The Effect of Preoperative Anxiety, on Gastric Antrum Size in Women Undergoing in Vitro Fertilization

• Conditions: Ultrasonography
• Interventions: Diagnostic Test: Gastric Ultrasound

• Registration Number: NCT04833530
• Lead Sponsor: Rabin Medical Center

Brief Summary

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.

Detailed Description

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.

At the end of the procedure, the gastric ultrasound circumference will be measured again.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-20
• Study Start: 2021-04-01
• Study First Submitted QC: 2021-04-04
• Last Update Submitted: 2021-04-04
• Study First Posted: 2021-04-06
• Last Update Posted: 2021-04-06
• Primary Completion: 2022-04-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

1. Women with BMI >40
2. Women with diabetes
3. Women who have previously undergone gastric surgery
4. Women with language barriers.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Woman undergoing an gastric ultrasound assessment.	Gastric Ultrasound	Woman undergoing general anesthesia for oocyte retrieval during in vitro fertilization, will undergo an gastric ultrasound assessment.

Primary Outcome Measures

Name	Time	Method
Preoperative gastric ultrasound measurement	Within 24 hours before Oocyte pickup
Post-anesthesia gastric ultrasound measurement	During Oocyte pickup 1 hour

Trial Locations

Locations (1)

Beilinson hospital; 🇮🇱 Petach tikvah, Israel