심장 수술에서 경구 메타돈 (OMICS)
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.
연구 개요
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic in Rochester
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Intravenous methadone intraoperatively
Subjects in the IV methadone arm will receive methadone intravenously during cardiac surgery |
Patients will receive 0.3mg/kg methadone intravenously after induction of general anesthesia |
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실험적: Oral methadone, immediately prior to transport
Subjects in the oral methadone arm will receive methadone orally prior to cardiac surgery |
Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Amount of opioid medication used 72 hours post-extubation
기간: From hospital admission for surgery to 72 hours after the patient is extubated postoperatively
|
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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Amount of opioid medication used 24 hours post-extubation
기간: From hospital admission for surgery to 24 hours after the patient is extubated postoperatively
|
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
|
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Amount of opioid medication used 48 hours post-extubation
기간: From hospital admission for surgery to 48 hours after the patient is extubated postoperatively
|
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
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Amount of opioid medication required throughout hospitalization
기간: 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.
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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.
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Amount of opioid medication required prior to extubation
기간: 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.
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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.
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Pain scores after extubation
기간: 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after extubation
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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
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Time to extubation
기간: 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.
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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.
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Krishnan Ramanujan, M.D., Mayo Clinic
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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