Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833530
Status:
UNKNOWN
Last Update Posted:
2021-04-06
First Post:
2021-03-20
Brief Title:
The Effect of Preoperative Anxiety on Gastric Antrum Size in Women Undergoing in Vitro Fertilization
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 studys 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
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 studys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None