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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Dexmedetomidine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01973452

13-163

Details and patient eligibility

About

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.

Full 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.

Enrollment: 333 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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?

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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333 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Experimental group

Description:

continuous infusion of 0.4 mcg/kg/hr

Treatment:

Drug: Dexmedetomidine

Placebo

Placebo Comparator group

Description:

continuous infusion of 0.4 mcg/kg/hr

Treatment:

Drug: Placebo