Skip to main content
OpenTrials
Completed

NCT Number: NCT01973452

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge, New Jersey, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

Dexmedetomidine

Drug

Placebo

Drug

Primary outcomes

  1. Total Opioid Administered

    Time frame: up to 4 hours

    total opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours

Secondary outcomes

  1. Improves Analgesia

    Time frame: 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'

  2. Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation

    Time frame: up to 24 hours

    as measured by incidence of recorded nausea or the use of antiemetics and RASS sedation scores, respectively.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2013
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.