Oral and Intravenous Methadone for Analgesia in Cardiac Surgery

NCT ID: NCT06720415

Last Updated: 2026-01-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-14

Study Completion Date

2025-07-14

Brief Summary

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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

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Conditions

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Anesthesia Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral methadone, immediately prior to transport

Group Type EXPERIMENTAL

Oral methadone, immediately prior to transport

Intervention Type DRUG

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

Intravenous methadone

Group Type ACTIVE_COMPARATOR

Intravenous methadone

Intervention Type DRUG

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

Interventions

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Oral methadone, immediately prior to transport

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

Intervention Type DRUG

Intravenous methadone

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Undergoing elective cardiac surgery as the first case of the day in an operating room

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
* Subsequent surgeries after index surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Krishnan Ramanujan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Krishnan Ramanujan

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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24-006579

Identifier Type: -

Identifier Source: org_study_id

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