Anesthesia, Cardiac Surgery, Pain, Postoperative
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
DRUGMethadone, oral
Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room
DRUGMethadone, intravenously
Patients will receive 0.3mg/kg methadone intravenously after induction of general anesthesia
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of opioid medication used 72 hours post-extubation | 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
| Measure | Time frame | Description |
|---|---|---|
| Amount of opioid medication used 24 hours post-extubation | 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 |
| Amount of opioid medication used 48 hours post-extubation | 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 |
| Amount of opioid medication required throughout hospitalization | 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 |
| Amount of opioid medication required prior to extubation | 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. |
| Pain scores after extubation | 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. |
| Time to extubation | 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). |
Countries
United States
Contacts
CONTACTAnesthesia Clinical Research Unit
PRINCIPAL_INVESTIGATORKrishnan Ramanujan, M.D.
Mayo Clinic
Outcome results
None listed