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OpenTrials
Completed

NCT Number: NCT01850017

Study of Dexmedetomidine in Spine Surgery

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.

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Key information

Conditions

Collapse of Thoracic Vertebra Collapse of Lumbar Vertebrae

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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 names: Precedex

Primary outcomes

  1. Opiate consumption

    Time frame: 72 hours post surgery

    We will measure total opiate consumption 72 hours post surgery

Secondary outcomes

  1. Pain Scores on the Visual Analog Scale

    Time frame: 72 hours

    We will measure pain scores on the Visual analogue scale after surgery

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Prospective Randomized Double Blind Study of Intraoperative Dexmedetomidine and Postoperative Pain Control in Patients Undergoing Multi-level Thoraco-lumbar Spine Surgery

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 9, 2013
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.