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

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NYU Langone Health

Status and phase

Completed
Phase 4

Conditions

Chronic Pain

Treatments

Other: Placebo Saline
Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT03325972
14-00915

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

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy 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

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

83 participants in 2 patient groups, including a placebo group

IV dexmedetomidine
Experimental group
Description:
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Treatment:
Drug: Dexmedetomidine
Placebo
Placebo Comparator group
Description:
saline placebo
Treatment:
Other: Placebo Saline

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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