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临床试验/CTRI/2026/02/103288
CTRI/2026/02/103288尚未招募不适用

Comparison of Fasting Gastric Volume in different Phases of Menstrual Cycle and Correlation with Hormonal Levels: A Prospective Observational Study Protocol

All India Institute of Medical Sciences New Delhi1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2027年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
88
试验地点
1

研究概览

简要总结

Pulmonary aspiration remains a serious perioperative complication, particularly in patients with full stomachs. Gastric ultrasonography (USG) serves as a reliable, non-invasive bedside tool to estimate gastric volume and contents, helping assess aspiration risk. Existing research indicates that gastric emptying and motility may be influenced by hormonal changes during different phases of the menstrual cycle, mediated through oestrogen and progesterone effects on smooth muscle tone and nitric oxide synthase pathways. However, the literature presents conflicting findings—some studies report faster gastric emptying in the luteal phase, while others document delayed emptying. Given this inconsistency, the proposed study aims to evaluate the effect of menstrual cycle phase (follicular vs. luteal) on fasting gastric volume in healthy female subjects using point-of-care gastric ultrasonography. The goal is to determine whether hormonal variations across the cycle have clinically relevant implications for preoperative fasting guidelines and aspiration risk assessment in women.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Regular menstrual cycles,
  • ASA classes 1 and 2,
  • Consenting to participate.

排除标准

  • Irregular menstrual cycle Hormone replacement therapy Polycystic ovarian syndrome (PCOS) Diabetes mellitus, Gastroesophageal reflux disease, Chronic kidney disease, Body mass index more than 30 Pregnancy, Medications affecting gastric motility, Upper abdominal surgery history, Postmenopausal status, Hormonal contraception use, Emergency surgery.

研究者

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Amit kumar

AIIMS, New Delhi

研究点 (1)

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