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Methadone Pharmacokinetics in Cardiac Surgery

NCT ID: NCT07226245

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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The uncertainty regarding optimal methadone dosing and the necessity of post-cardiopulmonary bypass (CPB) supplementation provides a compelling rationale for this study. Specifically, it remains unknown whether a single higher initial dose of methadone can adequately maintain analgesic plasma concentrations throughout cardiac surgery and recovery, or if a split-dosing strategy administering a lower initial dose followed by an additional dose post-CPB might offer similar or improved analgesic outcomes with fewer side effects. This study will evaluate pharmacokinetics of methadone using three different dosing strategies in patients undergoing cardiac surgery with CPB.

Conditions

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Postoperative Pain Management

Keywords

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methadone pharmacokinetics cardiac surgery pain management cardiac surgery recovery methadone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single dose of methadone

Single dose of methadone administered at induction of anesthesia

Group Type ACTIVE_COMPARATOR

Single dose of methadone

Intervention Type DRUG

Single dose of methadone 0.3 mg/kg actual body weight (max 30 mg) administered at induction of anesthesia

Split dose of methadone

Split dose of methadone post cardiopulmonary bypass

Group Type EXPERIMENTAL

Split dose of methadone

Intervention Type 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

Balanced split dose of methadone post cardiopulmonary bypass

Group Type EXPERIMENTAL

Balanced split dose of methadone

Intervention Type 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

Interventions

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Single dose of methadone

Single dose of methadone 0.3 mg/kg actual body weight (max 30 mg) administered at induction of anesthesia

Intervention Type DRUG

Split dose of methadone

Split dose of methadone 0.2 mg/kg actual body weight at induction and 0.1 mg/kg actual body weight post cardiopulmonary bypass

Intervention Type DRUG

Balanced split dose of methadone

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elective cardiac surgery requiring median sternotomy and cardiopulmonary bypass (CABG, valve, combined CABG/valve surgeries)
* Anticipated extubation within 12 hours postoperatively
* No prior opioid use within 30 days of surgery
* Ability to provide informed consent

Exclusion Criteria

* Severe liver or kidney dysfunction (Child-Pugh class B/C, eGFR \<30 mL/min/1.73m², creatinine \>2 mg/dL, dialysis)
* Allergy to methadone or fentanyl
* Use of CYP3A4 inducers (rifampin, phenytoin, carbamazepine), CYP3A4 inhibitors (ketoconazole, erythromycin, clarithromycin, itraconazole), SSRIs (fluoxetine, sertraline, paroxetine, citalopram, escitalopram, fluvoxamine)
* Body mass index \>40 kg/m²
* Corrected QT interval interval \>500 milliseconds
* Intubation anticipated \>12 hours
* History of illicit drug use or alcohol or opioid abuse use disorder within last 12 months
* Mechanical circulatory support, heart transplant, deep hypothermic circulatory arrest procedures
* Left Ventricular Ejection Fraction \<30%
* Pulmonary disease requiring oxygen therapy
* Preoperative inotropic support or intra-aortic balloon pump
* Emergency surgery
* Postoperative regional anesthesia
* Hemofiltration during cardiopulmonary bypass
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ettore Crimi, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Ettore Crimi, MD

Role: CONTACT

Phone: 336-716-4498

Email: [email protected]

Lynnette Harris, BSN

Role: CONTACT

Phone: 336-716-8791

Email: [email protected]

Facility Contacts

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Lynnette Harris, BSN, RN

Role: primary

Other Identifiers

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IRB00136746

Identifier Type: -

Identifier Source: org_study_id