Clinical trial NCT01973452: Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery
Official title: A Double-Masked Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Dexmedetomidine
Opioid
Thoracic Surgery
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 333
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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?

Primary outcomes:
measure: Total Opioid Administered
timeFrame: up to 4 hours
Secondary outcomes:
measure: Improves Analgesia
timeFrame: up to 24 hours
measure: Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center 1275 York Avenue
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alessia Pedoto, MD
role: PRINCIPAL_INVESTIGATOR
References: