Study of Dexmedetomidine in Spine Surgery

Phase 4

Completed

• Conditions: Collapse of Thoracic Vertebra; Collapse of Lumbar Vertebrae
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT01850017
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-04-30
• Study First Submitted QC: 2013-05-06
• Study First Posted: 2013-05-09
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methadone and dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Opiate consumption	72 hours post surgery	We will measure total opiate consumption 72 hours post surgery

Secondary Outcome Measures

Name	Time	Method
Pain Scores on the Visual Analog Scale	72 hours	We will measure pain scores on the Visual analogue scale after surgery

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States