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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01973452

Run by

Memorial Sloan Kettering Cancer Center

People needed

333

Starts

2013-10-01

Expected to finish

2022-12-22

Last updated by the study team

2024-02-20

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery

You may not qualify if…

• 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?

Where it is running

• Memorial Sloan Kettering Cancer Center at Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Cancer Center @ Suffolk — Commack, New York, United States
• Memorial Sloan Kettering Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center 1275 York Avenue — New York, New York, United States

Full record on ClinicalTrials.gov

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