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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of methadone | Active Comparator | Single dose of methadone administered at induction of anesthesia |
|
| Split dose of methadone | Experimental | Split dose of methadone post cardiopulmonary bypass |
|
| Balanced split dose of methadone | Experimental | Balanced split dose of methadone post cardiopulmonary bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose of methadone | Drug | Single dose of methadone 0.3 mg/kg actual body weight (max 30 mg) administered at induction of anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma methadone concentration (ng/mL) 10 min post initial dose | Plasma methadone concentration will be measured 10 minutes post initial methadone dose | 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 | 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 | 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 | 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 | 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 | 60 minutes |
| Plasma methadone concentration (ng/mL) 10 min post cardiopulmonary bypass completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2, 4, 8, 12, 24, 48, and 72 hours postoperatively and month 3 |
| patient global impression of change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ettore Crimi, MD | Contact | 336-716-4498 | ettore.crimi@advocatehealth.org | |
| Lynnette Harris, BSN | Contact | 336-716-8791 | lynnette.harris@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Ettore Crimi, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
study results will be shared instead of individual patient data
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Split dose of methadone | Drug | 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 | Drug | 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 |
|
Plasma methadone concentration will be measured 10 minutes after cardiopulmonary bypass ended
| 10 minutes |
| Plasma methadone concentration (ng/mL) 120 min post start of cardiopulmonary bypass | Plasma methadone concentration will be measured 120 minutes after cardiopulmonary bypass started | 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 | 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 | 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 | 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 | 24 hours |
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. |
| 24, 48, and 72 hours after removal of the breathing tube |
| postoperative opioid consumption | total postoperative opioid consumption in morphine milligram equivalents | up 72 hours postop |
| duration of postoperative mechanical ventilation | number of minutes with postoperative mechanical ventilation | up to 72 hours postop |
| time of ambulation | number of minutes until patient first ambulates after surgery | up to 48 hours postop |
| length of Intensive Care Unit stay | number of hours spent in Intensive Care Unit | up to 3 days postop |
| length of hospital length stay | number of days spent in hospital | up to 7 days postop |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |