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semaglutide glp 1 agonist rct 2025-12 ClinicalTrials

Itopride to Combat Semaglutide-Induced Gastroparesis Before Anesthesia

Effect of Itopride on Semaglutide Gastroparesis

Background

Semaglutide, a widely used medication for type 2 diabetes and obesity, is known to delay gastric emptying, a condition called gastroparesis. This delay can significantly increase the risk of pulmonary aspiration (inhaling stomach contents) during general anesthesia, posing a serious safety concern for patients undergoing surgery. This Phase 4 randomized controlled trial aims to evaluate if the prokinetic agent Itopride can effectively enhance gastric emptying and reduce residual gastric contents in Semaglutide users prior to anesthesia.

Study Design

Population
Patients on Semaglutide for type 2 diabetes and obesity undergoing anesthesia.
Intervention
Itopride, dose and route not specified, prior to anesthesia.
Comparator
Placebo.
Outcome
Reduction in residual gastric contents and improvement in gastric emptying rates, quantified via ultrasound.

Results

This ongoing Phase 4 trial aims to demonstrate that Itopride can significantly mitigate Semaglutide-induced gastroparesis. Researchers hypothesize that patients receiving Itopride will exhibit reduced residual gastric contents compared to the placebo group. The study's primary objective is to quantify a significant reduction in gastric volume via ultrasound in the Itopride arm, thereby decreasing the risk of aspiration during anesthesia. Specifically, they anticipate a measurable improvement in gastric emptying rates, potentially allowing for safer and more timely surgical procedures for individuals on Semaglutide. The trial seeks to provide concrete data on the efficacy of Itopride as a preventative measure.

Why It Matters

The potential for Semaglutide to cause delayed gastric emptying presents a substantial challenge for surgical planning and patient safety, particularly concerning anesthesia risks. If successful, this study could establish a clear protocol for managing Semaglutide users undergoing surgery, potentially preventing life-threatening aspiration events. This research could lead to new clinical guidelines for pre-operative management of patients on GLP-1 receptor agonists, ensuring safer surgical outcomes. Future steps would involve integrating these findings into widespread clinical practice and potentially exploring optimal dosing or alternative prokinetics.


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Source: clinicaltrials:NCT07254715 · Ingested 2026-04-28 · Digest: gemini-2.5-flash