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

Ultrasonography Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04833530
• Other study ID #: 0010-21
• Status: Not yet recruiting
• Start date: April 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2021
• Source: Rabin Medical Center
• Contact: Sharon Orbach-Zinger
• Phone: 972 54-538-3093
• Email: sharonorbach[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ultrasonography

Intervention

Diagnostic Test:
• Gastric Ultrasound
In the operating room, a gastric ultrasound will be performed in the supine position and the antral cross sectional area will be measured. 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.

Locations

Country	Name	City	State
Israel	Beilinson hospital	Petach tikvah

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative gastric ultrasound measurement		Within 24 hours before Oocyte pickup
Primary	Post-anesthesia gastric ultrasound measurement		During Oocyte pickup 1 hour