Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dexmedetomidine continuous infusion of 0.4 mcg/kg/hr |
Drug: Dexmedetomidine
|
| Placebo Comparator: Placebo continuous infusion of 0.4 mcg/kg/hr |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- total opioid administered [up to 4 hours]
total opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours
Secondary Outcome Measures
- Improves analgesia [up to 24 hours]
as measured by change in Pain Numerical Rating Scale (NRS) preoperatively to postoperatively at rest and with activity (such as coughing).
- Results in fewer cumulative episodes of nausea or antiemetic doses and/or sedation [up to 24 hours]
as measured by incidence of recorded nausea, the use of antiemetics and RASS sedation scores, respectively.
Eligibility Criteria
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
Yes or NO?; Is ALT greater than 2 x Upper Limit of Normal (> 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?
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Cancer Center at Basking Ridge | Basking Ridge | New Jersey | United States | |
| 2 | Memorial Sloan Kettering Cancer Center @ Suffolk | Commack | New York | United States | 11725 |
| 3 | Memorial Sloan Kettering Westchester | Harrison | New York | United States | 10604 |
| 4 | Memorial Sloan Kettering Cancer Center 1275 York Avenue | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Alessia Pedoto, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 13-163