Methadone Pharmacokinetics in Cardiac Surgery

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07226245
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Postoperative Pain Management

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Single dose of methadone — DRUG
    Single dose of methadone 0.3 mg/kg actual body weight (max 30 mg) administered at induction of anesthesia
  • Split dose of methadone — DRUG
    Split dose of methadone 0.2 mg/kg actual body weight at induction and 0.1 mg/kg actual body weight post cardiopulmonary bypass
  • Balanced split dose of methadone — DRUG
    Balanced split dose of methadone 0.15 mg/kg actual body weight at induction and 0.15 mg/kg actual body weight post cardiopulmonary bypass

Study Details

Cardiac surgery frequently leads to significant postoperative pain, with multiple different drug regimens being utilized (both opioid and non-opioid) in an attempt to alleviate this surgical pain. Methadone is currently one of the drugs that is being utilized to help control the pain. It can be given during and/or after surgery. This study hopes to identify the optimal dose of methadone to use to treat this surgical pain.

Key Dates

Start date
Sep 30, 2026
Status verified
Sep 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
69 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Single dose of methadone
    Single dose of methadone administered at induction of anesthesia
  • Experimental: Split dose of methadone
    Split dose of methadone post cardiopulmonary bypass
  • Experimental: Balanced split dose of methadone
    Balanced split dose of methadone post cardiopulmonary bypass

Primary Outcome Measure

Plasma methadone concentration (ng/mL) 10 min post initial dose [ Time Frame: 10 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Lynnette Harris, BSN, RN
[email protected]
336-306-0778
Ettore Crimi, MD (PRINCIPAL_INVESTIGATOR)

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Wake Forest University Health Sciences· Winston-Salem, NC

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