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临床试验/NCT04833530
NCT04833530Unknown不适用

The Effect of Preoperative Anxiety, Extent of Ovarian Stimulation, and Positive Pressure Ventilation on Gastric Antrum Size in Women Undergoing Oocyte Pickup for in Vitro Fertilization Under General Anaesthesia.

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Preoperative gastric ultrasound measurement

研究概览

简要总结

Pulmonary aspiration is one of the most serious risks of general anesthesia and has been reported to occur in as many as 1 in 4000 cases of general anesthesia. Gastric ultrasound is an emerging point-of-care tool that provides bedside information on gastric content and volume.

There have been a few factors which are thought to increase gastric size. Delayed gastric emptying such as caused by gastroparesis in Diabetes Mellitus is an example. Certain surgeries also cause gastroparesis. Other preoperative factors including pain, preoperative anxiety, and blood levels of estradiol or progesterone are less well studied.

详细描述

Women will be recruited before undergoing the procedure.

Upon signed informed consent, women will be asked to rank their anxiety level on a scale of 0-10 (Verbal Numeric Anxiety Score). This scale has been used for previous studies to assess anxiety (Orbach-Zinger, Danon)

In the operating room, a gastric ultrasound will be performed in the supine position and the antral cross sectional area will be measured. This study is purely observational, the gastric ultrasound assessment is non-invasive and will not cause any adverse effects or discomfort to the patient. Participation in the study will not affect clinical management in any way.

Each one of the ultrasound assessments will be performed by one of the study's' investigators.

Anesthesia will be induced in standard procedure and positive pressure will be instituted according to the standard protocol accepted in our hospital.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Woman aged 18 and above undergoing general anesthesia for oocyte retrieval during in vitro fertilization with the ability to sign an informed consent.

排除标准

  • Women with BMI >40
  • Women with diabetes
  • Women who have previously undergone gastric surgery
  • Women with language barriers.

结局指标

主要结局

Preoperative gastric ultrasound measurement

时间窗: Within 24 hours before Oocyte pickup

Post-anesthesia gastric ultrasound measurement

时间窗: During Oocyte pickup 1 hour

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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