Oral Methadone in Cardiac Surgery (OMICS)

Oral Methadone In Cardiac Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Cardiac Surgery; Anesthesia
• Intervention / Treatment: Drug: Methadone, intravenously; Drug: Methadone, oral

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anesthesia Clinical Research Unit; Phone Number: 866-265-9263; Email: Paul.Johar@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Anesthesia Clinical Research Unit; Phone Number: 866-265-9263
      • Principal Investigator: Krishnan Ramanujan, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous methadone intraoperatively; Subjects in the IV methadone arm will receive methadone intravenously during cardiac surgery	Drug: Methadone, intravenously; Patients will receive 0.3mg/kg methadone intravenously after induction of general anesthesia
Experimental: Oral methadone, immediately prior to transport; Subjects in the oral methadone arm will receive methadone orally prior to cardiac surgery	Drug: Methadone, oral; Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of opioid medication used 24 hours post-extubation	Opioid medication used at 24 hours post-extubation will be reported in morphine milligram equivalents	From hospital admission for surgery to 24 hours after the patient is extubated postoperatively
Amount of opioid medication used 48 hours post-extubation	Opioid medication used at 48 hours post-extubation will be reported in morphine milligram equivalents	From hospital admission for surgery to 48 hours after the patient is extubated postoperatively
Pain scores after extubation	Pain will be assessed by nursing staff using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.	6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after extubation
Amount of opioid medication required throughout hospitalization	Opioid medication required from extubation until hospital discharge will be reported in morphine milligram equivalents	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	Opioid medication required between the end of surgery and extubation will be documented in morphine milligram equivalents.	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.
Time to extubation	This outcome will monitor the time in minutes from when a patient arrives in the ICU to the time the breathing tube is removed (extubation).	From the time the patient arrives in the ICU intubated until the time they are successfully extubated, approximately 12 hours. Safety of extubation is determined by the ICU team and usually occurs within several hours, although this can be variable.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Krishnan Ramanujan, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: October 25, 2025
• First Submitted That Met QC Criteria: October 25, 2025
• First Posted (Estimated): October 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Ketones; Methadone
• Other Study ID Numbers: 25-007292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No