1. Moderate Sedation/ Analgesia (Conscious Sedation) Anuradha Patel M.B.B.S., M.D., D.A., F.R.C.A. ( I ), D.A.B.A. Assistant Professor, Department of Anesthesiology and Perioperative Medicine UMDNJ, Newark

2. Introduction These guidelines are designed to be applicable to procedures performed in a variety of settings by practitioners who are not specialists in anesthesiology.The purpose of these is to allow clinicians to provide their patients with the benefits of sedation /analgesia, while minimizing associated risks.These guidelines are intended to be general in their application and broad in scope. These guidelines are designed to be applicable to procedures performed in a variety of settings by practitioners who are not specialists in anesthesiology.The purpose of these is to allow clinicians to provide their patients with the benefits of sedation /analgesia, while minimizing associated risks.These guidelines are intended to be general in their application and broad in scope.

3. Depth of Sedation Minimal Sedation (Anxiolysis) Minimal Sedation (Anxiolysis) - is 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. - is 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.

4. Depth of Sedation Moderate Sedation/Analgesia (Conscious Sedation) - is 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.

5. Depth of Sedation Deep Sedation/Analgesia Deep Sedation/Analgesia - is drug induced loss of consciousness during which patients cannot be easily aroused but respond purposefully* following repeated stimulation. The ability to independently maintain ventilatory function is often impaired.Patients may require assistance in maintaining a patent airway and positive pressure ventilation may be required. Cardiovascular function may be impaired. - is drug induced loss of consciousness during which patients cannot be easily aroused but respond purposefully* following repeated stimulation. The ability to independently maintain ventilatory function is often impaired.Patients may require assistance in maintaining a patent airway and positive pressure ventilation may be required. Cardiovascular function may be impaired.

6. Depth of Sedation General 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 is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required. Cardiovascular function may be impaired.

7. Depth of Sedation Protective airway reflexes -includes the ability of an individual to counteract noxious events, especially to defend breathing passages against foreign material. Protective airway reflexes -includes the ability of an individual to counteract noxious events, especially to defend breathing passages against foreign material. Reflex withdrawal from a painful stimulus is NOT considered a purposeful response Reflex withdrawal from a painful stimulus is NOT considered a purposeful response Sedation is a continuum, it is not always possible to predict how an individual will respond. Sedation is a continuum, it is not always possible to predict how an individual will respond. Practitioners intending to produce a given level of sedation should be able to rescue patients whose level of sedation becomes deeper than initially intended. Practitioners intending to produce a given level of sedation should be able to rescue patients whose level of sedation becomes deeper than initially intended.

8. Locations of M.S./Analgesia Radiology Department Radiology Department Medical Special Procedures Medical Special Procedures Dental Clinic Dental Clinic Emergency Department Emergency Department Progressive Care Units Progressive Care Units Procedure Unit E- Yellow Procedure Unit E- Yellow Critical Care Units Critical Care Units Echocardiology Lab Echocardiology Lab Cardiac Catheterization Lab Cardiac Catheterization Lab Clinics (Audiology, Neurology) Clinics (Audiology, Neurology) Pre-operative holding area Pre-operative holding area

9. Patient Evaluation History/ Physical exam History/ Physical exam Airway evaluation Airway evaluation Abnormalities of the major organ systems Abnormalities of the major organ systems Previous adverse experience with sedation Previous adverse experience with sedation Drug allergies, current meds.,potential interaction Drug allergies, current meds.,potential interaction Focused physical exam- vital signs, auscultation of heart and lungs, evaluation of the airway Focused physical exam- vital signs, auscultation of heart and lungs, evaluation of the airway NPO status NPO status Lab data Lab data

10. Patient Evaluation Airway Evaluation Mallampati Classification Relates tongue size to pharyngeal size Performed with the patient in the sitting position, the head held in a neutral position, the mouth wide open, and the tongue protruding to the maximum May vary if the patient is in the supine position (instead of sitting) If the patients phonates, this falsely improves the view. If the patient arches his or her tongue, the uvula is falsely obscured.

11. Patient Evaluation Airway Evaluation Mallampati Classification Class I = visualization of the soft palate, fauces, uvula, anterior and posterior pillars. Class II = visualization of the soft palate, fauces and uvula. Class III = visualization of the soft palate and the base of the uvula. Class IV = soft palate is not visible at all.

