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Alex Y. Bekker, MD, PhD Associate Professor of Anesthesiology and Neurosurgery

Dexmedetomidine for Monitored Anesthesia Care (MAC). Alex Y. Bekker, MD, PhD Associate Professor of Anesthesiology and Neurosurgery New York University Medical Center New York, New York.

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Alex Y. Bekker, MD, PhD Associate Professor of Anesthesiology and Neurosurgery

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  1. Dexmedetomidine for Monitored Anesthesia Care (MAC) Alex Y. Bekker, MD, PhD Associate Professor of Anesthesiology and Neurosurgery New York University Medical Center New York, New York

  2. “We have completed our review of this application, as amended, and it is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.”

  3. Monitored Anesthesia Care: Definition Monitored Anesthesia Care (MAC) may include varying levels of sedation, analgesia, and anxiolysis as necessary. The provider of MAC must be prepared and qualified to convert to general anesthesia when necessary. Position on Monitored Anesthesia Care, ASA 2005

  4. Continuum of Depth of Sedation Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists, Anesthesiology 2002

  5. * * * % of claims in anesthesia group * * P<.025 MAC versus Regional Injury and Liability Associated with Monitored Anesthesia Care • Bhananker and colleagues assessed the patterns of injury and liability associated with monitored anesthesia care (MAC; n = 121) as compared with general (n = 1519) and regional anesthesia (n = 312) Bhananker S, Anesthesiology 2006

  6. Injury Associated with MAC N=121 % Respiratory event 24 Cardiovascular event 14 Equipment failure/malfunctioning 21 Related to regional block 2 Inadequate anesthesia/patient movement 11 Medication related 9 Other events 20 Bhananker S, Anesthesiology 2006

  7. Characteristics of an Ideal Sedative • Cooperative sedation • Minimal depression of ventilation • Hemodynamic stability • Analgesic effects • Wide therapeutic window • Minimal risks of side effects • Favorable pharmacodynamic/ pharmacokinetic profile • Amnesia (?)

  8. Study Design: Monitored Anesthesia Care 325 Patients: 260 Dex; 65 Placebo receiving MAC for surgical procedures; 25 US sites 2 Precedex Arms: 0.5 mcg/kg/10 min load or 1.0 mcg/kg/10 min load; 0.6 mcg/kg/hr maintenance titrated 0.2 – 1.0 mcg/kg/hr. OAA/S Scale: Midazolam rescue for > 4. Primary Endpoint: % of pts not requiring MDZ based on OAA/S. Secondary Endpoints: total MDZ, fentanyl, sedation failures; pt satisfaction; anesthesiologist assessment; PONV Safety: respiratory depression; hemodynamic stability

  9. MAC Primary EfficacyRequirement of Rescue Midazolam (MDZ)

  10. MAC Secondary EfficacyAnesthesiologist Assessment

  11. MAC Secondary EfficacySubject Assessment

  12. Overview of Awake Fiberoptic Intubation Trial • Double-blind, randomized, placebo-controlled • 100 patients: 50 Precedex; 50 Placebo; 18 US sites • Precedex: 1.0 mcg/kg/10 min; 0.7 mcg/kg/hr maint • Rescue is Midazolam(0.5 mg doses) based on Ramsay Sedation Scale of 1. • Primary Endpoint: % of patients requiring Midazolam • Secondary Endpoints: Total MDZ dose; other rescue meds; patient satisfaction; anesthesiologist assessment • Safety Endpoints: hemodynamic stability; respiratory depression

  13. AWAKE Primary EfficacyRequirement of Rescue Midazolam (MDZ)

  14. In cooperative sedation, patients easily transition from sleep to wakefulness and task performance when aroused Patients are able to resume rest when not stimulated Cooperative sedation is most useful during procedures in which communication with the patient must be maintained Facilitates participation in therapeutic maneuvers Allows for patient interaction in care decisions May contribute to shorter recovery room convalescence Reduces risk of developing drug-induced complications Characteristics of Cooperative Sedation

  15. “The brain is not a sausage, it’s more like a well tuned musical instrument” Rudolfo Llinas Endogenous sleep Loss of response to external stimuli Sedative component of anesthesia

  16. Arousability From Sedation During Dexmedetomidine Infusion • Patients were infused with placebo or 1 of 2 doses of dexmedetomidine and monitored with the Bispectral Index System (BIS) before stimulation and immediately after being asked to perform cognitive and cold pressor tests • Patients receiving either infusion of dexmedetomidine could be completely aroused by a mild stimulus1 Just prior to cognitive and cold pressor testing During cognitive and cold pressor testing Dexmedetomidine Infusion (mcg/kg/h) BIS indicates Bispectral Index System Hall JE, Anesth Analg 2000

  17. Dexmedetomidine in Carotid Endarterectomy • Avoid oversedation • Reduce anxiety • Maintain communication • Minimize respiratory depression

  18. Intraoperative Assessment of Sedation Level by the Blinded Observer Bekker A , J Neurosurg Anesth 2004

  19. The Safety of Dexmedetomidine as Primary Sedative for Awake CEA Total number of patients N=151 General Anesthesia N=10 Regional/Dex N=123 Regional/No Dex N=18 No Shunt N=0 Shunt N=10 No Shunt N=111 Shunt N=12 No Shunt N=12 Shunt N=6 Elective N=10 Obligatory N=0 Elective N=7 Obligatory N=5 Elective N=4 Obligatory N=2 Bekker A, Anesth Analg 2006

  20. Clinical Experience with Dexmedetomidine for DBS Implantation • Dex (0.3-0.6 mcg/kg/hr) did not impair intensity of movement disorder or interfere with MER in PD patients • Titration of Dex provided satisfactory sedation for DBS implantation • Dex provided HD stability and decreased the use of antihypertensives1 • Propofol induced dyskinesia was controlled with DEX during DBS placement2 1Rozet I, Anesth Analg 2006. 2 Deogaonkar A , Anesthesiology 2006.

