NCT04833530

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

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ultrasonography

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-04-01
• Completion: 2022-12-01
• First posted: 2021-04-06
• Last updated: 2021-04-06

Locations

1 site across 1 country: Israel