Phase 3
N=331
Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01973452 ↗Enrolled (actual)
331
Serious AEs
4.3%
Results posted
Feb 2024
Primary outcome: Primary: Total Opioid Administered — 4.0; 6.0 Morphine Milligram Equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexmedetomidine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Administered |
4.0; 6.0 | — |
| SECONDARY Improves Analgesia |
4.0; 4.0 | — |
| SECONDARY Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation |
113; 110; 35; 42 | — |
Summary
The purpose of this study is to see if the drug, Dexmedetomidine (also known as Precedex), can reduce pain for patients having Thoracic Surgery and therefore reduce the amount of opioid drug needed after surgery. It is a drug that is already approved by the FDA (Food & Drug Administration) for use as a sedative in hospitals and is currently used in the investigators Intensive Care Unit for this purpose. The investigators want to investigate if it also has pain relieving properties.
Eligibility Criteria
Inclusion Criteria
- Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery
Exclusion Criteria
- 2nd or 3rd degree heart block as assessed by preoperative EKG
- Use of dexmedetomidine within 28 days prior to day of surgery
- Use of long acting opioids pre-operatively 28 days prior to day of surgery
- Current or past diagnosis of a Major Psychiatric disorder precluding adequate outcome responses such as Schizophrenia, dementia, delirium etc. as recorded in the Pre-Operative Record.
- Documentation of congestive heart failure and Ejection fraction 75 U/L)?
- Abnormal renal function tests as related to contraindications to use of IV Ketorolac
Yes or No?; Is Serum Creatinine < 1.5 mg/dl?
Data sourced from ClinicalTrials.gov (NCT01973452). 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.