CClinicalTrials.gg
Status unknownNCT04833530Updated Apr 6, 2021

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

An observational study in Ultrasonography, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2021-04-06.

Sponsored by Rabin Medical Center · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 120 Years
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Ultrasonography
03

In context

Lead sponsor

Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  1. Women with BMI >40
  2. Women with diabetes
  3. Women who have previously undergone gastric surgery
  4. Women with language barriers.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Woman undergoing an gastric ultrasound assessment.

    Woman undergoing general anesthesia for oocyte retrieval during in vitro fertilization, will undergo an gastric ultrasound assessment.

    Diagnostic Test: Gastric Ultrasound

Interventions

  • Diagnostic testGastric 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.

06

What researchers measure

Primary outcomes

  1. Preoperative gastric ultrasound measurement

    Time frame: Within 24 hours before Oocyte pickup

  2. Post-anesthesia gastric ultrasound measurement

    Time frame: During Oocyte pickup 1 hour

07

Study locations

1 site
  • Beilinson hospital
    Petach tikvah, Israel
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04833530
Lead sponsor
Rabin Medical Center
Responsible party
Sponsor
First posted
Apr 6, 2021
Start date
Apr 1, 2021 (estimated)
Primary completion
Apr 1, 2022 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
Apr 6, 2021

Study contacts

Sharon Orbach-Zinger
Contact
sharonorbach@yahoo.com
972 54-538-3093
Atara Davis
Contact
ataratdavis@gmail.com
972533321329
Sharon Orbach-zinger
principal investigator · Rabin Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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