Recruiting NCT07221617
Oral Methadone in Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methadone, oral, Methadone, intravenously.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative, Anesthesia, Cardiac Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Oral Methadone In Cardiac Surgery
Overview
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
- Drug Methadone, oral
Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room - Drug Methadone, intravenously
Patients will receive 0.3mg/kg methadone intravenously after induction of general anesthesia
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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]
- 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]
- 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.]
- 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.]
- Pain scores after extubation [Time frame: 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after extubation]
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07221617 · 25-007292