Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/7/2018 |
| Start Date: | September 14, 2016 |
| End Date: | February 2019 |
| Contact: | Lola Franco |
| Email: | lola.franco@nyumc.org |
| Phone: | 212 263 0531 |
Randomized, Double-blind, Placebo-controlled Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
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.
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.
Inclusion Criteria:
- Adults who will undergo lumbar spinal fusion, including surgeries extending into
thoracic and sacral segments
- Subject is non-lactating and is either:
- Not of childbearing potential
- Of childbearing potential but is not pregnant at time of surgery as determined by
pre-surgical pregnancy testing
- Subject is ASA physical status 1, 2, or 3.
Exclusion Criteria:
- Subject is pregnant or breastfeeding
- Any subject whom the investigators deem unable to complete any/all research related
tasks
- Subjects who are cognitively impaired (by history)
- Subject requires antipsychotic medications
- Subject has received treatment with alpha-2 agonists or antagonists within 2 weeks
prior to surgery
- Subject has known allergy to dexmedetomidine
- Subjects with impaired renal or hepatic function
- Subjects with advanced heart block
- Subjects with severe ventricular dysfunction
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Lisa Doan, MD
Phone: 212-263-0531
New York University School of Medicine NYU School of Medicine has a proud history that...
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