12. ASA Physical Status Class I- normal, healthy Class I- normal, healthy Class II- mild systemic disease Class II- mild systemic disease Class III- severe systemic disease, e.g. HTN COPD, Class III- severe systemic disease, e.g. HTN COPD, Class IV-severe systemic disease that is a constant threat to life, e.g. unstable angina Class IV-severe systemic disease that is a constant threat to life, e.g. unstable angina Class V- moribund patient not expected to live with or without the procedure Class V- moribund patient not expected to live with or without the procedure

13. Patient Evaluation When an anesthesiologist or other specialist may be needed. ASA class III or higher ASA class III or higher Airway abnormalities Airway abnormalities Morbid obesity Morbid obesity Sleep apnea Sleep apnea Previously failed sedation Previously failed sedation Major allergy or anaphylactic reaction Major allergy or anaphylactic reaction Complex procedure Complex procedure Prolonged sedation needed Prolonged sedation needed New procedure New procedure Unusual position Unusual position Unusual location Unusual location

14. Pre procedure preparation Informed consent Informed consent Pre op fasting Pre op fasting – Clear liquids2h – Breast milk4h – Infant formula6h – Milk6h – Light meal6h

15. Equipment Self inflating bag and mask Self inflating bag and mask Oxygen – 2 outlets Oxygen – 2 outlets Suction ( working ) Suction ( working ) Pulse oximeter, ECG monitor, BP. Monitor Pulse oximeter, ECG monitor, BP. Monitor ? Capnometer ? Capnometer Pharmacologic antagonists Pharmacologic antagonists Emergency equipment – airway kit (age appropriate) crash cart, defibrillator Emergency equipment – airway kit (age appropriate) crash cart, defibrillator

16. Monitoring and Documentation Pre-procedure Pre-procedure -V.S., SpO 2 Procedure Procedure -Continuous SpO 2, E.C.G. -V.S. q 5 min. -L.O.C. q 5 min.(level of consciousness) Post Procedure Post Procedure -Continuous SpO 2, V.S. q 5 min. for 15 min., then q 15 min. until discharge criteria met

17. Personnel 1. The minimal number of available personnel should be two: The operator (performs procedure) The monitor (administers drugs, monitors airway and vital signs. The second individual may assist with minor interruptible tasks. The second individual may assist with minor interruptible tasks. Both personnel must be credentialed in Moderate Sedation/ Analgesia

18. Personnel Personnel who can administer Moderate Sedation/ Analgesia or monitor a patient, include: Personnel who can administer Moderate Sedation/ Analgesia or monitor a patient, include: - A physician, or dentist who has been credentialed - A physician, or dentist who has been credentialed Under the supervision of the above, the following persons may administer M.S. Under the supervision of the above, the following persons may administer M.S. - CRNA, or a student CRNA, - CRNA, or a student CRNA, - resident physician or resident dentist - resident physician or resident dentist -registered nurse, under special situations. -registered nurse, under special situations.

19. Training of Personnel Individuals responsible for patients should understand the pharmacology of agents used for sedation and antagonists for opiates and benzodiazepines. Individuals responsible for patients should understand the pharmacology of agents used for sedation and antagonists for opiates and benzodiazepines. Individuals monitoring patients should be able to recognize associated complications. Individuals monitoring patients should be able to recognize associated complications. One individual capable of estabilishing a patent airway and positive pressure ventilation should be present. One individual capable of estabilishing a patent airway and positive pressure ventilation should be present. All personnel must be ACLS certified. All personnel must be ACLS certified.

20. Discharge Criteria Patients will be discharged according to the Aldrete score. The patients must have a score of ten. Aldrete score is printed at the end of the Moderate sedation/Analgesia record Aldrete score is printed at the end of the Moderate sedation/Analgesia record Patients who receive reversal agents need to remain in the procedure area for at least one hour after the last dose.

