: a physician who performs the procedure, a registered nurse (RN) who continuously monitors the patient and assists in any supportive or resuscitative measures and a second nurse (RN or LVN) or technician (GI Lab tech, Radiology tech, etc). A respiratory therapist is optional at the physician’s request for deep sedation procedures.
  1. Emergency resuscitation equipment to monitor the patient’s heart rate and oxygenation will be available and in the patient’s room or procedure area during sedation/analgesia.
  1. The physician is responsible for obtaining informed consent for the procedure and for sedation/analgesia prior to a procedure involving sedation/analgesia. Relative to the planned procedure and the sedation/analgesia, information is provided regarding the following:
  1. Potential benefits and drawbacks;
  2. Potential problems related to recuperation;
  3. Likelihood of success;
  4. Possible results of non-treatment; and
  5. Any significant alternatives.
  1. A history and physical examination performed by a physician and a nursing assessment and individualized nursing care plan are required for each patient before any procedure involving moderate or deep sedation/analgesia. The physician must state whether moderate or deep sedation will be used. The physician must determine and document that the patient is an appropriate candidate for the level of sedation selected. The RN should prioritize the patient’s nursing care needs.
  1. The physiological status (i.e., BP, HR, RR, O2 sat, EKG, LOC) of each patient undergoing moderate or deep sedation/analgesia is monitored before, during and following the procedure.
  1. The nurse will collect, analyze and document each patient’s physiological information during the post-sedation period to establish eligibility for discharge according to approved criteria.
  1. Patients are discharged from the post-sedation area by a qualified physician OR according to criteria approved by the Department of Anesthesia.
  1. The Department of Anesthesia will oversee sedation/analgesia practices (policies, procedures, credentialing) throughout the hospital to assure optimal patient outcomes. The Department of Anesthesia will follow-up adverse outcomes and report their findings and recommendations to the Medical Executive Committee as needed.
  1. The sedation/analgesia policy is employed when the following agents are used in conjunction with a therapeutic, diagnostic or invasiveprocedure:
  • IV/IM narcotics employed with IV/IM benzodiazepine, OR
  • IV/IM diazepam or midazolam employed +/- narcotic, OR use of methohexital (Brevital)
  • Opioid or mixed agonist/antagonist, OR
  • PO/PR Chloral Hydrate

The sedation/analgesia policy is NOT employed with the use of:

  • Pre-operative benzodiazepine for anxiolysis, OR
  • Oral benzodiazepine is the only medication (e.g., lorazepam dose 2 mg)
  1. The administration of intravenous sedation/analgesia will be limited to medications approved by the Department of Anesthesia at the recommended doses (See Dosing Guidelines for Sedation/Analgesia). The doses may be repeated as indicated to achieve adequate sedation/analgesia.
  1. In emergent situations (life or limb), physicians may deviate from the policy and guidelines and use their professional judgment to meet the immediate acute care needs of the patient.
  1. Sedation/analgesia may be performed in the following areas:

Critical Care Units Cardiac Catheterization Laboratory

Emergency DepartmentMedical – Telemetry

Radiology, including MRILabor and Delivery

Outpatient Surgery/ GI Lab / EndoscopyPediatrics

V.Attachments

Appendix A – Fasting Guidelines

Appendix B - Dosing Guidelines for Moderate Sedation/analgesia – Adult

Appendix C – Dosing Guidelines for Moderate Sedation/analgesia – Pediatric

Appendix D – Dosing Guidelines for Deep Sedation – Adult, Pediatric

Appendix E – Dosing Guidelines for Reversal Agents – Adult, Pediatric

Appendix F - Comparison of Equipment and Personnel – Moderate and Deep Sedation

Appendix H - Patient Instructions – Pre-Sedation and Post-Sedation

Appendix I - Sedation/Analgesia Workshop

VI.PROCEDURE

  1. PHYSICIAN PRIVILEGES AND CREDENTIALING
  1. Physicians will be granted privileges to administer sedation/analgesia based on the following criteria:

a)Be knowledgeable of proper dosages, administration, adverse reactions, and interventions for medications used to procedure sedation analgesia – moderate or deep.

b)Be knowledgeable regarding reversal agents.

c)Be knowledgeable regarding medications used to rescue the patient should undesired effects of sedation analgesia occur.

d)Know how to evaluation and recognize airway obstruction and demonstrate skill in airway management and resuscitation. BLS is required or comparable training for moderate and deep sedation.

e)Assess total patient care requirements/parameters, including but not limited to, respiratory rate, oxygen saturation, blood pressure, cardiac rate and rhythm, and level of consciousness.

f)Have the knowledge and skills to intervene appropriately in the event of complications.

  1. Physician Credentialing

Moderate sedation

a)Initial credentialing - Physicians desiring moderate sedation/analgesia privileges must do the following:

  • Indicate this request on initial application for privileges.
  • Demonstrate evidence of successful completion of six (6) or more moderate sedation/analgesia cases done in the last 12 consecutive months
  • Demonstrate evidence of current BLS certification or comparable training or have documentation of completing a course in basic airway management sufficient to rescue the patient from deep sedation.
  • Sign an acknowledgement indicating they have read the institution’s policy (and Appendices) and that it is understood.
  • Have the privileges approved by the board of trustees based on the recommendation from the medical executive committee.

b)Re-credentialing (every 2 years) – Physicians that desire to continue with moderate sedation/analgesia privileges must do the following:

  • Indicate this request on re-application for privileges
  • Comply with all of the requirements of initial credentialing

