Oral Methadone in Cardiac Surgery (OMICS)

Mayo Clinic

Status and phase: Enrolling; Phase 4

Conditions: Cardiac Surgery; Pain, Postoperative; Anesthesia

Treatments: Drug: Methadone, intravenously; Drug: Methadone, oral

Study type: Interventional

Funder types: Other

Identifiers

NCT07221617

25-007292

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Intravenous methadone intraoperatively

Active Comparator group

Description:

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

Treatment:

Drug: Methadone, intravenously

Oral methadone, immediately prior to transport

Experimental group

Description:

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

Treatment:

Drug: Methadone, oral