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临床试验/NCT05570292
NCT05570292已完成3 期

Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries: Prospective , Randomized ,Double Blinded Controlled Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年10月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
40
试验地点
1
主要终点
assess the effect of oral Domperidone preoperatively on gastric residual volume by ultrasound for patients undergoing elective surgeries under general anesthesia

研究概览

简要总结

General Anesthesia requires preoperative fasting according to specific instructions. Regarding Fasting Guidelines, The American Society of Anesthesiologists (ASA) recommends patients to fast from fatty food or meat eight hours prior to surgery, non-human milk or light meal for six hours prior, breast milk for four hours prior, and clear liquids including water, pulp-free juice, and tea without milk for two hours prior to the anesthetic. ASA fasting guidelines application represents the primary method to avoid aspiration as it ensures that stomach is empty before induction of anesthesia. These guidelines cannot be applied on all cases as in urgent or emergent situations or in morbidities associated with delayed gastric emptying, like Diabetes mellitus and some neurological disorders (

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both sexes
  • aged between 18-65 years
  • who are categorized by ASA physical status as I or II
  • undergoing elective surgeries under general anesthesia

排除标准

  • Patients with known or suspected delayed gastric emptying (e.g. Diabetes mellitus) -psychiatric disorders
  • hypersensitivity to the study medications
  • peoples undergoing surgeries that associated with high incidence of Post operative nausea and vomiting (PONV) (e.g. Cholecystectomy, gynecological, ophthalmological, otorhinolaryngological, and laparoscopic surgeries).

研究组 & 干预措施

Domperidone

Active Comparator

干预措施: Domperidone (Drug)

Folic acid

Placebo Comparator

干预措施: Folic acid (Drug)

结局指标

主要结局

assess the effect of oral Domperidone preoperatively on gastric residual volume by ultrasound for patients undergoing elective surgeries under general anesthesia

时间窗: first 2 hours preoperative

patients will receive 400 ml of apple juice as a clear fluid, two hours preoperatively, and oral Domperidone tab or placebo tab

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amin Mohammed Alansary Amin Ahmed Helwa

Assistant professor

Ain Shams University

研究点 (1)

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