- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02452320
Prospective, Double Blind, Placebo Control, Bariatric IV Ace (Bariatricace)
Prospective, Double Blind, Placebo Control, Study of Acetaminophen iv on Hospital Length of Stay in Morbidly Obese Individuals Undergoing Elective Laparoscopic Sleeve Gastrectomy
연구 개요
상세 설명
Morbid obesity is defined as a body mass index (BMI: weight [kg] / height [m]2) ≥ 40 or ≥ 35 if associated with comorbidities, and it is widely prevalent, nationally and globally. Overweight or obese individuals have increased morbidity and mortality. Among the many available treatment options, surgical management of obesity has been shown to be the most reliably effective in achieving sustained weight loss and improvements in glycemic, lipidemic, and blood pressure control, and improves five and ten year survival in contrast to matched controls who did not have surgery. Various surgical approaches have been used to provide long-term control of morbid obesity and its associated comorbidities, including laparoscopic sleeve gastrectomy.
During a sleeve gastrectomy the greater curvature of the stomach is separated from the lesser curvature and antrum, thereby eliminating ~85% of the total stomach, including the grehlin-producing portion of the stomach. A common complication of the procedure is postoperative nausea and vomiting (PONV), occurring in nearly 80% of patients undergoing the procedure. Risk factors for PONV include: female sex, history of PONV or motion sickness, nonsmoking, younger age, general vs. regional anesthesia, use of volatile anesthetics and nitrous oxide, administration of postoperative opioids, duration of anesthesia, and type of surgery (including cholecystectomy, laparoscopic, and gynecological). At the individual level, PONV adversely impacts both patient satisfaction and quality of life scores. At the systems level, PONV is associated with increased length of stay (LOS) in the post-anesthesia care unit and hospital, and can result in increased costs.
Both pharmacological and surgical approaches have been studied in an effort to reduce the incidence of PONV in sleeve gastrectomy patients. Omentopexy was unsuccessful, and pharmacologic prophylaxis with two [dexamethasone + odansetron; dexamethasone + granisetron; aprepitant + odansetron; or three (dexamethasone + odansetron + haloperidol; antiemetic agents was more effective than a single agent (odansetron or granisetron) alone in decreasing both nausea and vomiting. Even with triple therapy, just over 50% of patients were nauseous and 20% vomited within the first 36 hours following surgery, and hospital LOS was unaffected. Thus, there is a pressing need for improved control of PONV in sleeve gastrectomy patients.
Acetaminophen (N-(4-hydroxyphenyl)acetamide; paracetamol) is a mild analgesic whose main, but not sole, mechanism of action is thought to arise from inhibition of the cyclooxygenase pathway; the intravenous (iv) formulation (acetaminophen iv; ACP-iv) received US Food and Drug Administration (FDA) approval in November 2010 but has been available in Europe since 2002. It is approved by the FDA for the management of mild to moderate pain as a single agent and the management of moderate to severe pain with adjunctive opioid analgesics. Recently, two meta-analyses have evaluated the use of ACP-iv in the postoperative period for its efficacy in preventing postoperative pain [45] or reducing PONV [46]. In the study by De Oliveria et al., ACP-iv administration was found to significantly reduce postoperative pain, opioid consumption, and PONV. Similarly, the study by Apfel and colleagues indicated that iv-ACP, when administered prophylactically, reduced PONV as a consequence of improved pain control. With direct relevance to sleeve gastrectomy patients, a retrospective analysis of patients undergoing bariatric surgery (sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass) found that ACP-iv administration reduced opiate consumption and hospital LOS.
The investigators hypothesize that administration of ACP-iv in the perioperative period will reduce hospital LOS in sleeve gastrectomy subjects and will be associated with a reduction in hospital costs. The secondary hypothesis is that administration of ACP-iv will reduce PONV and improve subject satisfaction scores in the same subject population.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10065
- Weill Cornell Medical College
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- At least 18 years old
- BMI > 30
- Undergoing Elective Sleeve Gastrectomy
- Able to consent
Exclusion Criteria:
- Allergy/ Hypersensitive to acetaminophen or formulation incipients
- Allergy/Hypersensitive to aprepitant, ondasteron (serotonin type 3 receptor antagonists), dexamethasone
- Allergy to Propofol or formulation incipients (egg albumin, soy lecithin)
- Diagnosis or positive family history of malignant hyperthermia
- Abnormal LFTs (AST and ALT) >2x local upper limits of normal
- Renal impairment (creatinine clearance (CrCl) ≤ 30mL/min adjusted for obesity))
- Pregnancy
- Alcohol consumption > 3 drinks/day
- Requires awake intubation
- Unable to provide consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Control
Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm.
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Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
다른 이름들:
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활성 비교기: Randomized
Subjects randomized into the active treatment group will receive intravenous acetaminophen
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administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Quality of Recovery-15 Patient Survey
기간: Patients will be followed for the duration of hospital stay, expected average of 3 days.
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Survey asking 15 questions with regard to how the patient is feeling scored on a scale from 0-10, with 0 being none of the time and 10 being all of the time.
Possible scores range from 0-150, and scores with a higher value indicate a better outcome.
Each subject was administered a baselineQoR-15 survey prior to surgery, and then one on postoperative days (POD) 1 and 2. If a subject was discharged prior to POD2, they were not given a QoR-15 survey that day.
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Patients will be followed for the duration of hospital stay, expected average of 3 days.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Length of Hospital Stay
기간: Participants will be followed for the duration of hospital stay, expected average of 3 days.
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Monitoring the length of hospital stay after undergoing surgery
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Participants will be followed for the duration of hospital stay, expected average of 3 days.
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Hospital Costs
기간: Costs incurred during hospital stay, expected average of 3 days.
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Accessing billing codes/hospital costs for each enrolled subject from the time they are admitted until they are discharged from the hospital.
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Costs incurred during hospital stay, expected average of 3 days.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Peter A Goldstein, MD, Weill Medical College of Cornell University
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1503016056
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Placebo에 대한 임상 시험
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AJU Pharm Co., Ltd.OM Pharma SA모병
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University Hospital, Strasbourg, France모집하지 않고 적극적으로