A Double-Masked Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery
Overview
- Phase
- Phase 3
- Intervention
- Dexmedetomidine
- Conditions
- Pain
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 333
- Locations
- 4
- Primary Endpoint
- Total Opioid Administered
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
The study involves the use of dexmedetomidine infusion intraoperatively during thoracic surgical procedures (not using an epidural) with discontinuation in the immediate postoperative period. A key feature in this study is to employ the drug infusion intraoperatively only.
Investigators
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 \< 30% if recorded in the Pre-Operative Record.
- •Planned use of an epidural for surgery or post-operative pain relief
- •Contraindication to use of NSAID, Acetaminophen or IV opioids.
- •Any known hypersensitivity to dexmedetomidine
- •Pregnant or breastfeeding
- •Abnormal liver function tests as related to the MSK guidelines for use of IV Acetaminophen
Arms & Interventions
Dexmedetomidine
continuous infusion of 0.4 mcg/kg/hr
Intervention: Dexmedetomidine
Placebo
continuous infusion of 0.4 mcg/kg/hr
Intervention: Placebo
Outcomes
Primary Outcomes
Total Opioid Administered
Time Frame: up to 4 hours
total opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours
Secondary Outcomes
- Improves Analgesia(up to 24 hours)
- Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation(up to 24 hours)