Clinical trial NCT06720415: Oral and Intravenous Methadone for Analgesia in Cardiac Surgery
Official title: Comparison of Oral and Intravenous Methadone for Analgesia in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anesthesia
Cardiac Surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Opioid Use in Morphine Milligram Equivalents 24 hours after extubation
timeFrame: From hospital admission for surgery to 24 hours after the patient is extubated postoperatively
Secondary outcomes:
measure: Opioid Use in Morphine Milligram Equivalents 48 hours after extubation
timeFrame: From hospital admission for surgery to 48 hours after the patient is extubated postoperatively
measure: Opioid Use in Morphine Milligram Equivalents 72 hours after extubation
timeFrame: From hospital admission for surgery to 72 hours after the patient is extubated postoperatively
measure: Pain score 6 hours after extubation
timeFrame: From hospital admission for surgery to 6 hours after extubation postoperatively
measure: Pain score 12 hours after extubation
timeFrame: From hospital admission for surgery to 12 hours after extubation postoperatively
measure: Pain score 24 hours after extubation
timeFrame: From hospital admission for surgery to 24 hours after extubation postoperatively
measure: Pain score 48 hours after extubation
timeFrame: From hospital admission for surgery to 48 hours after extubation postoperatively
measure: Pain score 72 hours after extubation
timeFrame: From hospital admission for surgery to 72 hours after extubation postoperatively
measure: Time to extubation
timeFrame: 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.
measure: Opioid Use in MMEs Prior to Extubation
timeFrame: 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.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Krishnan Ramanujan
role: PRINCIPAL_INVESTIGATOR
References: