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.
The uncertainty regarding optimal methadone dosing and the necessity of post-cardiopulmonary bypass (CPB) supplementation provides a compelling rationale for this study. Specifically, it remains unknown whether a single higher initial dose of methadone can adequately maintain analgesic plasma concentrations throughout cardiac surgery and recovery, or if a split-dosing strategy administering a lower initial dose followed by an additional dose post-CPB might offer similar or improved analgesic outcomes with fewer side effects. This study will evaluate pharmacokinetics of methadone using three different dosing strategies in patients undergoing cardiac surgery with CPB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Single dose of methadone 0.3 mg/kg actual body weight (max 30 mg) administered at induction of anesthesia
Split 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 0.15 mg/kg actual body weight at induction and 0.15 mg/kg actual body weight post cardiopulmonary bypass
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
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 minutes
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 minutes
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 minutes
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 minutes
Plasma methadone concentration (ng/mL) 30 min post start of cardiopulmonary bypass
Plasma methadone concentration will be measured 30 minutes after cardiopulmonary bypass started
Time frame: 30 minutes
Plasma methadone concentration (ng/mL) 60 min post start of cardiopulmonary bypass
Plasma methadone concentration will be measured 60 minutes after cardiopulmonary bypass started
Time frame: 60 minutes
Plasma methadone concentration (ng/mL) 10 min post cardiopulmonary bypass completion
Plasma methadone concentration will be measured 10 minutes after cardiopulmonary bypass ended
Time frame: 10 minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Plasma methadone concentration (ng/mL) 120 min post start of cardiopulmonary bypass
Plasma methadone concentration will be measured 120 minutes after cardiopulmonary bypass started
Time frame: 120 minutes
Plasma methadone concentration (ng/mL) before first analgesic request
Plasma methadone concentration will be measured at the time of first analgesic request by participant
Time frame: up to 72 hours
Plasma methadone concentration (ng/mL) 3 hours post Intensive Care Unit arrival
Plasma methadone concentration will be measured 3 hours post Intensive Care Unit arrival
Time frame: 3 hours
Plasma methadone concentration (ng/mL) 12 hours post Intensive Care Unit arrival
Plasma methadone concentration will be measured 12 hours post Intensive Care Unit arrival
Time frame: 12 hours
Plasma methadone concentration (ng/mL) 24 hours post Intensive Care Unit arrival
Plasma methadone concentration will be measured 24 hours post Intensive Care Unit arrival
Time frame: 24 hours
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 3
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 tube
postoperative opioid consumption
total postoperative opioid consumption in morphine milligram equivalents
Time frame: up 72 hours postop
duration of postoperative mechanical ventilation
number of minutes with postoperative mechanical ventilation
Time frame: up to 72 hours postop
time of ambulation
number of minutes until patient first ambulates after surgery
Time frame: up to 48 hours postop
length of Intensive Care Unit stay
number of hours spent in Intensive Care Unit
Time frame: up to 3 days postop
length of hospital length stay
number of days spent in hospital
Time frame: up to 7 days postop