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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous methadone intraoperatively | Active Comparator | Subjects in the IV methadone arm will receive methadone intravenously during cardiac surgery |
|
| Oral methadone, immediately prior to transport | Experimental | Subjects in the oral methadone arm will receive methadone orally prior to cardiac surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone, oral | Drug | Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of opioid medication used 72 hours post-extubation | Opioid medication used at 72 hours post-extubation will be reported in morphine milligram equivalents | From hospital admission for surgery to 72 hours after the patient is extubated postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of opioid medication used 24 hours post-extubation | Opioid medication used at 24 hours post-extubation will be reported in morphine milligram equivalents | From hospital admission for surgery to 24 hours after the patient is extubated postoperatively |
| Amount of opioid medication used 48 hours post-extubation |
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Inclusion Criteria:
• Undergoing elective cardiac surgery
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anesthesia Clinical Research Unit | Contact | 866-265-9263 | Paul.Johar@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Krishnan Ramanujan, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Methadone, intravenously | Drug | Patients will receive 0.3mg/kg methadone intravenously after induction of general anesthesia |
|
Opioid medication used at 48 hours post-extubation will be reported in morphine milligram equivalents |
| From hospital admission for surgery to 48 hours after the patient is extubated postoperatively |
| Amount of opioid medication required throughout hospitalization | Opioid medication required from extubation until hospital discharge will be reported in morphine milligram equivalents | 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 | Opioid medication required between the end of surgery and extubation will be documented in morphine milligram equivalents. | 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 | 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. | 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after extubation |
| Time to extubation | 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). | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |