At a glance
ClinicalIndex Comparison Record- ✓Undergoing lumbar spinal fusion, including surgeries extending into thoracic and sacral segments
- ✓ASA physical status 1, 2, or 3
- ✓Non-pregnant, non-lactating (or not of childbearing potential)
- ✕Pregnant or breastfeeding
- ✕Cognitive impairment by history
- ✕Requires antipsychotic medications
- ✕Alpha-2 agonist or antagonist use within 2 weeks prior to surgery
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Placebo-controlled Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
In Brief
A Phase 4 clinical trial evaluating Dexmedetomidine and Placebo Saline for Chronic Pain. Completed, enrolled 83 participants across 1 site.
Detailed Summary
This is a randomized, prospective, double-blind , placebo-controlled trial examining the effects of intraoperative dexmedetomidine infusion on pain in patients undergoing lumbar spinal fusion surgery. One hundred ten subjects (55 in each arm) will be enrolled. Subjects, over the age of 18, undergoing lumbar spinal fusion will be considered eligible for enrollment. Subjects will receive either intraoperative dexmedetomidine or placebo of normal saline infusion. They will be followed for approximately six weeks postoperatively.
Study Details
Timeline
Interventions
The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.