Oral Methadone in Cardiac Surgery

Not Applicable

Not yet recruiting

• Conditions: Pain, Postoperative; Anesthesia; Cardiac Surgery
• Interventions: Drug: Methadone, intravenously; Drug: Methadone, oral

• Registration Number: NCT07221617
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-25
• Study First Submitted QC: 2025-10-25
• Last Update Submitted: 2025-10-25
• Study First Posted: 2025-10-28
• Last Update Posted: 2025-10-28
• Study Start: 2026-01-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous methadone intraoperatively	Methadone, intravenously	Subjects in the IV methadone arm will receive methadone intravenously during cardiac surgery
Oral methadone, immediately prior to transport	Methadone, oral	Subjects in the oral methadone arm will receive methadone orally prior to cardiac surgery

Primary Outcome Measures

Name	Time	Method
Amount of opioid medication used 72 hours post-extubation	From hospital admission for surgery to 72 hours after the patient is extubated postoperatively	Opioid medication used at 72 hours post-extubation will be reported in morphine milligram equivalents

Secondary Outcome Measures

Name	Time	Method
Amount of opioid medication used 24 hours post-extubation	From hospital admission for surgery to 24 hours after the patient is extubated postoperatively	Opioid medication used at 24 hours post-extubation will be reported in morphine milligram equivalents
Amount of opioid medication used 48 hours post-extubation	From hospital admission for surgery to 48 hours after the patient is extubated postoperatively	Opioid medication used at 48 hours post-extubation will be reported in morphine milligram equivalents
Amount of opioid medication required prior to extubation	From arrival in the ICU until extubation.	Opioid medication required between the end of surgery and extubation will be documented in morphine milligram equivalents.
Pain scores after extubation	6 hours, 12 hours, 24 hours, 48 hours, and 72 hours 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.
Time to extubation	From the time the patient arrives in the ICU intubated until the time the patient is successfully extubated. If the patient is extubated in the operating room, this time will be 0.	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).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States