Moderate Sedation- What Is It? Objectives

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1 Objectives Upon completion of this presentation, the learner will: Recognize indications and contraindication for moderate sedation. State appropriate monitoring techniques and safety requirements for patients undergoing moderate sedation. Identify medications frequently used for moderate sedation, administration guidelines, and management of potential complications/side-effects. Review issues that are under discussion within professional groups Review future trends in moderate sedation medications and administration Why do we need to know this stuff? Regulatory Agencies Sedation and analgesia may easily convert to deep sedation. Sedation and analgesia require constant monitoring of the patient. The ability to recognize and intervene in the event complications are essential skills for the RN and can determine positive patient outcomes. Regulatory Agencies State Boards of Nursing Professional Nursing Organizations The Joint Commission (TJC) Facility or Institutional Moderate Sedation- What Is It? History of Inadequate Treatment Brutane, until recently, was the analgesic and sedative most often used. What was Brutane, you may ask? Total immobilization by several adults to papoose the patient via brute strength. Paris PM. Amer J Emerg Med

2 Moderate Sedation-What Is It? Moderate* sedation refers to the practice of administering drugs for specific goals: Provision of safe analgesia, anxiolysis, and amnesia during stressful procedures. Safely decrease adverse psychological responses associated with stressful procedures. The return of patients to their pre-procedural level of functioning. *Formerly IV or conscious sedation When Do Standards For Moderate Sedation Apply? Generally, standards for moderate sedation apply when the practitioner responsible for overall conduct of procedural sedation is not a specialist in anesthesia. Common Clinical Settings Using Sedation RN Competencies Clinical Settings Gastroenterology Cardiology Procedures Colonoscopy, other gastrointestinal endoscopies Cardiac catheterization, Angiography, TEE, Angioplasty, Cardioversion, Pacemaker Est. # of Procedures (US, 2003) 24 million 12 million The registered nurse or other qualified staff responsible for monitoring the patient receiving moderate sedation is qualified by: Successful completion of an BLS/ACLS/PALS training course. Knowledge of A & P of the respiratory and cardiovascular systems. Cardiac arrhythmia recognition. Minor Surgery Knee arthroscopy, Inguinal hernia repair, Suturing, Excision of skin lesion or tumor, Dermatological surgeries, Insertion of lines/ catheters, trachs, PEG tubes, Biopsy (breast and liver) 12 million Pharmacology of analgesic, sedative and resuscitation drugs. Source: NDC; Verispan, Guilford Pharmaceuticals RN Competencies Ability to recognize and intervene in the event complications, adverse reactions or undesired outcome. Ability to rescue patients from deep sedation. Is competent to provide adequate oxygenation and ventilation via head-tilt or chin-lift maneuver, nasal airways, and bagvalve-mask. Pre-Sedation Assessment The independent practitioner responsible for performing the procedure needing the moderate sedation is generally required, within 30 days prior to procedural sedation, to: Perform a history and physical exam Assign an American Society of Anesthesiologist (ASA) health class Document a sedation plan (IV sedation, MAC, General) Document interval changes if H&P not done immediately prior to procedure. This is to be available on the chart prior to sedation administration! (TJC, 2012 Standards) 2

3 Pre-sedation Risk Assessment Mnemonic AMPLE Allergies Medications Past Medical History Last Meal Events leading up to the need for sedation Focused History Cardiopulmonary disease Hepatic or renal abnormalities Medications Patient allergies Substance abuse Tobacco Prior reactions Patient and Family Education Education, individually geared to the patient and family, helps alleviate concerns associated with moderate sedation. Duration of sedation Individual variability of response to drugs Potential for sedation failure Alternatives to sedation Potential for adverse events Plan for monitoring by a nurse during the procedure Discharge criteria. Airway Assessment The patient undergoing moderate sedation should have an airway assessment. It may include: Airway class (Mallampati score) Mouth opening (patient should be able to open their mouth more than thee fingers breadths) Thyromental distance (distance from chin to thyroid, less than four fingerbreadths indicates potential difficult airway) Range of motion of the neck Mallampati Class 1 airway. Mallampati Class 4 airway Mallampati Class Airway Assessment, con t This image is representative of a short thyromental distance. May indicate difficulty in tracheal intubation. May also indicate possible difficulty establishing a satisfactory mask seal. 3

