Oral Methadone in Cardiac Surgery

NCT ID: NCT07221617

Last Updated: 2026-01-14

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-13

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the effects of administration of oral methadone preoperatively and intravenous methadone upon induction of general anesthesia on postoperative pain for patients undergoing elective cardiac surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative Anesthesia Cardiac Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intravenous methadone intraoperatively

Subjects in the IV methadone arm will receive methadone intravenously during cardiac surgery

Group Type ACTIVE_COMPARATOR

Methadone, intravenously

Intervention Type DRUG

Patients will receive 0.3mg/kg methadone intravenously after induction of general anesthesia

Oral methadone, immediately prior to transport

Subjects in the oral methadone arm will receive methadone orally prior to cardiac surgery

Group Type EXPERIMENTAL

Methadone, oral

Intervention Type DRUG

Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methadone, oral

Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room

Intervention Type DRUG

Methadone, intravenously

Patients will receive 0.3mg/kg methadone intravenously after induction of general anesthesia

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

• Undergoing elective cardiac surgery

Exclusion Criteria

* Chronic pain requiring opioid medications as an outpatient
* Opioid use disorder on medication assistance treatment
* Prolonged QTc \>500ms
* Chronic kidney disease with eGFR \< 30mL/min
* Documented cirrhosis
* Intolerance to methadone
* Admitted inpatient in an intensive care unit (ICU) immediately prior to surgery
* Pregnancy at the time of surgery
* Subsequent surgeries after index surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Krishnan Ramanujan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Krishnan Ramanujan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anesthesia Clinical Research Unit

Role: CONTACT

866-265-9263

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anesthesia Clinical Research Unit

Role: primary

866-265-9263

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

25-007292

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Precision Analgesia for Cardiac Surgery
NCT05612399 NOT_YET_RECRUITING
Methadone in Cystectomy Patients
NCT04475029 COMPLETED NA
Methadone and Ketamine for Spinal Surgery
NCT02827526 COMPLETED PHASE4