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

NCT01973452 | Completed Phase 3 Results

• 1 other identifier: 13-163
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 4

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.

Conditions

Pain

Keywords

Dexmedetomidine; Opioid; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Improves Analgesia

  up to 24 hours

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

  up to 24 hours

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

continuous infusion of 0.4 mcg/kg/hr

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

continuous infusion of 0.4 mcg/kg/hr

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Dexmedetomidine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery

You may not qualify if:

• nd 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?

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (4)

Memorial Sloan Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center 1275 York Avenue

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Pain

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Alessia Pedoto, MD
• Organization: Memorial Sloan Kettering Cancer Center

pedotoa@mskcc.org

212-639-6840

Study Officials

• Alessia Pedoto, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: October 31, 2013
• Study Start: October 1, 2013
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: February 20, 2024
• Results First Posted: February 20, 2024

Record last verified: 2022-12

Locations

US (4)