Methadone Pharmacokinetics in Cardiac Surgery
ConditionPostoperative Pain Management
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWake Forest University Health Sciences
About this trial
Cardiac surgery frequently leads to significant postoperative pain, with multiple different drug regimens being utilized (both opioid and non-opioid) in an attempt to alleviate this surgical pain. Methadone is currently one of the drugs that is being utilized to help control the pain. It can be given during and/or after surgery. This study hopes to identify the optimal dose of methadone to use to treat this surgical pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Elective cardiac surgery requiring median sternotomy and cardiopulmonary bypass (CABG, valve, combined CABG/valve surgeries)
Anticipated extubation within 12 hours postoperatively
No prior opioid use within 30 days of surgery
Ability to provide informed consent
Disqualifiers
Severe liver or kidney dysfunction (Child-Pugh class B/C, eGFR <30 mL/min/1.73m², creatinine >2 mg/dL, dialysis)
Allergy to methadone or fentanyl
Use of CYP3A4 inducers (rifampin, phenytoin, carbamazepine), CYP3A4 inhibitors (ketoconazole, erythromycin, clarithromycin, itraconazole), SSRIs (fluoxetine, sertraline, paroxetine, citalopram, escitalopram, fluvoxamine)
Body mass index >40 kg/m²
Trial design
Design model
Parallel
Treatments tested in this trial
Single dose of methadone
DrugSingle dose of methadone 0.3 mg/kg actual body weight (max 30 mg) administered at induction of anesthesia
Split dose of methadone
DrugSplit dose of methadone 0.2 mg/kg actual body weight at induction and 0.1 mg/kg actual body weight post cardiopulmonary bypass
Balanced split dose of methadone
DrugBalanced split dose of methadone 0.15 mg/kg actual body weight at induction and 0.15 mg/kg actual body weight post cardiopulmonary bypass
Treatment groups
69 Participants
are divided into 3 treatment groupsGroup A: Single dose of methadoneActive comparator 1 intervention
Group B: Split dose of methadoneExperimental treatment 1 intervention
Group C: Balanced split dose of methadoneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Plasma methadone concentration (ng/mL) 10 min post initial dose
Plasma methadone concentration will be measured 10 minutes post initial methadone dose
Time frame
10 minutes2
Plasma methadone concentration (ng/mL) 30 min post initial dose
Plasma methadone concentration will be measured 30 minutes post initial methadone dose pre cardiopulmonary bypass
Time frame
30 minutes3
Plasma methadone concentration (ng/mL) 60 min post initial dose
Plasma methadone concentration will be measured 60 minutes post initial methadone dose pre cardiopulmonary bypass
Time frame
60 minutes4
Plasma methadone concentration (ng/mL) 10 min post start of cardiopulmonary bypass
Plasma methadone concentration will be measured 10 minutes after cardiopulmonary bypass started
Time frame
10 minutesSecondary outcomes
1
pain intensity score
Pain intensity score will be measured using the visual analog scale. Scores will be measured on a scale of 0-10, with 0=no pain and 10=most severe pain
Time frame
2, 4, 8, 12, 24, 48, and 72 hours postoperatively and month 32
patient global impression of change
Patient Global Impression of Change will be used to assess patient-perceived analgesic effectiveness and overall postoperative recovery. Total score range is 1-7 with a higher score indicating considerable improvement with treatment.
Time frame
24, 48, and 72 hours after removal of the breathing tube3
postoperative opioid consumption
total postoperative opioid consumption in morphine milligram equivalents
Time frame
up 72 hours postop4
duration of postoperative mechanical ventilation
number of minutes with postoperative mechanical ventilation
Time frame
up to 72 hours postopSponsors and contacts
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Source ClinicalTrials.gov
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