The primary objective is to evaluate the effect of continuing GLP-1 RA on gastric volume after standard preoperative fasting in patients using GLP-1 RA for >12 weeks. Additionally, we will evaluate the effect of withholding GLP-1 RA on fasting…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in gastric volume in ml/kg, measured by gastric ultrasound (GU),
between preoperative anaesthesiology visit (GU1, while using GLP-1 RA) and
before surgery (GU2, after withholding GLP-1 RA). Patients are required to fast
before both GU according to the perioperative protocol (6 hours for solids, 2
hours for clear liquids).
Secondary outcome
Difference for the incidence of residual gastric content (RGC), defined as
>1.5ml/kg fluids or presence of solids, between GU2 and GU1.
Difference in fasting blood glucose concentration comparing GU2 and GU1.
Background summary
There is evident success with glucagon-like-peptide-1 receptor agonists (GLP-1
RA) in the treatment for patients with diabetes mellitus type 2 (DM2). However,
GLP-1 RA are also known for their gastric effects, including delayed gastric
emptying. This could lead to increased residual gastric content after
preoperative fasting times, which is why the current standard of care is to
withhold GLP-1 RA for at least one dose before surgery. Stopping GLP-1 RA could
negatively influence patients* blood glucose values resulting in an increased
risk of postoperative complications and lead to logistical problems. It is
argued that after more than 12 weeks of treatment with GLP-1 RA, the concerns
for increased residual gastric content should be minimal as a result of
tolerance and tachyphylaxis, but evidence is lacking.
Study objective
The primary objective is to evaluate the effect of continuing GLP-1 RA on
gastric volume after standard preoperative fasting in patients using GLP-1 RA
for >12 weeks. Additionally, we will evaluate the effect of withholding GLP-1
RA on fasting blood glucose values.
Study design
A self-controlled, non-inferiority study.
Study burden and risks
The burden of this study for participants are minimal, as patients receive two
non-invasive gastric ultrasounds and blood glucose measurements by skilled
professionals. Patients do not change their medication other than following
standard pre-operative guidelines. The fasting on the day of preoperative visit
is expected to have very minimal risks for the participants. There is no
group-related burden, as the design of this study is self-controlled.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Adult patients (>18 years of age)
- Using GLP-1 RA, with a treatment duration over 12 weeks.
- Undergoing planned, elective surgery under general anaesthesia
- Willing and able to provide informed consent, after adherence to standard
preoperative fasting times
Exclusion criteria
- Female who is pregnant or breast-feeding
- Patients with an indication for rapid sequence induction and intubation
(RSII), related to gastric emptying, such as:
o A history of gastroparesis, achalasia, or neuromuscular disorders
o Gastric outlet obstruction
o Hiatus hernia
o History of oesophageal cancer or stricture
o Previous upper gastrointestinal or bariatric surgery
o Ascites
o Small bowel obstruction
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87918.018.25 |
| Other | volgt |