Effect of Itopride on Semaglutide Gastroparesis | NCT07254715

Studies
Effect of Itopride on Semaglutide Gastroparesis

NCT07254715

Sponsor

Ain Shams University

Status

Recruiting

Last Update Posted

Nov 28, 2025Actual

Enrollment

60Estimated

Phase

Phase 4

Conditions

Semaglutide-Induced Gastric Motility
Anesthesia

Interventions

Itopride HCI 50 mg
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2025Estimated

Primary Completion Date

Apr 2026Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Nov 19, 2025

First Submission Date that Met QC Criteria

Nov 25, 2025

First Posted Date

Nov 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2025

Last Update Posted Date

Nov 28, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tamer Samir Abdelsalam, Assistant professor of anesthesia, Intensive care and Pain medicine, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Semaglutide delays gastric emptying and increases the risk of aspiration with anesthesia; So, the addition of prokinetics as Itopride, could enhance gastric emptying and hasten surgery.

The investigator will evaluate the effect of Itopride on Semaglutide-induced gastroparesis and residual gastric contents after 8 hours of fasting by gastric ultrasound before anesthesia.

Detailed Description

Semaglutide delays gastric emptying and increases the risk of aspiration with anesthesia; So, the addition of prokinetics as Itopride could enhance gastric emptying and hastens surgery.

Semaglutide, a glucagon-like peptide-1 (GLP-1) agonist, is gaining popularity for the treatment of type 2 diabetes mellitus (T2DM) and obesity; Semaglutide stimulates insulin excretion and delays gastric emptying.Itopride, a novel prokinetic agent, acts as a dopamine D2 receptor antagonist and an acetylcholine esterase inhibitor. Itopride shows promise in managing gastroparesis symptoms by accelerating gastric emptying, improving gastric tension and sensitivity, and exerting antiemetic effects.

The investigator designed this prospective, randomized, double-blind controlled study to evaluate the effect of Itopride on Semaglutide induced gastroparesis and residual gastric contents after 8-hours fasting by gastric ultrasound before anesthesia.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Itopride HCL	Active Comparator	Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days	Drug: Itopride HCI 50 mg
Placebo	Placebo Comparator	Daily placebo tablet TID, 1 hour before meals for 7 days	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Itopride HCI 50 mg	Drug	Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days	Itopride HCL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Residual gastric contents	Residual gastric contents (clear fluid ˃1.5 mL/kg or the presence of solids) by ultrasound in the right lateral decubitus after 8-hours fasting .	on day 7

Secondary Outcomes

Measure	Description	Time Frame
Residual gastric contents on day 3 and day 5.		on day 3 and day 5
Incidence of vomiting during anesthesia		during anesthesia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists grade I- III.
Age: 40-60 years.
BMI: 20-30 kg/m2.
Diabetic patients on semaglutide (0.5-1mg) SC weekly.
Undergoing elective hysterectomy.

Exclusion Criteria:

Declining to give written informed consent.
history of upper abdominal surgery or the presence of hiatal hernia.
Other medications inducing gastroparesis (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, and lithium).
History of allergy to Itopride.
History of cardiac arrhythmia or abnormal ECG.
Neurologic diseases (including Parkinson's disease and multiple sclerosis)
Hepatic or renal failure.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
tamer Samir abdelaziz, MD	Contact	+201154601505		drtasamir@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
faculty of medicine, Ain Shams University	Recruiting	Cairo	Cairo Governorate	11591	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided