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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Actual): 333
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States
      • Memorial Sloan Kettering Cancer Center at Basking Ridge
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Cancer Center @ Suffolk
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center 1275 York Avenue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; continuous infusion of 0.4 mcg/kg/hr	Drug: Dexmedetomidine
Placebo Comparator: Placebo; continuous infusion of 0.4 mcg/kg/hr	Drug: Placebo

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). 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'	up to 24 hours
Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation	as measured by incidence of recorded nausea or the use of antiemetics and RASS sedation scores, respectively.	up to 24 hours

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Alessia Pedoto, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: October 30, 2013
• First Posted (Estimated): October 31, 2013

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Opioid; Dexmedetomidine; Thoracic Surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 13-163