Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388213
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-23
Brief Title:
Investigation of the Evolution of Gastric Emptying by Gastric Ultra Sonography in Patients Treated With GLP-1 Receptor Agonists on a 7 Days Pausing Period
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Investigation of Gastric Emptying in Patients Treated With GLP-1 Receptor Agonists
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
Glucagon-like-peptide-1 is a hormone released by the gut enteroendocrine cells Its secretion occurs after each meal to enable production of insulin and inhibits the production of glucagon to lower after meal glycemia It also inhibits gastric emptying and food intake GLP-1 RA plays a role on GLP-1 receptors present on islet beta cells and delta cells of the pancreas to control insulin GLP-1 receptors are also present in multiple region of the central nervous system such as the hypothalamus and hindbrain where it results in reducing food intake For anesthesiologist it is important to understand how GLP-1 RA influence gastric emptying Indeed respecting a fasting period 6 hours for solid and 2 hours for liquid before each surgery is one of the cornerstones of anesthesiology to significantly reduce the risk of pulmonary aspiration One of the side effects of GLP-1 RA is slowing gastric emptying and increasing the risk of regurgitation in patient that observed a recommended fasting period During 2023 a lot of cases reports have emerged of pulmonary aspiration or the presence of a full stomach in patient treated by GLP-1 RA for a type 2 diabetes Despite recommendations made by the American Society of Anesthesiology it is still unkown what is the best fasting period and how long patients should pause a long acting GLP-1 RA before surgery In this observational study we would like to determine the effect of GLP-1 RA on gastric emptying in patient scheduled for general anesthesia We will measure and compare residual gastric content with gastric ultrasonography in patients treated by GLP-1 RA and in those who are not We will also do these comparisons in a group of patients with type 2 diabetes treated by weekly GLP-1 RA at different days after the injection of the medication Our hypothesis is that we will observe a reduction in gastric residue in patients who stopped weekly GLP-1 RA 7 days prior the examination compared to those who have stopped less days considering the same fasting period This would lead us to propose an optimal duration of stopping time for GLP-1 inhibitors in the preoperative period
Detailed Description:
The study design consists in a prospective monocentric observational study comparing 2 groups of patients either treated by GLP-1 RA more than 3 months or without GLP-1 RA treatment The investigators will perform a gastric echography in both groups to define gastric residue after a fasting period of at least 6 hours for solids and 2 hours for liquids Patients will have free access to any eating regimen before fasting The instructions given to patients will be to stop eating solids 6h and drinking 2h before investigation Patients will also fill a nutrition booklet which will be analyzed by a nutritionist nurse thereafter The investigations will be performed at 24h 48h 96h and 144h after last injection of GLP-1 RA in the investigation group and only once in the control group Gastric echography will be realized using curved ultrasonic probe placed in sagittal plane on the epigastric area under xyphoid appendix and upper to the umbilicus Visualization of left hepatic lobe antrum aorta and upper mesenteric artery will assess good position of the ultrasonic probe Qualitative observation of antrum will be made to assess antrum volume in recumbent position A qualitative and quantitative analyze will be performed in right lateral decubitus by measuring atrum cross-sectional area CSA Following formula will be used to determine volume of the antrum Volume mL 270 146 9 x right-lat CSA - 128 x age A full stomach will be considered when solids are observed or if gastric volume is superior to 15 mlkg An empty stomach is defined when gastric volume is inferior to 15 mlkg Gastric echography is proceeded by two anesthetists who will be blinded one to the other CSA will be compared between two investigation groups Time-course of CSA and presence of solids or liquids will be assessed at all study time-points up to the seventh day in the investigation group A reduction of 55 cm2 of CSA after one week from last injection of GLP-1 RA will be considered significant Based on a power study it has been evaluated that a sample of 20 patients per group will be necessary to have a power of 80 with an alpha risk of 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None