Clinical trial NCT03325972: Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
Official title: Randomized, Double-blind, Placebo-controlled Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility 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

Primary outcomes:
measure: Morphine Equivalents Used During the First 48 Hours Post-Surgery
timeFrame: Up to 48 Hours Post-Surgery (Day 2)
Secondary outcomes:
measure: Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery
timeFrame: 48 Hours Post-Surgery (Day 2)
measure: Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery
timeFrame: Week 6
measure: Morphine Equivalents Used at 6 Weeks Post-Surgery
timeFrame: Up to Week 6
measure: Number of Participants Requiring Pressor Use During Intraoperative Period
timeFrame: From beginning up to end of surgery (Day 0 - typically 1 to 3 hours)
measure: Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery
timeFrame: Up to 48 Hours Post-Surgery (Day 2)
measure: Length of PACU Stay
timeFrame: From PACU admission up to end of PACU stay (Day 0 - typically 1 to 3 hours)
measure: Length of Hospital Stay
timeFrame: From admission up to discharge (Up to 6 Weeks)
measure: Mean Quality of Recovery After Anesthesia (QoR-15) Scores During the First 48 Hours Post-Surgery
timeFrame: 48 Hours Post-Surgery (Day 2)
measure: Quality of Recovery After Anesthesia (QoR-15) Score at 6 Weeks Post-Surgery
timeFrame: Week 6
measure: Mean Short-Form McGill Pain Questionnaire (SF-MPQ) Scores During First 48 Hours Post-Surgery
timeFrame: 48 Hours Post-Surgery (Day 2)
measure: Short-Form McGill Pain Questionnaire (SF-MPQ) Scores at 6 Weeks Post-Surgery
timeFrame: Week 6
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lisa Doan, MD
role: PRINCIPAL_INVESTIGATOR
References: