Phase 4
Completed N=64
Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
Source: ClinicalTrials.gov NCT03325972 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Morphine Equivalents Used During the First 48 Hours Post-Surgery — 180; 142.5 morphine milligram equivalent (MME)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morphine Equivalents Used During the First 48 Hours Post-Surgery |
180; 142.5 | — |
| SECONDARY Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery |
7.27; 6.53 | — |
| SECONDARY Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery |
3; 3.26 | — |
| SECONDARY Morphine Equivalents Used at 6 Weeks Post-Surgery |
0; 0 | — |
| SECONDARY Number of Participants Requiring Pressor Use During Intraoperative Period |
25; 20 | — |
| SECONDARY Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery |
7; 2 | — |
| SECONDARY Length of PACU Stay |
172; 152 | — |
| SECONDARY Length of Hospital Stay |
5.89; 5.03 | — |
| SECONDARY Mean Quality of Recovery After Anesthesia (QoR-15) Scores During the First 48 Hours Post-Surgery |
90.73; 89.3 | — |
| SECONDARY Quality of Recovery After Anesthesia (QoR-15) Score at 6 Weeks Post-Surgery |
115.5; 120.67 | — |
| SECONDARY Mean Short-Form McGill Pain Questionnaire (SF-MPQ) Scores During First 48 Hours Post-Surgery |
27.9; 25.5 | — |
| SECONDARY Short-Form McGill Pain Questionnaire (SF-MPQ) Scores at 6 Weeks Post-Surgery |
15.2; 12.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT03325972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.