- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03490175
Genetic Variants and Non-genetic Variables and Postoperative Nausea and Vomiting
Genetic Variants and Non-genetic Variables Associated With Postoperative Nausea and Vomiting (PONV)
연구 개요
상세 설명
Background
Surgery and anesthesia are related to unwanted adverse events, side effects and postoperative discomfort. Postoperative nausea and vomiting are frequent and the question arises which patient is at specific risk for these sequelae. Some predisposing factors for PONV are well described, e.g. female sex, non-smoking status and postoperative opioids. Some drugs used for anesthesia as well as surgery related variables might induce PONV.
In this prospective association study patient related variables, surgical and anesthesia related variables as well as genetic variants of several candidate genes will be investigated in a well-described patient cohort presenting for scheduled surgery.
Objective
The aim of this study is to investigate a possible association of non-genetic variables and genetic variants with PONV.
Methods
Prospective association study performed in patients recovering form elective surgery and anesthesia.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Bern, 스위스, 3010
- Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 18 years and older
- Written informed consent
- Elective surgery
Exclusion Criteria
- No written informed consent
- Cognitive impairment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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All patients
Patients undergoing general anesthesia for elective surgery
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Association study: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV
기간: perioperative period up to 48 hours after surgery
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PONV composite outcome measured by episodes of vomiting and nausea + need for antiemetic treatment + results of a patient reported outcome questionnaire.
Patients with no PONV are compared to those with intermediate and severe PONV.
Bariatric patients will not be included in this analysis.
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perioperative period up to 48 hours after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sex specific association analysis: Severity of PONV associated with genetic and non-genetic variables in males and females
기간: perioperative period up to 48 hours after surgery
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PONV composite outcome measured by episodes of vomiting and nausea + need for antiemetic treatment + results of a patient reported outcome.
questionnaire.
Patients with no PONV are compared to those with intermediate and severe PONV
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perioperative period up to 48 hours after surgery
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Association study in patients undergoing bariatric surgery: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV
기간: perioperative period up to 48 hours after surgery
|
PONV composite outcome measured by episodes of vomiting and nausea + need for antiemetic treatment + results of a patient reported outcome questionnaire.
Patients with no PONV are compared to those with intermediate and severe PONV
|
perioperative period up to 48 hours after surgery
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ulrike M Stamer, MD, Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
- 연구 의자: Ulrike Stamer, Prof. MD, Department of Anaestheisology and Pain Medicine, Inselspital, University of Bern
간행물 및 유용한 링크
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
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 041/09b PONV
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