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NCT Number: NCT07221617

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.

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Key information

Conditions

Pain, Postoperative Anesthesia Cardiac Surgery Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Anesthesia Clinical Research Unit

CONTACT

866-265-9263

Krishnan Ramanujan, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methadone, oral

Drug

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

Methadone, intravenously

Drug

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

Primary outcomes

  1. Amount of opioid medication used 72 hours post-extubation

    Time frame: 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 outcomes

  1. Amount of opioid medication used 24 hours post-extubation

    Time frame: 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

  2. Amount of opioid medication used 48 hours post-extubation

    Time frame: 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

  3. Amount of opioid medication required throughout hospitalization

    Time frame: 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.

    Opioid medication required from extubation until hospital discharge will be reported in morphine milligram equivalents

  4. Amount of opioid medication required prior to extubation

    Time frame: 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.

    Opioid medication required between the end of surgery and extubation will be documented in morphine milligram equivalents.

  5. Pain scores after extubation

    Time frame: 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.

  6. Time to extubation

    Time frame: 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.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Anesthesia Clinical Research Unit

CONTACT

[email protected]

866-265-9263

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Acronym: OMICS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Oct 28, 2025
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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