Evaluation of Gastric Content of Volunteers Fasting and Using Semaglutide: an Observational and Cross-sectional Study

NCT06154486 | Completed DMC FDA Drug

• 1 other identifier: 69273023.7.0000.0071
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Medicines with peptide-1 receptor agonist action similar to glucagon (GLP-1) are a modern therapeutic option for obesity and diabetes mellitus. Semaglutide is a representative of this class medication whose mechanism of action can result in the slowing of gastric emptying and reduced gastric motility, a scenario that can increase the risk of pulmonary aspiration in individuals undergoing anesthesia and despite adequate fasting. Given the severity of the occurrence of bronchoaspiration, the action biological analysis of GLP-1 analogues on gastric function and incremental use of these medications, through gastric ultrasound, we will aim to evaluate the gastric contents of volunteers who do not have risk factors for bronchoaspiration, who will not undergo anesthesia, but are with the fasting recommended for this purpose and are using semaglutide, an analogue of GLP-1. Our hypothesis is that the majority of individuals using these medications have a full stomach even during fasting times recommended in the literature. In view of this, for this population we must adapt safety criteria during the anesthetic procedure.

Conditions

Pneumonia, Aspiration; Anesthesia

Keywords

gastric ultrasound; GLP-1 receptor agonists

Outcome Measures

Primary Outcomes (1)

• prevalence of full stomach after fasting for at least 8 hours

  Compare the prevalence of a full stomach, after fasting for at least 8 hours for solids and 2 hours for clear liquids, through gastric ultrasound in volunteers using semaglutide with those who do not use the medication. The outcome will be binary: a full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 1.5ml/kg. It will be considered an empty stomach when no content or clear liquids are visible inferior to 1.5ml/kg.

  1 day

Secondary Outcomes (3)

• demographic distribution

  1 day

• medication information

  1 day

• Incidence of symptoms associated with medication use

  1 day

Study Arms (2)

semaglutide group

patients without risk factors for gastroparesis, fasting for at least 8 hours, BMI less than 30 and currently using semaglutide

Drug: semaglutide use

control group

patients without risk factors for gastroparesis, fasting for at least 8 hours, BMI less than 30 and who have never used semaglutide or another GLP-1 analogue

Interventions

semaglutide use DRUG

patient using semaglutide for at least 7 days

Also known as: control group

semaglutide group

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

30 volunteers will be included in the study, of which 15 must be currently using semaglutide and 15 must not be using the medication. The gastric ultrasonography will be performed at Hospital Israelita Albert Einstein, in the radiologist medicine sector, by an anesthesiologist with experience in gastric ultrasonography. The images will be registered in the picture archiving and communication system and reviewed by a radiologist.

You may qualify if:

• Adult individuals (aged 18 or over).
• Individuals currently using semaglutide.
• Individuals fasting for at least 8 hours for solids and 2 hours for clear liquids without residue.

You may not qualify if:

• Pregnant women and postpartum women.
• Individuals with technical limitations to perform gastric content assessment using ultrasonography
• Presence of risk factors for gastroparesis.
• Use of drugs from the prokinetic class, which accelerate gastric emptying, such as bromopride, metoclopramide and domperidone.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652900, Brazil

Location

Related Publications (9)

• Kalra S, Bhattacharya S, Kapoor N. Contemporary Classification of Glucagon-Like Peptide 1 Receptor Agonists (GLP1RAs). Diabetes Ther. 2021 Aug;12(8):2133-2147. doi: 10.1007/s13300-021-01113-y. Epub 2021 Jul 15.

  PMID: 34268675 BACKGROUND

• Halawi H, Khemani D, Eckert D, O'Neill J, Kadouh H, Grothe K, Clark MM, Burton DD, Vella A, Acosta A, Zinsmeister AR, Camilleri M. Effects of liraglutide on weight, satiation, and gastric functions in obesity: a randomised, placebo-controlled pilot trial. Lancet Gastroenterol Hepatol. 2017 Dec;2(12):890-899. doi: 10.1016/S2468-1253(17)30285-6. Epub 2017 Sep 27.

  PMID: 28958851 BACKGROUND

• Almustanyir S, Alhabeeb H, AlHusseini N, Al Thow M. Gastroparesis With the Initiation of Liraglutide: A Case Report. Cureus. 2020 Nov 28;12(11):e11735. doi: 10.7759/cureus.11735.

  PMID: 33403167 BACKGROUND

• Warner MA, Meyerhoff KL, Warner ME, Posner KL, Stephens L, Domino KB. Pulmonary Aspiration of Gastric Contents: A Closed Claims Analysis. Anesthesiology. 2021 Aug 1;135(2):284-291. doi: 10.1097/ALN.0000000000003831.

  PMID: 34019629 BACKGROUND

• Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.

  PMID: 28045707 BACKGROUND

• Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.

  PMID: 29624530 BACKGROUND

• Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.

  PMID: 19512861 BACKGROUND

• Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available.

  PMID: 25951832 BACKGROUND

• Bolondi L, Bortolotti M, Santi V, Calletti T, Gaiani S, Labo G. Measurement of gastric emptying time by real-time ultrasonography. Gastroenterology. 1985 Oct;89(4):752-9. doi: 10.1016/0016-5085(85)90569-4.

  PMID: 3896910 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Aspiration

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• veronica fialho

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: December 4, 2023
• Study Start: June 19, 2023
• Primary Completion: June 19, 2023
• Study Completion: August 22, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-09

Locations

BR (1)