Deep Sedation

a)Initial credentialing - Physicians desiring deep sedation/analgesia privileges must do the following:

  • Indicate this request on initial application for privileges.
  • Demonstrate evidence that he/she has twelve (12) cases where deep sedation has been administered in the last twelve (12) consecutive months.
  • Demonstrate evidence of current BLS certification or comparable training or have documentation of completing a course in basic airway management sufficient to rescue the patient from general anesthesia.
  • Sign an acknowledgement indicating they have read the institution’s policy (and Appendices) and that it is understood.
  • Have the privileges approved by the board of trustees based on the recommendation from the medical executive committee.

b)Re-credentialing (every 2 years)– Physician that desire to continue with deep sedation/analgesia privileges must do the following:

  • Indicate this request on re-application for privileges.
  • Comply with all of the requirements of initial credentialing

B. ELIGIBILITY FOR SEDATION

1. Eligibility for Sedation. Patients who are American Society of Anesthesiologists (ASA) Class I and II are considered appropriate candidates for sedation/analgesia or deep sedation out of the operating room environment. Patients in ASA III, IV, or V present special problems that require additional and individual consideration. The physician performing the sedation/analgesia procedure will use his/her professional judgment in requesting an anesthesia consult. ASA Classifications are determined by the physician ordering sedation.

Table 1. American Society of Anesthesiologists – Physical Status Classification
Class / Summary
Class I / A normal healthy patient.
Class II / A patient with mild systemic disease and no functional limitations. Examples: non-OR only slightly limiting organic heart disease; mild diabetes, essential hypertension, or anemia. Patients with extreme obesity and chronic bronchitis may be included in this category.
Class III / A patient with severe systemic disease with definite functional limitations. Examples: severely limiting organic heart disease; severe diabetes with vascular complications; moderate to severe degrees of pulmonary insufficiency; angina pectoris, or healed myocardial infarction.
Class IV / A patient with severe systemic disease that is a constant threat to life. Example: Patients with organic heart disease showing marked signs of cardiac insufficiency, persistent anginal syndrome, or active myocarditis; advanced degrees of pulmonary, hepatic, renal, or endocrine insufficiency.
Class V / A moribund patient who is not expected to survive with or without the operation. Example: burst abdominal aneurysm with profound shock; major cerebral trauma with rapidly increasing intracranial pressure; massive pulmonary embolus. Most of these patients require operation as a resuscitative measure.

C. GOALS OF SEDATION/ANALGESIA

  1. Guard the patient’s safety and welfare
  2. Minimize physical discomfort or pain
  3. To allay the anxiety and fear of the patient, thus ensuring an accepting/cooperative patient.
  4. Control behavior
  5. Return the patient to a state in which safe discharge is possible.
D. MODERATE AND DEEP SEDATION/ANALGESIA
Involves the administration of pharmacological agents to predictably achieve desired levels of sedation, and monitoring patients carefully in order to maintain them at the desired level of sedation.
  1. Pre-Assessment for Moderate or Deep Sedation/Analgesia and Plan of Care

A pre-sedation assessment will be performed and documented for each patient before moderate or deep sedation use. The pre-sedation should collect information needed to:

  • Select and plan sedation (moderate or deep sedation)
  • Safely administer moderate or deep sedation, and
  • Interpret findings of patient monitoring

Physician Responsibilities include:

a.) Documentation of a baseline health assessment is to include but not limited to:

  1. Vital signs
  2. Results of labs/x-rays ordered
  3. Results of consultations, when ordered
  4. Health history including:
  • Age of the patient
  • Allergies
  • Previous adverse drug responses with anesthesia and/or sedation
  • Current medications
  • Review of systems
  • Diseases, disorders, abnormalities,
  • Prior hospitalizations
  1. Results of physical exam reflecting:
  • Height and weight
  • Baseline vital signs
  • Pulmonary and cardiac examination, and
  • Risk assessment including ASA classification
  • Patent airway
  1. Pregnancy status (if warranted);
  1. Informed consent(s) (for procedure and for sedation/analgesia)
  1. ASA status(See Table 1)
  1. Attest that the patient is a candidate for the planned sedation/analgesia

The RN will:

  • Conduct the pre-sedation/procedure assessment to include,
  • NPO status, time of last food and fluid intake;
  • Current blood pressure, pulse and respirations, oxygen saturation;
  • Level of consciousness / sedation status; (Baseline Ramsay)
  • Pain level and goal;
  • Pulse oximeter value on room air

In addition, the RN should:

  • Verify that the medical record contains evidence of:
  • Informed consent(s), and
  • An H&P
  • Establish intravenous access;
  • Document the patient pain goal and level of pain
  • Individualize and prioritize the nursing plan of care; and
  • Document baseline vital signs on the Sedation/Analgesia Flowsheet taken immediately prior to sedation/analgesia use.

b.) The pre-sedation and pre-procedureplan of care will be developed by the physician and documented in the patient’s medical record. The RN individualizes and prioritizes the patient’s nursing care needs and documents the findings on the Sedation/Analgesia Flowsheet. The patient’s plan of care is communicated among care provider.

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2.Personnel

a.) Staffing Protocol

Moderate sedation/analgesia. The minimum number of personnel involved in the care of a patient undergoing moderate sedation/analgesia during the entire procedure shall be two (2). The personnel shall consist of the Physician who performs the procedure and the Registered Nurse. The Registered Nurse’s sole responsibility during the performance of the procedure is to monitor the patient, the patient’s response to both the medications administered, and the procedure. In addition, the Registered Nurse is capable of assisting with any supportive or resuscitative measures.