- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04879771
Comparison of Receiving Painless Gastrointestinal Endoscopy in the Morning or Afternoon on Postoperative Sleep Quality
Gastrointestinal endoscopy (GIE) are important examinations for screening, diagnosing, and treating a variety of gastrointestinal diseases. Specifically, endoscopy is one of the best surveillance tools for early detection of several cancers, GIE is increasingly being used because of government support for cancer screening and growing interest in preventive medicine. But some patients refuse endoscopic examinations because of fear and anxiety of discomfort during the procedure. Sedatives is increasingly used in GIE these years to reduce the anxiety and discomfort of patients and increase patient satisfaction. Sedatives also minimize the risk of patient injury during GIE and provide ideal working conditions for endoscopists to improve patients' satisfaction with surgery. Sedation can be divided into four levels: minimal sedation (anxiolysis), conscious sedation, deep sedation, and general anesthesia. A combination of benzodiazepines and opiates (midazolam and fentanyl), the medications used most commonly by gastroenterologists for procedural sedation, provides adequate analgesia and sedation during colonoscopy. Besides above, propofol is an intravenously administered hypnotic drug used for induction and maintenance of general anaesthesia and is also used in procedural sedation. Nowadays, propofol sedation is preferred by more and more endoscopists for colonoscopy procedures with its perceived benefits of rapid postprocedure drug clearance, improved patient comfort and rapid recovery/discharge when compared to conventional sedation. And propofol provided more rapid recovery than midazolam, it has the merit of post-procedure neuropsychologic function over midazolam. Previous studies have found that general anesthesia, as an independent risk factor, may lead to desynchronization of the circadian rhythm, which could result in postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow-wave sleep (SWS). Postoperative sleep disorders could cause serious adverse effects on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even increased pain sensitivity or postoperative pain in patients. Previous studies have found that general anesthesia, as an independent risk factor, may lead to desynchronization of the circadian rhythm, which could result in postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow-wave sleep (SWS). Postoperative sleep disorders could cause serious adverse effects on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even increased pain sensitivity or postoperative pain in patients. At present, there are few studies that have assessed the effect of circadian rhythm during different timings of gastrointestinal endoscopy on postoperative sleep quality, and pain under general anesthesia.
Based on these considerations, we sought to answer the questions in this study:
- What is the impact of morning operation and evening operation on the intraoperative anesthetic requirement under general anesthesia?
- What are the effects of different timings of surgery on the postoperative sleep quality and pain under general anesthesia?
연구 개요
상태
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
Liaoning
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Shenyang, Liaoning, 중국, 110004
- 모병
- Shengjing Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- age between 18 and 65 years,
- ASA physical status of I or II.
Exclusion Criteria:
- presence of sleep disorders
- pain syndrome
- cardiovascular disease
- sleep apnea syndrome
- psychosis
- history of opioid usage
- history of abnormal operation or anesthesia recovery
- unwillingness to provide informed consent
- patient with a language communication disorder.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Morning GIE
|
patients receive gastrointestinal endoscopy in the morning or afternoon
|
|
Afternoon GIE
|
patients receive gastrointestinal endoscopy in the morning or afternoon
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
postoperative sleep quality
기간: first night after inspections
|
assess sleep quality by using the Athens insomnia scale Total AIS scores range from 0 to 24 points.
A total score of ≥ 6 points indicates a diagnosis of insomnia
|
first night after inspections
|
|
postoperative sleep quality
기간: second night after inspections
|
assess sleep quality by using the Athens insomnia scale Total AIS scores range from 0 to 24 points.
A total score of ≥ 6 points indicates a diagnosis of insomnia
|
second night after inspections
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
postoperative pain score
기간: 24 hours after surgery
|
assess pain level by using VAS score Postoperative pain scores were evaluated by the visual analog scale (VAS) score,15 where 0 indicates painlessness, and 10 indicates severe pain.
The VAS score was measured at 1, 6, 12, and 24 hours postoperatively
|
24 hours after surgery
|
|
postoperative adverse effects
기간: 24 hours after surgery
|
assess postoperative adverse effects
|
24 hours after surgery
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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
기타 연구 ID 번호
- GIE and sleep
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .
통증에 대한 임상 시험
-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
-
Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
-
Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
-
Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)
Receive gastrointestinal endoscopy에 대한 임상 시험
-
Société Française d'Endoscopie Digestive완전한
-
Inje University완전한
-
Johns Hopkins University모집하지 않고 적극적으로