CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 142 enrolled
Drug / intervention
Dexmedetomidinedrug
Likely dose
Dexmedetomidine 1 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01850017
NCT01850017Phase 4Completed
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Prospective Randomized Double Blind Study of Intraoperative Dexmedetomidine and Postoperative Pain Control in Patients Undergoing Multi-level Thoraco-lumbar Spine Surgery

University of Virginia·interventional·Posted May 9, 2013·Updated May 5, 2017

In Brief

A Phase 4 clinical trial evaluating Dexmedetomidine for Collapse of Thoracic Vertebra and Collapse of Lumbar Vertebrae. Completed, enrolled 142 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCollapse of Thoracic Vertebra, Collapse of Lumbar Vertebrae
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 9, 2013
Enrollment StartAug 1, 2012
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.1 years ago

Interventions

Dexmedetomidinedrug

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.