4 Indications for Anesthesia Provided Care American Association of Anesthesiologists ASA Risk Classification Long Procedures Airway difficulties Anatomic abnormalities Mouth Neck Jaw Prior failed IV sedation Age extremes Drug/Alcohol abuse Uncooperative or agitated patients ASA III or above Pregnancy Hx. of reactive airway ASA I ASA II ASA III ASA IV ASA V A healthy patient A patient with mild systemic disease A patient with severe systemic disease (limits activity but not incapacitating) A patient with an incapacitating systemic disease that is a constant threat to life A moribund patient not expected to survive 24 hours with or without surgery (Approved by the ASA House of Delegates on October 27, 2004, and amended on October 21, 2009) Goals for Sedation Minimal Sedation (Anxiolysis) Sedation where the patient responds normally. The administration of oral medications for the reduction of anxiety. Respirations and eye movements are normal. Protective reflexes are intact. Amnesia may or may not be present. Goals for Sedation Moderate sedation/analgesia A medically controlled state of depressed consciousness. Protective reflexes are intact. Patient maintains airway independently and continuously. Responds appropriately to physical stimulation or verbal command. Levels We Try To Avoid Deep sedation/analgesia Depressed consciousness from which the patient is not easily aroused. May have partial or complete loss of protective reflexes. May not be able to maintain airway independently. Responds purposefully to repeated or painful stimulation. Levels We Avoid Anesthesia-General A medically controlled state of unconsciousness from which patients cannot be aroused, even by painful stimuli. Partial or complete loss of protective reflexes. Usually will require airway support. May compromise cardiovascular system. 4

5 Sedation, Analgesia, or Neither? The Spectrum of Sedation Patients may travel quickly in either direction along this spectrum! Level of Consciousness Awake Analgesia Anxiolysis Hypnosis Moderate Sedation Deep Sedation General Anesthesia Sweet Spot Protective Reflexes Present Present Potential Loss Potential Loss Total Loss Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/ Analgesia ( Responsiveness Airway Spontaneous Ventilation Cardiovascular Function Minimal Sedation Anxiolysis Normal response to verbal stimulation Unaffected Moderate Sedation Purposeful* response to verbal or tactile stimulation No intervention required Deep Sedation Purposeful* response following repeated or painful stimulation Intervention may be required Unaffected Adequate May be inadequate General Anesthesia Unarousable, even with painful stimulus Intervention often required Frequently inadequate Unaffected Usually maintained Usually maintained May be impaired * Reflex withdrawal from a painful stimulus is NOT considered a purposeful response Sedation Endpoints The ideal sedation endpoint would be one at which the procedure can be successfully accomplished with as little distress to the patient as possible and with cardiopulmonary stability and retention of protective airway reflexes. Clinical Sedation Endpoints Each patient is different but endpoints for moderate sedation may include : Slurred speech Drowsiness Respirations / minute Points To Consider Drugs should allow a patient to be calm, comfortable and cooperative. A drug should be allowed to exert its full effect before giving additional doses or another drug. Nystagmus (may be normal with large doses of diazepam) 5

6 Drug Selection For Moderate Sedation Narcotics/Opioids Have both sedative and analgesic qualities. Sedatives/Benzodiazepines (BZD) Anxiolysis, but no analgesia. Hypnotics/Dissociatives Provide sedation, analgesia, anesthesia Narcotic/Opioids Opioids are primarily metabolized in the liver, but some active metabolites are excreted via the kidneys. True allergic reactions are fairly rare. Common Drugs used for Sedation: Demerol, Fentanyl, Remifentanyl Narcotic/Opioids Side Effects Nausea Feeling of body warmth Heaviness of extremities Dry mouth Pruritis Contraindications Asthma Emphysema Severe obesity Epilepsy DTs Onset: minutes Duration: 2-4 hours Dose: mg IV bolus. Additional doses may be given at 5-20 minute intervals Meperidine Interactions: Alcohol Barbiturates Phenothiazines Anxiolytics Adverse effects: Respiratory depression Apnea Seizure (due to the metabolite normeperidine) Meperidine: Special Considerations Use cautiously in patients with renal/hepatic disease and in those with little cardiac reserve. Meperidine + MAO inhibitors = Seizures Elderly patients are often more sensitive to the effects of opioids. Pediatric patients exhibit increased sensitivity to opioids because of immature blood-brain barrier and renal function. Fentanyl Potent synthetic opiate agonist. Structurally similar to meperidine. May be administered alone or in combination with benzodiazepines. May result in Rigid Chest Syndrome. 6

