- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07623148
GLP-1 RA Cessation and Gastric Ultrasound Findings
Time-dependent Association Between Cessation of Glucagon-like Peptide-1 Receptor Agonists and Residual Gastric Contents Assessed by Point-of-care Gastric Ultrasound: a Prospective Observational Study
연구 개요
상세 설명
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are increasingly used for the treatment of type 2 diabetes and obesity. These agents can delay gastric emptying, raising concerns about residual gastric contents and potential aspiration risk during anesthesia. Current perioperative recommendations regarding GLP-1 RA discontinuation are largely consensus-based, and the physiological relationship between cessation interval and residual gastric content remains insufficiently defined.
This single-center prospective observational cohort study will enroll adult patients who are receiving GLP-1 RAs and are scheduled for elective non-cardiac surgery requiring general anesthesia. GLP-1 RA management will follow usual clinical care; the study team will not assign, modify, or instruct the timing of drug discontinuation. The primary exposure will be the number of days since the last GLP-1 RA dose, analyzed both as a continuous variable and according to prespecified cessation-interval categories.
Immediately before induction of anesthesia, participants will undergo standardized point-of-care gastric ultrasound. Qualitative gastric content will be assessed using the Perlas grading system, and quantitative gastric volume will be estimated from the antral cross-sectional area measured in the right lateral decubitus position. The primary outcome will be estimated gastric volume normalized to body weight. Secondary outcomes will include antral cross-sectional area, Perlas grade, and the presence of high-risk gastric contents.
Multivariable regression models will be used to evaluate the association between GLP-1 RA cessation interval and gastric ultrasound findings after adjustment for clinically relevant covariates, including age, sex, body mass index, diabetes status, preoperative fasting duration, and gastrointestinal symptom score. Body mass index will be evaluated as a prespecified effect modifier.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Jeonbuk-do
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Iksan, Jeonbuk-do, 대한민국, 54538
- Wonkwang University School of Medicine Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adults aged 18 years or older.
- Patients receiving a glucagon-like peptide-1 receptor agonist.
- Patients scheduled for elective non-cardiac surgery requiring general anesthesia.
- Patients able to provide written informed consent.
Exclusion Criteria:
- Emergency surgery.
- History of prior gastric surgery.
- Known gastroparesis or severe gastroesophageal reflux disease.
- Declined or unable to provide written informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Last GLP-1 RA Dose 3 Days or Less
Participants receiving glucagon-like peptide-1 receptor agonists whose last dose was taken 3 days or less before elective surgery.
No intervention was assigned by the study protocol; GLP-1 RA management followed usual clinical care.
Participants underwent preoperative point-of-care gastric ultrasound to assess residual gastric contents.
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Observed exposure defined as the number of days between the participant's last glucagon-like peptide-1 receptor agonist dose and elective surgery.
Participants were categorized according to time since last dose: 3 days or less, 4 to 7 days, and 8 days or more.
No GLP-1 receptor agonist was assigned, administered, continued, or discontinued by the study protocol; medication management followed usual clinical care.
다른 이름들:
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Last GLP-1 RA Dose 4 to 7 Days
Participants receiving glucagon-like peptide-1 receptor agonists whose last dose was taken 4 to 7 days before elective surgery.
No intervention was assigned by the study protocol; GLP-1 RA management followed usual clinical care.
Participants underwent preoperative point-of-care gastric ultrasound to assess residual gastric contents.
|
Observed exposure defined as the number of days between the participant's last glucagon-like peptide-1 receptor agonist dose and elective surgery.
Participants were categorized according to time since last dose: 3 days or less, 4 to 7 days, and 8 days or more.
No GLP-1 receptor agonist was assigned, administered, continued, or discontinued by the study protocol; medication management followed usual clinical care.
다른 이름들:
|
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Last GLP-1 RA Dose 8 Days or More
Participants receiving glucagon-like peptide-1 receptor agonists whose last dose was taken 8 days or more before elective surgery.
No intervention was assigned by the study protocol; GLP-1 RA management followed usual clinical care.
Participants underwent preoperative point-of-care gastric ultrasound to assess residual gastric contents.
|
Observed exposure defined as the number of days between the participant's last glucagon-like peptide-1 receptor agonist dose and elective surgery.
Participants were categorized according to time since last dose: 3 days or less, 4 to 7 days, and 8 days or more.
No GLP-1 receptor agonist was assigned, administered, continued, or discontinued by the study protocol; medication management followed usual clinical care.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Estimated Gastric Volume Normalized to Body Weight
기간: Immediately before induction of anesthesia on the day of surgery
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Estimated gastric volume normalized to body weight, expressed as mL/kg, calculated from the antral cross-sectional area measured by preoperative point-of-care gastric ultrasound in the right lateral decubitus position.
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Immediately before induction of anesthesia on the day of surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Antral Cross-Sectional Area
기간: Immediately before induction of anesthesia on the day of surgery
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Antral cross-sectional area measured by preoperative point-of-care gastric ultrasound in the right lateral decubitus position and expressed in cm2.
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Immediately before induction of anesthesia on the day of surgery
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Perlas Gastric Ultrasound Grade
기간: Immediately before induction of anesthesia on the day of surgery
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Qualitative gastric content assessed using the Perlas grading system.
Grade 0 indicates an empty stomach, Grade 1 indicates fluid visible only in the right lateral decubitus position, and Grade 2 indicates fluid visible in both supine and right lateral decubitus positions.
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Immediately before induction of anesthesia on the day of surgery
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Gastrointestinal Symptom Score
기간: Within 24 hours before surgery
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Preoperative gastrointestinal symptom score assessing nausea, vomiting, bloating, early satiety, and abdominal discomfort.
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Within 24 hours before surgery
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공동 작업자 및 조사자
수사관
- 연구 책임자: Cheol Lee, M.D.,Ph.D, Wonkwang University Hosptial
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 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. .
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