search
Back to results

Study of Dexmedetomidine in Spine Surgery

Primary Purpose

Collapse of Thoracic Vertebra, Collapse of Lumbar Vertebrae

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Collapse of Thoracic Vertebra focused on measuring Opiate consumption, Visual Analogue Scale

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-80 years of age
  • Elective multi-level thoracic and/or lumbar spine surgery requiring SSEP, EMG or MEP monitoring

Exclusion Criteria:

  • Emergency spine surgery
  • 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

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Methadone and dexmedetomidine

Methadone and placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Opiate consumption
We will measure total opiate consumption 72 hours post surgery

Secondary Outcome Measures

Pain Scores on the Visual Analog Scale
We will measure pain scores on the Visual analogue scale after surgery

Full Information

First Posted
April 30, 2013
Last Updated
May 4, 2017
Sponsor
University of Virginia
search

1. Study Identification

Unique Protocol Identification Number
NCT01850017
Brief Title
Study of Dexmedetomidine in Spine Surgery
Official Title
Prospective Randomized Double Blind Study of Intraoperative Dexmedetomidine and Postoperative Pain Control in Patients Undergoing Multi-level Thoraco-lumbar Spine Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will conduct a prospective randomized double blind study comparing methadone plus methadone and intraoperative dexmedetomidine in multi-level spine surgery in two randomized groups. The investigators plan to document the intraoperative opioid requirements, time to first dose of opioids postoperatively and total opioid consumption in the first 24, 48 and 72 hours. The incidence of intra and postoperative complications will be assessed.
Detailed Description
Patients presenting for thoracic and/or lumbar spine surgery with neuromonitoring (MEP/SSEP/EMG)will be recruited. Standard anesthesia monitoring will be performed. Randomized to a placebo or dexmedetomidine arm. Both groups will receive methadone 0.2 mg/kg ideal weight after induction of anesthesia. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Collapse of Thoracic Vertebra, Collapse of Lumbar Vertebrae
Keywords
Opiate consumption, Visual Analogue Scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methadone and dexmedetomidine
Arm Type
Experimental
Arm Description
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.
Arm Title
Methadone and placebo
Arm Type
No Intervention
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opiate consumption
Description
We will measure total opiate consumption 72 hours post surgery
Time Frame
72 hours post surgery
Secondary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Description
We will measure pain scores on the Visual analogue scale after surgery
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-80 years of age Elective multi-level thoracic and/or lumbar spine surgery requiring SSEP, EMG or MEP monitoring Exclusion Criteria: Emergency spine surgery 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhiken Naik, MBBCh
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20418538
Citation
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.
Results Reference
background
PubMed Identifier
20173643
Citation
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.
Results Reference
background
PubMed Identifier
21288211
Citation
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.
Results Reference
background
PubMed Identifier
20693876
Citation
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.
Results Reference
background
PubMed Identifier
21897496
Citation
Grewal A. Dexmedetomidine: New avenues. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):297-302. doi: 10.4103/0970-9185.83670. No abstract available.
Results Reference
background
PubMed Identifier
20707597
Citation
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.
Results Reference
background
PubMed Identifier
21916531
Citation
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.
Results Reference
background
PubMed Identifier
18762754
Citation
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.
Results Reference
background

Learn more about this trial

Study of Dexmedetomidine in Spine Surgery

We'll reach out to this number within 24 hrs