7 Fentanyl Initial dose: mcg Additional doses: doses of 25 mcg can be administered every 2-5 minutes until adequate sedation is achieved Onset of action: 1-2 minutes Peak effect: 3-5 minutes Duration of effect: minutes A dose reduction of up to 50% may be indicated for the elderly. Benzodiazepines (BZD) This class of drugs provides sedation, amnesia, anxiolysis, and even anticonvulsant properties. Benzodiazepines include the drugs midazolam, diazepam, lorazepam, and alprazolam. But NO analgesia properties! Benzodiazepines: Special Considerations BZDs may cause dose-related respiratory depression, hypotension, and tachycardia, particularly in the elderly. Midazolam administered rapidly has been noted to produce apnea. BZDs are generally contraindicated in pregnancy. Diazepam may cause thrombophlebitis. Midazolam Midazolam is a short-acting benzodiazepine (BZD) and produces a dose-dependent sedation, hypnosis, skeletal muscle relaxation, and anticonvulsant activity. Initial dose: 1-2 mg Additional doses: 1 mg at 2-minute intervals Onset of action: 1-2 minutes Peak effect: 3-4 minutes Duration of effect: minutes Midazolam and Diazepam Clinical Pharmacology (as originally introduced into clinical practice) Onset Elimination Half-Life Duration Equipotent Doses Diazepam "slow" 40 hr "long" 10 mg Midazolam "fast" 4 hr "short" 5 mg Sedative Dose (mg) Midazolam Sedation Age (years) Highest Range: 7-13 mg Lowest Range: 2-3 mg Adapted from Bell, J Clin Pharmacol 1987 Feb;23(2):

8 Precedex Selective alpha2-adrenergic agonist-sedative Administered only by persons skilled in management of patients in the intensive care or operating/procedural room setting. Moderate decreases in heart rate and blood pressure should be expected. Requires continuous monitoring Dosing: 1 mcg/kg IV load over 10 minutes followed by 0.2 mcg/kg/hr infusion. Etomidate Ultrashort-acting nonbarbiturate hypnotic Has been associated with nausea, vomiting, myoclonus, seizures, pain at injection s local and thrombophlebitis. Dosing: 0.2 to 0.6 mg/kg IV over seconds Maintenance: 5-20 mcg/kg/min Onset: seconds Peak: 1 minute Duration: 3-5 min Flumazenil Flumazenil reverses BZD sedation, respiratory depression & paradoxical agitation. Half-life is only ~45 min. Monitoring required for 1-2 hrs. after last dose of flumazenil. May precipitate seizures in patients with underlying disorder. Flumazenil Dosing 0.2 mg IV over 15 seconds (Up to 4 additional doses of 0.2 mg can be administered at 60 second intervals) Onset: 1-2 minutes Peak: 3-5 minutes Duration of effect: minutes If re-sedation occurs, repeated doses can be administered at 20 minute intervals. Maximum single dose 1 mg Maximum hourly dose 3 mg Naloxone Opioid antagonist which binds to CNS receptors, displacing opioid agonists. Reverses respiratory depression and sedation associated with opioids. Over-administration may result in tachycardia, hypertension, severe pain, nausea & vomiting, and pulmonary edema. Naloxone Dosing Initial dose: mg Additional doses: mg IV every 2-3 minutes until desired response is attained. Supplemental dose may be necessary after minutes. Onset of action: 1-2 minutes Peak effect: 5 minutes Duration of effect: minutes 8

9 Naloxone: Special Considerations Patients receiving naloxone will require a longer period of monitoring to watch for recurrent respiratory depression. Monitor for one hour after last dose of naloxone. Naloxone may cause severe pain if entire analgesic effect of narcotics is reversed. Sedation & Breastfeeding: Special Considerations It is generally not necessary for health care professionals to advise mothers to discontinue breastfeeding or to "pump and dump" for surgical or diagnostic procedures requiring oral, inhalation or intravenous sedation because most medications used are compatible with breastfeeding. Should consider avoiding diazepam and morphine as sedative agents for a surgical or diagnostic procedure because of their long half life and higher milk to plasma ratio. If cautious, advise pump and dump for 4 hours after sedation. (Ting, 2001) Reversal Agents for Opioids and Benzodiazepines Drug Pediatric Adult Onset Peak Duration Naloxone (opioid reversal) Flumazenil Benzodiazepine reversal 0.01 mg/kg for children < 20 Kg 0.01 mg/kg for children < 20 Kg mg < 2 minutes 5-15 minutes minutes 0.1 mg increments 1 3 minutes 6-10 minutes < 60 minutes Now that you ve got them sedated Notes of Caution: For inadequate ventilation, start with naloxone at the low end of the dosing scale. For apnea, start with 0.1 mg increments. Higher doses of naloxone may also reverse the analgesia, leading to an increase in pain, hypertension, and/or nausea. Rapid injection of naloxone may result in pulmonary hypertension in susceptible individuals. Naloxone is supplied in multiple strengths Read label carefully and remember that diluting it (0.9% Normal Saline) may give you better control of small doses. The duration of action for both agents is SHORTER than the drugs they are reversing, repeat doses may be needed and patients should be held and monitored for an appropriate length of time to assure re-sedation does not occur. Why Monitor? Cardiopulmonary complications account for >50% of all sedation complications. Combination agents (e.g. benzodiazepines and opiates) potentiate effect and risk of complications. Sedation Equipment Mnemonic SOAP ME Suction Oxygen Airway Pharmacy Monitors Equipment 9

10 Monitoring & Equipment Pulse oximeter (finger, ear, temporal) B/P machine or manometer, cuffs, Stethoscope EKG monitor Source of oxygen & suction Suction catheters Nasal cannula, simple face masks, & blow-by sets for oxygen delivery Required Monitoring Continuous: O2 Saturation Cardiac Record at designated intervals per your institution's protocol, but no less than every 15 minutes Interval: Blood Pressure / Respirations Record at designated intervals per your institution's protocol, but no less than every 15 minutes Respirations Baseline assessment made & recorded prior to administration of drugs Record rate every 5-15 minutes thereafter. Observe for adequacy of spontaneous ventilation/airway patency. May utilize oximetry and capnometry as needed. Oxygen Levels Oxygen saturation (SpO 2 ) should be recorded prior to administration of supplemental oxygen & prior to initiating sedation. Oxygen should be immediately available to all patients undergoing moderate sedation. Begin at 2L/min via nasal cannula. Changes in rate/mode of oxygen delivery may be made based on patient response. B/P & Heart Rate Why ACLS is Required Baseline measurements and recordings are required. Assess & document 2-3 minutes after administration of any drug, when the patient s condition changes, and at minimum, every 15 minutes and/or per institution guidelines. EKG monitoring for all patients. Patients may require intervention if they experience serious changes in vital signs or EKG tracing as they undergo moderate sedation. 10

11 Level of Consciousness (LOC) Patient response should be assessed using the patient sedation scale and frequency template selected for use by your institution. Patients responding only to painful stimulation have moved into deep sedation and are at risk for airway compromise. Immediately stimulate patient to take a deep breath. May require physical as well as verbal stimulation. Ideally, anesthesia providers should be available to provide Airway and/or hemodynamic support as necessary. Level of Sedation Sedation Score 0 Sedation Score 1 Fully awake Light sedation, largely aware of self/surroundings. Mildly sleepy. Sedation Score 2 Moderate sedation, slightly aware of self/surroundings; somnolent but easily aroused with stimulation. Sedation Score 3 Deeply sedated; unaware of self/surroundings. Sedation Score 4 General anesthesia; patient is unconscious. Alternate Sedation Scales Richmond Agitation Sedation Scale (RASS) Pasero Opioid-Induced Sedation Scale (POSS) University of Michigan Sedation Scale (UMSS) Ramsey Sedation Score (RSS) Modified Ramsey Sedation Scale (MRSS) Motor Activity Assessment Scale (MAAS) Riker Sedation-Agitation Scale (SAS) Occasionally Patients who receive sedatives may become disinhibited and, at times uncooperative. If I just hadn t given that last dose. All sedation has the potential to cause unplanned deep sedation. When that happens providers may find themselves up to their bottom ends in alligators! Emergency Equipment A number of items must be immediately available & operational before undertaking procedural sedation. Supplemental monitors Basic & advanced airway management equipment IV supplies Emergency drugs / Crash Cart / Code Cart Defibrillator 11

12 Respiratory Support Initial interventions to establish a patent airway and improve oxygenation Open the airway with a head tilt / jaw thrust Airway Support Oral Airway Nasal Airway Types Placement Measurement Placement Berman Guedel Airway/Ventilation Intervention Other interventions to establish a patent airway and improve oxygenation Bag-valve mask device LMA Recovery & Discharge The nurse will assess the patient against the criteria. All criteria will be met prior to discharge. If criteria elements are not met, wriiten physician release is required prior to discharge. Up to 2 hours is required after the last administration of reversal agents to ensure patients do not become re-sedated after reversal has worn off. This may vary by institution. Know yours! Recovery & Discharge The recovery period lasts from the conclusion of the test/operative procedure until the patient has returned to baseline. Discharge instructions should be clearly written and reviewed with patient/responsible adult. Patients should not be returned to inpatient areas until they are capable of signaling for assistance if necessary. Discharge Criteria Potential areas of evaluation At minimum, a satisfactory return of presedation ² Activity / movement ² Minimal decrease in LOC ² Respirations ² Circulation Taking oral fluids; not vomiting Accompanied by a responsible adult 12

