Anesthesia, Cardiac Surgery
Conditions
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.
Interventions
DRUGOral methadone, immediately prior to transport
Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room
Patients will receive 0.3mg/kg IV methadone after induction of general anesthesia
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use in Morphine Milligram Equivalents 24 Hours After Extubation | From hospital admission for surgery to 24 hours after the patient is extubated postoperatively | Oral morphine milligram equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use in Morphine Milligram Equivalents 48 Hours After Extubation | From hospital admission for surgery to 48 hours after the patient is extubated postoperatively | Oral morphine milligram equivalents |
| Opioid Use in Morphine Milligram Equivalents 72 Hours After Extubation | From hospital admission for surgery to 72 hours after the patient is extubated postoperatively | Oral morphine milligram equivalents |
| Pain Score 6 Hours After Extubation | From hospital admission for surgery to 6 hours after extubation postoperatively | Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable. |
| Pain Score 12 Hours After Extubation | From hospital admission for surgery to 12 hours after extubation postoperatively | Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable. |
| Pain Score 24 Hours After Extubation | From hospital admission for surgery to 24 hours after extubation postoperatively | Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable. |
| Pain Score 48 Hours After Extubation | From hospital admission for surgery to 48 hours after extubation postoperatively | Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable. |
| Pain Score 72 Hours After Extubation | From hospital admission for surgery to 72 hours after extubation postoperatively | Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable. |
| Time to Extubation | From the time the patient arrives in the ICU intubated until the time the patient is successfully extubated. | 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). |
| Opioid Use in MMEs Prior to Extubation | From the time the patient arrives in the ICU intubated until the time the patient is successfully extubated. | This outcome will assess the need for pain medications (opioids) to make patients comfortable prior to removing the breathing tube (extubation). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKrishnan Ramanujan
Mayo Clinic
Participant flow
Recruitment details
Patients were enrolled between April and July 2025, with the first patient being accrued on April 14 and the last being accrued on July 7. Potential study subjects were approached in preoperative clinic or contacted via telephone to discuss the study including risks, benefits, and alternatives.
Pre-assignment details
There were no patients who were excluded from this study between enrollment and randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| ACE inhibitor use | 5 Participants |
| Age, Continuous | 61.8 Years STANDARD_DEVIATION 16 |
| American Society of Anesthesiologists Physical Status Classification | 4 Scores on a scale |
| ARB use | 8 Participants |
| Asthma | 5 Participants |
| Beta blocker use | 8 Participants |
| BMI | 27.8 kg/m^2 |
| Calcium channel blocker use | 5 Participants |
| Chronic kidney disease | 9 Participants |
| COPD | 1 Participants |
| Diuretic use | 11 Participants |
| Height (cm) | 173.9 cm STANDARD_DEVIATION 11.2 |
| Nitrate use | 9 Participants |
| Obstructive sleep apnea | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 15 Participants |
| Weight (kg) | 89.9 kg STANDARD_DEVIATION 21.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 20 | 1 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
None listed