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

Study Overview
=================
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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Placebo


Participation Criteria
=================
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?

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>continuous infusion of 0.4 mcg/kg/hr | Drug: Dexmedetomidine<br> <br> |
| Placebo Comparator: Placebo<br>continuous infusion of 0.4 mcg/kg/hr | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total opioid administered | total opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours | up to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improves analgesia | as measured by change in Pain Numerical Rating Scale (NRS) preoperatively to postoperatively at rest and with activity (such as coughing). | up to 24 hours | 
| Results in fewer cumulative episodes of nausea or antiemetic doses and/or sedation | as measured by incidence of recorded nausea, the use of antiemetics and RASS sedation scores, respectively. | up to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexmedetomidine, Opioid, Thoracic Surgery