21. Drugs Drugs commonly used for M.S. Meperidine (Demerol) Morphine Fentanyl (Sublimaze) Ketamine Diazepam (Valium) Midazolam (Versed) Droperidol (Inapsine) Phenobarbital Naloxone (Narcan) Flumazenil (Romazicon)

22. Drugs Drugs EXCLUDED for M.S./ Analgesia by non-anesthesia staff are: Drugs EXCLUDED for M.S./ Analgesia by non-anesthesia staff are: Sodium Thiopental Sodium Thiopental Propofol Propofol Brevital (metho hexital) Brevital (metho hexital) Etomidate Etomidate Sufentanil Sufentanil Remifentanil Remifentanil

23. Combinations of Drugs IV.drugs should be given in small, incremental doses, titrated to end points of analgesia/sedation. IV.drugs should be given in small, incremental doses, titrated to end points of analgesia/sedation. Allow time for onset before repeating Allow time for onset before repeating Benzo. and opiates have synergistic effects Benzo. and opiates have synergistic effects Non IV routes, eg. Oral,rectal,im.,tm.-allow adequate time for absorption. Repeat doses not recommended(unpredictable absorption) Non IV routes, eg. Oral,rectal,im.,tm.-allow adequate time for absorption. Repeat doses not recommended(unpredictable absorption)

24. Synergy Effects of Benzodiazepine and Opiate are additive (synergistic) Effects of Benzodiazepine and Opiate are additive (synergistic) For example, 2 mg. Midazolam or 10 mg. Morphine equals no apnea For example, 2 mg. Midazolam or 10 mg. Morphine equals no apnea 1 mg Midazolam plus 5 mg morphine equals apnea 1 mg Midazolam plus 5 mg morphine equals apnea

25. Basic Considerations Low cardiac output equals slow onset Low cardiac output equals slow onset Consider the age of the brain Consider the age of the brain Consider the physical condition of the patient Consider the physical condition of the patient What effect is desired? What effect is desired? Is post-procedure pain control needed? Is post-procedure pain control needed? When in trouble, back out When in trouble, back out Titrate drugs to effect, wait for onset. Titrate drugs to effect, wait for onset.

26. Reversal agents Specific antagonists, naloxone/flumazenil should be available Specific antagonists, naloxone/flumazenil should be available May be administered if apnea or hypoxemia develops, but routine use is strongly discouraged. May be administered if apnea or hypoxemia develops, but routine use is strongly discouraged. Patients need to be observed longer in recovery (at least 2 hrs.) if reversal agents are used. Patients need to be observed longer in recovery (at least 2 hrs.) if reversal agents are used.

27. Opiates Dose-dependent binding to opioid receptors (especially mu) leads to: Dose-dependent binding to opioid receptors (especially mu) leads to: – Analgesia – Sedation – Respiratory Depression Side effects: Side effects: – Nausea/vomiting – Miosis – Decreased Peristalsis

28. Morphine Average Dose:5-15 mg Average Dose:5-15 mg Incremental Dose:2.5 mg Incremental Dose:2.5 mg Time Between Doses:5-10 min Time Between Doses:5-10 min Onset Time:5-10 min Onset Time:5-10 min Duration of Effect: 3-4 hrs Duration of Effect: 3-4 hrs Paradoxical Reaction Paradoxical Reaction Pruritis Pruritis Anaphylactoid Reaction Anaphylactoid Reaction Active Metabolites Active Metabolites

29. Meperidine (Demerol) Average Dose:50-150 mg Average Dose:50-150 mg Incremental Dose:25 mg Incremental Dose:25 mg Time Between Doses:5 min Time Between Doses:5 min Onset Time:3-5 min Onset Time:3-5 min Duration of Effect: 2-3 hrs Duration of Effect: 2-3 hrs Caution: Not used with MAO Inhibitors, Antidepressants, Antiparkinsonian drugs Caution: Not used with MAO Inhibitors, Antidepressants, Antiparkinsonian drugs Remember “Libby Zion” Remember “Libby Zion” Active Metabolite can accumulate with renal dysfunction Active Metabolite can accumulate with renal dysfunction

30. Benzodiazepines Enhance GABA transmission in CNS Enhance GABA transmission in CNS Most are lipid soluble only (except midazolam) Most are lipid soluble only (except midazolam) Effects: Effects: – Amnesia – Anticonvulsant – Anxiolytic – Behavioral disinhibition – Muscle relaxant

