Ignite Creation Date:
2024-07-17 @ 11:09 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500143
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Residual Gastric Content After Holding of Glucagon-like Peptide-1 Receptor Agonists Before Elective Surgery
Sponsor:
Ciusss de LEst de lÎle de Montréal
Organization:
Ciusss de LEst de lÎle de Montréal
Study Overview
Official Title:
The RESIDUAL Study Residual Gastric Content After Holding of Glucagon-like Peptide-1 Receptor Agonists Before Elective Surgery a Cross-sectional Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
RESIDUAL
Brief Summary:
Glucagon-like peptide-1 agonists GLP-1RA are a family of medications used for diabetes and weight loss One of their effect is to slow down stomach emptying The goal of this study is to evaluate the effect of GLP-1RA on the effectiveness of fasting before a scheduled surgery
The question it aims to answer is does this kind of medication increase the risk of having food or too much liquid in the stomach before a scheduled surgery even if the minimum 6 hour fast is done
For this project researchers will use gastric ultrasound to compare participants already taking one of these medications as part of their home treatment to participants who are not taking them Gastric ultrasound is a simple bedside exam using an echography machine that takes less than 5 minutes to do
Participants will
-Have a gastric ultrasound performed on them before their surgery
The question it aims to answer is does this kind of medication increase the risk of having food or too much liquid in the stomach before a scheduled surgery even if the minimum 6 hour fast is done
For this project researchers will use gastric ultrasound to compare participants already taking one of these medications as part of their home treatment to participants who are not taking them Gastric ultrasound is a simple bedside exam using an echography machine that takes less than 5 minutes to do
Participants will
-Have a gastric ultrasound performed on them before their surgery
Detailed Description:
Background Glucagon-like peptide-1 receptor agonists GLP-1RA are glucose-lowering drugs that act through three mechanisms stimulation of insulin secretion inhibition of glucagon secretion and decrease of gastric emptying The GLP-1RA are now an important part of glycemic control in type 2 diabetes mellitus T2DM Recently GLP-1 RA have received approval for weight loss expanding their use in overweight or obese non-diabetic patientsThe effect of GLP-1RA on decreased gastric emptying has long been established but he clinical implication of this in the periprocedural setting is uncertain Recent guidelines recommend holding the weekly-dosed for at least a week before elective surgery Considering the extended half-lives of once-weekly GLP-1RA approximately 6 days for semaglutide and 5 days for dulaglutide it is unclear if following those guidelines is sufficient to make sure patients are not at high risk of aspiration
Hypothesis This study will compare ultrasound-assessed residual gastric content RGC between once-weekly GLP-1RA users that stopped their medication for 7 days or more before elective surgery and patients not taking GLP-1RA The investigators hypothesized that even with appropriate holding of GLP-1RA those patients may have increased RGC and be at higher risk of aspiration
Objectives
Primary objective
To investigate the relation between GLP-1RA use and increased RGC
Secondary objectives
To assess the relation between the number of days since the last dose of GLP-1RA and increased RGC
To assess the relation between the dose of GLP-1RA and RGC
Exploratory objectives
To explore the relation between other known risk factors of gastroparesis and increased RGC
To explore the relation between the time since the last oral intake and increased RGC
Methods A gastric ultrasound GUSwill be performed on all patients to assess RGC using a published validated and reproductible method used in recent trials The acquisition of images will be performed by a blinded anesthesiologist or anesthesiology resident using a dedicated ultrasound machine The images will be saved and reviewed by another blinded trained anesthesiologist
Significanceimportance The results of this study could challenge the actual recommendations for GLP-1RA stoppage before surgery and help improve perioperative care for patients taking GLP-1RA
Hypothesis This study will compare ultrasound-assessed residual gastric content RGC between once-weekly GLP-1RA users that stopped their medication for 7 days or more before elective surgery and patients not taking GLP-1RA The investigators hypothesized that even with appropriate holding of GLP-1RA those patients may have increased RGC and be at higher risk of aspiration
Objectives
Primary objective
To investigate the relation between GLP-1RA use and increased RGC
Secondary objectives
To assess the relation between the number of days since the last dose of GLP-1RA and increased RGC
To assess the relation between the dose of GLP-1RA and RGC
Exploratory objectives
To explore the relation between other known risk factors of gastroparesis and increased RGC
To explore the relation between the time since the last oral intake and increased RGC
Methods A gastric ultrasound GUSwill be performed on all patients to assess RGC using a published validated and reproductible method used in recent trials The acquisition of images will be performed by a blinded anesthesiologist or anesthesiology resident using a dedicated ultrasound machine The images will be saved and reviewed by another blinded trained anesthesiologist
Significanceimportance The results of this study could challenge the actual recommendations for GLP-1RA stoppage before surgery and help improve perioperative care for patients taking GLP-1RA
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