  21. Dexmedetomidine and Respiratory Depression • Minimal effects on ventilation is well documented in human volunteers 1 • Lack of respiratory depression was demonstrated in ICU patients 2 1Belleville JP, Anesthesiology, 1992; Ebert TJ, Anesthesiology, 2000. 2 Venn RM, Crit Care , 2000; Martin E, J Intensive Care Med 2004.

  22. Hospira MAC Trial: Respiratory Depression Definition of Respiratory Depression: Respiratory rate < 8 bpm or oxygen saturation < 90% Dex 0.5 Dex 1.0 Pcb 5 (3.7%) 3 (2.3%) 8 (12.7%) P<0.018 Both Dex groups: neither respiratory depression nor intervention Plb group: respiratory depression or a need for intervention 13.1% and 16.1% respectively

  23. Dexmedetomidine and Hemodynamic Stability Arain SR, Anesth Analg 2002 Bekker A, J NeurosurgAnesth2004

  24. MAC Trial: Mean Changes in Systolic and Diastolic Blood Pressure and Heart Rate

  25. Postoperative Effects of Dexmedetomidine 100 Propofol Dexmedetomidine 40 30 Improved postoperative pain and greater sedation with dexmedetomidine compared with propofol VAS Pain Less Pain More Pain 20 * † 10 0 100 * † 80 Less Alert More Alert VAS Sedation 60 40 0 Pre- surg 5 35 50 65 Surg End 20 Time After Surgery, minutes *P<.05 difference over time compared with baseline †P<.05 difference between groups • Arain SR, Anesth Analg, 2002

  26. Morphine Dexmedetomidine P<.01 Morphine-Sparing Effects in Inpatient Surgery • 34 patients scheduled for inpatient surgery • Randomized to either dexmedetomidine or morphine • Agents were started 30 minutes before the end of surgery • Dexmedetomidine reduced the early postoperative need for morphine by 66% P<.01 • Arain SR, Anesth Analg 2004

  27. MAC Trial: Fentanyl Use

  28. Pharmacokinetics of IV agents

  29. Dexmedetomodine Was Tried as a Primary Sedative for: • Sedation in CT and MRI imaging studies Mason K, Ped Anesth 2008 Koroglu A, Anesth Analg 2006 • Outpatient third molar surgery Ustin Y, J Oral Maxilfac Surg 2006 Cheung C, Anaesthesia 2007 • Cataract surgery Alhashemi J, Br J Anaest 2006 • Cardiac catheterization Tosun Z, J Card Vasc Anesth 2006 Mester R, Am J Therap 2008

  30. Use of Dexmedetomidine in MRI • 80 children aged 1-7 years • Randomly assigned to either dexmedetomidine or midazolam • 10-minute loading doses: 1 mcg/kg dexmedetomidine, 0.2 mg/kg midazolam • Infusions: 0.5 mcg/kg/h dexmedetomidine, 6 mcg/kg/h midazolam1 • The quality of MRI was significantly better (P<.001) and the rate of adequate sedation was significantly higher (P<.001) with dexmedetomidine Quality of MRI * 1 = no motion 2 = minor movement 3 = major movement necessitating another scan * *P<.001 compared with midazolam • Koroglu A, Br J Anaesth 2005

  31. Dexmedetomidine for GI Procedures Jalowiecki P, Anesthesiology 2005 Use of Dex was associated with bradycardia, hypotension, vertigo, nausea/vomiting, prolonged recovery Muller R, Gastroint Endosc 2008 Clinical efficacy of Dex alone is less than propofol during ERCP Demiraran Y, Can J Gastroenter 2007 Dex may be a good alternative to midazolam for upper endoscopy

  32. Dexmedetomidine: Safety Propofol TI = 3.5 Harrison N, Anesthetic Pharmacology, 2004 Dexmedetomidine: Jorden V, Ann Pharmacoth, 2004 Pt 1 - 60 times the prescribed dose Pt 2 - 10 times the prescribed dose Pt 3 - 60 times the prescribed dose Ramsay M, Anesthesiology, 2004 Pt 1 - Infusion rate 10 mcg/kg/h Pt 2 - Infusion rate 5 mcg/kg/h Pt 3 – Infision rate 5 mcg/kg/h Therapeutic Index = (median lethal dose [LD50] / (mean effective dose [ED50]

  33. Comparison of Clinical Effects

  34. Comparison of Adverse Effects

  35. All progress is based upon a universal innate desire on the part of every organism to live beyond its income

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