31. Diazepam Average Dose:5-20 mg Average Dose:5-20 mg Incremental Dose:2.5 mg Incremental Dose:2.5 mg Time Between Doses:2-3 min Time Between Doses:2-3 min Onset Time:1-2 min Onset Time:1-2 min Duration of Effect: 0.5-2 hrs Duration of Effect: 0.5-2 hrs Several active metabolites prolong effects Several active metabolites prolong effects Elimination t 1/2 15-21 hrs Elimination t 1/2 15-21 hrs

32. Midazolam (Versed) Average Dose:1-5 mg Average Dose:1-5 mg Incremental Dose:0.5-1 mg Incremental Dose:0.5-1 mg Time Between Doses:3-5 min Time Between Doses:3-5 min Onset Time:3-5 min Onset Time:3-5 min Duration of Effect: 0.5-2 hrs Duration of Effect: 0.5-2 hrs Water and lipid soluble Water and lipid soluble Active metabolites, which are less potent Active metabolites, which are less potent Elimination t ½ ; 2-4 hrs Elimination t ½ ; 2-4 hrs

33. Diphenydramine Sedating antihistamine with anticholinergic properties Sedating antihistamine with anticholinergic properties PO/IV/IM PO/IV/IM Maximum sedative effect 1-3 hrs, duration; 4- 7 hrs Maximum sedative effect 1-3 hrs, duration; 4- 7 hrs Elimination t 1/2 : 2-8 hrs Elimination t 1/2 : 2-8 hrs

34. Fentanyl (Sublimaze) Average Dose:0.025-0.15 mg Average Dose:0.025-0.15 mg Incremental Dose:0.025 mg Incremental Dose:0.025 mg Time Between Doses:2-3 min Time Between Doses:2-3 min Onset Time:1-2 min Onset Time:1-2 min Duration of Effect: 0.5- 1 hrs Duration of Effect: 0.5- 1 hrs Elimination t 1/2 : 3.1-6.6 hrs Elimination t 1/2 : 3.1-6.6 hrs May cause muscle rigidity May cause muscle rigidity

35. Naloxone (Narcan) Reversal of opiates Reversal of opiates Side effects: Side effects: – Pain – Hypertension – Tachycardia – Ventricular dsyrhythmias – Pulmonary Edema – Re-narcotization –Delayed respiratory depression

36. Naloxone (Narcan) Average Dose:0.4 mg Average Dose:0.4 mg Incremental Dose:0.04 mg Incremental Dose:0.04 mg Time Between Doses:2-3 min Time Between Doses:2-3 min Onset Time:1-2 min Onset Time:1-2 min Duration of Effect: 0.5-1 hrs Duration of Effect: 0.5-1 hrs

37. Flumazenil (Romazicon) Average Dose:1 mg Average Dose:1 mg Incremental Dose:0.2 mg Incremental Dose:0.2 mg Time Between Doses:1 min Time Between Doses:1 min Onset Time:1-2 min Onset Time:1-2 min Duration of Effect: 0.5-1.5 hrs Duration of Effect: 0.5-1.5 hrs Resedation Resedation Seizures Seizures

38. Performance Improvement All departments are responsible for PI activities related to moderate sedation All departments are responsible for PI activities related to moderate sedation Data collection monthly, quarterly reporting of complications on 6 PI indicators Data collection monthly, quarterly reporting of complications on 6 PI indicators All complications must be reported to Department of Anesthesiology PI representative A copy of the record needs to be sent to Dr. A Patel All complications must be reported to Department of Anesthesiology PI representative A copy of the record needs to be sent to Dr. A Patel Moderate sedation data is presented at the Invasive Procedure Committee and Hospital PI committee Moderate sedation data is presented at the Invasive Procedure Committee and Hospital PI committee

39. P.I. Indicators Respiratory complications- need for oral airway, bag mask ventilation, intubation etc. Respiratory complications- need for oral airway, bag mask ventilation, intubation etc. Cardiovascular complications- hypotension, arrythmias, etc. Cardiovascular complications- hypotension, arrythmias, etc. Use of reversal drugs Use of reversal drugs Admission to hospital,if outpatient Admission to hospital,if outpatient Pre sedation evaluation done Pre sedation evaluation done Discharge criteria documented Discharge criteria documented