Clinical trial NCT04833530: The Effect of Preoperative Anxiety, on Gastric Antrum Size in Women Undergoing in Vitro Fertilization
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ultrasonography
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman aged 18 and above undergoing general anesthesia for oocyte retrieval during in vitro fertilization with the ability to sign an informed consent.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Preoperative gastric ultrasound measurement
timeFrame: Within 24 hours before Oocyte pickup
measure: Post-anesthesia gastric ultrasound measurement
timeFrame: During Oocyte pickup 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Petach tikvah
country: Israel
facility: Beilinson hospital
Study officials:
affiliation: Rabin Medical Center
name: Sharon Orbach-zinger
role: PRINCIPAL_INVESTIGATOR
References: