Oral Methadone in Cardiac Surgery

Purpose

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.

Conditions

  • Pain, Postoperative
  • Anesthesia
  • Cardiac Surgery

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Anesthesia Clinical Research Unit
866-265-9263

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Anesthesia Clinical Research Unit
866-265-9263
Paul.Johar@mayo.edu