Overview

Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery

Status:
Active, not recruiting
Trial end date:
2021-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Treatments:
Analgesics, Opioid
Dexmedetomidine
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?