Status:
COMPLETED
Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
Lead Sponsor:
NYU Langone Health
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2022
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT03325972
Start Date
September 14 2016
End Date
February 22 2022
Last Update
June 5 2023
Active Locations (1)
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1
New York University School of Medicine
New York, New York, United States, 10016