Study Results
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Basic Information
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COMPLETED
PHASE4
142 participants
INTERVENTIONAL
2012-08-31
2015-05-31
Brief Summary
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Detailed Description
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The placebo/dexmedetomidine will be loaded at 1 mcg/kg over 20 minutes and then a continuous infusion of 0.5 mcg/kg/h for the duration of the procedure.
Intraoperative analgesia will be provided with fentanyl and dilaudid per the anesthesia team.
Upon closure the study drug will be terminated. Patients will be followed up for 72 hours after surgery. Total opiate consumption and visual analogue scale ratings will be documented.
Intra and postoperative inotrope/pressor requirements will be recorded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Methadone and dexmedetomidine
Standard American Society of Anesthesiology monitors. Midazolam 1-2 mg for pre-operative sedation. Lidocaine 0.5-1 mg/kg with induction. Propofol 1-2 mg/kg with induction. Fentanyl 0.5-1 mcg/kg with induction. Rocuronium 0.5 -1 mg/kg with induction. Total intravenous anesthesia with propofol for maintainence of anesthesia. Titrated to maintain BIS (bispectral index) between 30-60.
Methadone 0.2 mg/kg ideal body weight and dexmedetomidine 1 mcg/kg load over 20 minutes followed by a continuous infusion of 0.5 mcg/kg/h for the duration of the procedure.
Dexmedetomidine
In the intervention arm dexmedetomidine at a dose of 1 mcg/kg over 20 mins followed by an infusion of 0.5 mcg/kg/h for the duration of the surgery.
Methadone and placebo
Standard American Society of Anesthesiology monitors. Midazolam 1-2 mg for pre-operative sedation. Lidocaine 0.5-1 mg/kg with induction. Propofol 1-2 mg/kg with induction. Fentanyl 0.5-1 mcg/kg with induction. Rocuronium 0.5 -1 mg/kg with induction. Total intravenous anesthesia with propofol for maintainence of anesthesia. Titrated to maintain BIS (bispectral index) between 30-60.
Methadone 0.2 mg/kg ideal body weight and placebo (normal saline) 1 mcg/kg load over 20 minutes followed by a continuous infusion of 0.5 mcg/kg/h for the duration of the procedure
No interventions assigned to this group
Interventions
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Dexmedetomidine
In the intervention arm dexmedetomidine at a dose of 1 mcg/kg over 20 mins followed by an infusion of 0.5 mcg/kg/h for the duration of the surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elective multi-level thoracic and/or lumbar spine surgery requiring SSEP, EMG or MEP monitoring
Exclusion Criteria
* Age \< 18 years
* Pregnant patients
* Advanced heart block: Mobitz type II block or atrio-ventricular dissociation in a previous EKG.
* Any individual with stage 4 or greater chronic kidney disease (eGFR\< 30 ml/min) and/or requiring dialysis or liver failure defined as a history of cirrhosis or fulminant hepatic failure
* Any individuals on preoperative methadone therapy
* Preoperative dexmedetomidine use
* Preoperative systolic hypertension defined by a systolic blood pressure greater than 150 mmHg in the surgical admission suite
* Enrolled in another study within 30 days
18 Years
80 Years
ALL
Yes
Sponsors
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University of Virginia
OTHER
Responsible Party
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Bhiken I. Naik, MD
Assistant Professor, Anesthesiology
Principal Investigators
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Bhiken Naik, MBBCh
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
Korkmaz Dilmen O, Tunali Y, Cakmakkaya OS, Yentur E, Tutuncu AC, Tureci E, Bahar M. Efficacy of intravenous paracetamol, metamizol and lornoxicam on postoperative pain and morphine consumption after lumbar disc surgery. Eur J Anaesthesiol. 2010 May;27(5):428-32. doi: 10.1097/EJA.0b013e32833731a4.
Khan ZH, Rahimi M, Makarem J, Khan RH. Optimal dose of pre-incision/post-incision gabapentin for pain relief following lumbar laminectomy: a randomized study. Acta Anaesthesiol Scand. 2011 Mar;55(3):306-12. doi: 10.1111/j.1399-6576.2010.02377.x.
Loftus RW, Yeager MP, Clark JA, Brown JR, Abdu WA, Sengupta DK, Beach ML. Intraoperative ketamine reduces perioperative opiate consumption in opiate-dependent patients with chronic back pain undergoing back surgery. Anesthesiology. 2010 Sep;113(3):639-46. doi: 10.1097/ALN.0b013e3181e90914.
Grewal A. Dexmedetomidine: New avenues. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):297-302. doi: 10.4103/0970-9185.83670. No abstract available.
Chan AK, Cheung CW, Chong YK. Alpha-2 agonists in acute pain management. Expert Opin Pharmacother. 2010 Dec;11(17):2849-68. doi: 10.1517/14656566.2010.511613. Epub 2010 Aug 13.
McQueen-Shadfar LA, Megalla SA, White WD, Olufolabi AJ, Jones CA, Habib AS. Impact of intraoperative dexmedetomidine on postoperative analgesia following gynecologic surgery. Curr Med Res Opin. 2011 Nov;27(11):2091-7. doi: 10.1185/03007995.2011.618491. Epub 2011 Sep 14.
Turgut N, Turkmen A, Gokkaya S, Altan A, Hatiboglu MA. Dexmedetomidine-based versus fentanyl-based total intravenous anesthesia for lumbar laminectomy. Minerva Anestesiol. 2008 Sep;74(9):469-74.
Other Identifiers
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16150
Identifier Type: -
Identifier Source: org_study_id
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