Recruiting

Methadone vs. Methadone

Sponsor:

Mayo Clinic

Code:

NCT07221617

Conditions

Pain, Postoperative

Anesthesia

Cardiac Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Methadone, oral

Methadone, intravenously

Study Details

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

Pain, Postoperative

Anesthesia

Cardiac Surgery

Study ID

NCT07221617

Start date

Jan 13, 2026

Status verified date

Aug, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intravenous methadone intraoperatively

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

experimental: Oral methadone, immediately prior to transport

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

Interventions

Methadone, oral

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

Methadone, intravenously

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

Primary outcome measure

  • Amount of opioid medication used 72 hours post-extubation [ Time Frame: From hospital admission for surgery to 72 hours after the patient is extubated postoperatively ]

Central Contacts and Locations

Central contacts

Anesthesia Clinical Research Unit

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Anesthesia Clinical Research Unit

866-265-9263

Principal Investigator:

Krishnan Ramanujan, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-21.