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

Status:	Active, not recruiting
Conditions:	Chronic Pain
Therapuetic Areas:	Musculoskeletal
Healthy:	No
Age Range:	21 - Any
Updated:	2/13/2019
Start Date:	October 2013
End Date:	October 2020

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

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.

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.

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?

We found this trial at

sites

Memorial Sloan-Kettering Cancer Center - Basking Ridge

136 Mountainview Blvd
Basking Ridge, New Jersey 7920

(908) 542-3000