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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01973452
Recruitment Status : Active, not recruiting
First Posted : October 31, 2013
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Dexmedetomidine Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Masked Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery
Actual Study Start Date : October 2013
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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).

  2. Results in fewer cumulative episodes of nausea or antiemetic doses and/or sedation [ Time Frame: up to 24 hours ]
    as measured by incidence of recorded nausea, the use of antiemetics and RASS sedation scores, respectively.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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?


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973452


Locations
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United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center 1275 York Avenue
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Alessia Pedoto, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01973452     History of Changes
Other Study ID Numbers: 13-163
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

Keywords provided by Memorial Sloan Kettering Cancer Center:
Dexmedetomidine
Opioid
Thoracic Surgery

Additional relevant MeSH terms:
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Analgesics, Opioid
Dexmedetomidine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action