Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
83 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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