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

Overview

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.

Full Title of Study: “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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 1, 2022

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.

Interventions

  • 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.

Arms, 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.

Clinical Trial Outcome Measures

Primary Measures

  • Preoperative gastric ultrasound measurement
    • Time Frame: Within 24 hours before Oocyte pickup
  • Post-anesthesia gastric ultrasound measurement
    • Time Frame: During Oocyte pickup 1 hour

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Woman aged 18 and above undergoing general anesthesia for oocyte retrieval during in vitro fertilization with the ability to sign an informed consent.

Minimum Age: 18 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rabin Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sharon Orbach-zinger, Principal Investigator, Rabin Medical Center
  • Overall Contact(s)
    • Sharon Orbach-Zinger, 972 54-538-3093, sharonorbach@yahoo.com

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