The Effect of Preoperative Anxiety, on Gastric Antrum Size in Women Undergoing in Vitro Fertilization
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedFirst Posted
Study publicly available on registry
April 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedApril 6, 2021
March 1, 2021
1 year
March 20, 2021
April 4, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Preoperative gastric ultrasound measurement
Within 24 hours before Oocyte pickup
Post-anesthesia gastric ultrasound measurement
During Oocyte pickup 1 hour
Study Arms (1)
Woman undergoing an gastric ultrasound assessment.
Woman undergoing general anesthesia for oocyte retrieval during in vitro fertilization, will undergo an gastric ultrasound assessment.
Interventions
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.
Eligibility Criteria
Woman aged 18 and above undergoing general anesthesia for oocyte retrieval during in vitro fertilization with the ability to sign an informed consent.
You may qualify if:
- Woman aged 18 and above undergoing general anesthesia for oocyte retrieval during in vitro fertilization with the ability to sign an informed consent.
You may not qualify if:
- Women with BMI \>40
- Women with diabetes
- Women who have previously undergone gastric surgery
- Women with language barriers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beilinson hospital
Petach Tikvah, Israel
Related Publications (1)
Azem K, Orbach-Zinger S, Heesen P, Finkelstein A, Eidelman LA, Shufaro Y, Arzola C. The effect of preoperative anxiety and ovarian stimulation on gastric antrum size: a prospective observational study. J Psychosom Obstet Gynaecol. 2023 Dec;44(1):2170226. doi: 10.1080/0167482X.2023.2170226.
PMID: 36774546DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Orbach-zinger
Rabin Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2021
First Posted
April 6, 2021
Study Start
April 1, 2021
Primary Completion
April 1, 2022
Study Completion
December 1, 2022
Last Updated
April 6, 2021
Record last verified: 2021-03