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

Phase 3

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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?

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	continuous infusion of 0.4 mcg/kg/hr
Placebo	Placebo	continuous infusion of 0.4 mcg/kg/hr

Primary Outcome Measures

Name	Time	Method
Total Opioid Administered	up to 4 hours	total opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours

Secondary Outcome Measures

Name	Time	Method
Improves Analgesia	up to 24 hours	as measured by change in Pain Numerical Rating Scale (NRS) preoperatively to postoperatively at rest and with activity (such as coughing). In the Pain Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'
Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation	up to 24 hours	as measured by incidence of recorded nausea or the use of antiemetics and RASS sedation scores, respectively.

Locations (4): Memorial Sloan Kettering Westchester
🇺🇸
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center at Basking Ridge
🇺🇸
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center 1275 York Avenue
🇺🇸
New York, New York, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
🇺🇸
Commack, New York, United States