Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2026-01-13
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intravenous methadone intraoperatively
Subjects in the IV methadone arm will receive methadone intravenously during cardiac surgery
Methadone, intravenously
Patients will receive 0.3mg/kg methadone intravenously after induction of general anesthesia
Oral methadone, immediately prior to transport
Subjects in the oral methadone arm will receive methadone orally prior to cardiac surgery
Methadone, oral
Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Krishnan Ramanujan
Principal Investigator
Principal Investigators
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Krishnan Ramanujan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Anesthesia Clinical Research Unit
Role: primary
Other Identifiers
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25-007292
Identifier Type: -
Identifier Source: org_study_id
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