Oral Methadone in Cardiac Surgery

NCT07221617 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 25-007292
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Pain, Postoperative; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Amount of opioid medication used 72 hours post-extubation

  Opioid medication used at 72 hours post-extubation will be reported in morphine milligram equivalents

  From hospital admission for surgery to 72 hours after the patient is extubated postoperatively

Secondary Outcomes (6)

• Amount of opioid medication used 24 hours post-extubation

  From hospital admission for surgery to 24 hours after the patient is extubated postoperatively

• Amount of opioid medication used 48 hours post-extubation

  From hospital admission for surgery to 48 hours after the patient is extubated postoperatively

• Amount of opioid medication required throughout hospitalization

  From the time the patient is extubated until the time the patient leaves the hospital, approximately 10 days. Safety to leave the hospital is determined by the cardiac surgery team and can be several days after surgery or longer.

• Amount of opioid medication required prior to extubation

  From arrival in the ICU until extubation, approximately 6 hours. Safety of extubation is determined by the intensive care unit team and usually occurs within several hours of ICU arrival, although this can be variable.

• Pain scores after extubation

  6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after extubation

Study Arms (2)

Intravenous methadone intraoperatively

ACTIVE COMPARATOR

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

Drug: Methadone, intravenously

Oral methadone, immediately prior to transport

EXPERIMENTAL

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

Drug: Methadone, oral

Interventions

Methadone, oral DRUG

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

Oral methadone, immediately prior to transport

Methadone, intravenously DRUG

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

Intravenous methadone intraoperatively

Eligibility Criteria

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

You may qualify if:

• Undergoing elective cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Krishnan Ramanujan, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anesthesia Clinical Research Unit

CONTACT

866-265-9263; Paul.Johar@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2025
• First Posted: October 28, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)