13 Foundations of Safe Sedation Questions, questions Monitoring Provider Education Rescue Skills Ketamine: For moderate Sedation? Propofol: Should nurses administer? CO 2 monitoring: Mandatory or not? COMPETENCY Ketamine Dissociative anesthetic Phencyclidine derivative (PCP) Provides analgesia and amnesia Usually administered by anesthesia provider Minimal effects on respiratory system Cardiovascular stimulant Dosing: IV to 2mg/kg Ketamine Contraindications: é Intracranial Pressure, é Intraocular Pressure, Procedures requiring complete immobility Onset of action IV 1-2 minute May cause nystagmus, vocalizations, and myoclonus. Ketamine produces heavy secretions; consider co-administration of glycopylorrate as a drying agent Ö Can cause larygospasms and hallucinogenic emergent reactions. Propofal Produces sedation, anesthesia and amnesia. Has respiratory and cardiovascular depressant effects, with minimal influence on heart rate. Anesthesia is immediate and short-lived. Cardiorespiratory depression, apnea and significant hypotension are dose-related. Dosing: 10 mg IV bolus followed by 5 mcg/kg/min infusion Onset: Average 30 seconds Duration: 3-10 minutes Why the Controversy? Strict product labeling Unpredictable and profound effects. No reversal agent. Financial incentives/disincentives Legal barriers Review regulations/position statements 13

14 So, for now The debate about who should be allowed to administer propofol will continue, but Whenever propofol is used for sedation, it should be administered only by persons who are: Trained in the administration of drugs that cause deep sedation and general anesthesia. Able to intubate the patient if necessary. Not involved simultaneously in the procedure itself. Capnography Capnography the measurement of carbon dioxide (CO2) in exhaled breath. Capnography will show immediate apnea, while pulse oximetry will show a high saturation for several minutes Why Capnography? Signals gas exchange problems faster than SaO 2 Caveats Increase in O 2 does not automatically decrease CO 2 To affect exchange process, may need to reverse sedation May need to assist ventilation Salter cannulas may be used to simultaneously administer O 2 and monitor CO 2 in a patient who is breathing spontaneously. This produces an observable capnograph that will disappear in the face of apnea or disconnection/ obstruction of the cannula CO 2 Monitoring O 2 is delivered to one nare Salter Eyes Is Capnography Mandatory? At this time Maybe??? Permanent Barrier while CO 2 is sampled from the other nare. 14

15 ASA Standards, Effective July 2011 During moderate or deep sedation the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs and monitoring for the presence of exhaled carbon dioxide unless precluded or invalidated by the nature of the patient, procedure, or equipment." The intent is that during moderate or deep sedation (regardless of location), the adequacy of ventilation be evaluated by both continual observation of qualitative clinical signs and by monitoring for the presence of exhaled carbon dioxide. Centers for Medicare and Medicaid Services (CMS) CMS does not require a facility to adhere to specialty regulations. However, there appears to be a de novo (anew, re-looked at) requirement by CMS that all anesthetic care must be rendered to the same standard within one hospital, no matter in what location or by what practitioner. Moderate sedation that is carefully planned and carried out by a thoughtful, well-trained health care team will allow both caregivers and patients to have a positive experience rather than a bad memory. Conclusion Sandra Gardner pacurn75@ymail.com References American Society of Anesthesiologists. ASA Physical Status Classification System. Available at American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists, Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists. (2002) Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists: An updated report, Anesthesiology report, Anesthesiology, 96(4), References Halliday AB. Shades of sedation: learning about moderate sedation and analgesia. Nursing. 2006;36(4): Holder, A., & Lorenzo, P. (2010). Sedation. emedicine Specialties. Retrieved August 10, 2010 from Odom-Forren J. The evolution of nurse-monitored sedation. J Perianesth Nurs. 2005;20(6):

16 References Ting, P.H. (2001). Breastfeeding and Anesthesia. Anesthesiology INFO. Retrieved October 7, 2011 from 16