Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Dexmedetomidine

Criteria

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