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CompletedNCT05570292Updated May 15, 2023

Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries

A Phase 3 interventional study of Domperidone and Folic acid in Gastric Residual Volume, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-15.

Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

General Anesthesia requires preoperative fasting according to specific instructions. Regarding Fasting Guidelines, The American Society of Anesthesiologists (ASA) recommends patients to fast from fatty food or meat eight hours prior to surgery, non-human milk or light meal for six hours prior, breast milk for four hours prior, and clear liquids including water, pulp-free juice, and tea without milk for two hours prior to the anesthetic. ASA fasting guidelines application represents the primary method to avoid aspiration as it ensures that stomach is empty before induction of anesthesia. These guidelines cannot be applied on all cases as in urgent or emergent situations or in morbidities associated with delayed gastric emptying, like Diabetes mellitus and some neurological disorders (

02

Conditions studied

  • Gastric Residual Volume
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients of both sexes
  • aged between 18-65 years
  • who are categorized by ASA physical status as I or II
  • undergoing elective surgeries under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • Patients with known or suspected delayed gastric emptying (e.g. Diabetes mellitus) -psychiatric disorders
  • hypersensitivity to the study medications
  • peoples undergoing surgeries that associated with high incidence of Post operative nausea and vomiting (PONV) (e.g. Cholecystectomy, gynecological, ophthalmological, otorhinolaryngological, and laparoscopic surgeries).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Domperidone

    Drug: Domperidone

  • Placebo comparator
    Folic acid

    Drug: Folic acid

Interventions

  • DrugDomperidone

    ultrasound guieded assesment of gastric residual volume will be done 2 h after oral injestion of domperidone tablet

  • DrugFolic acid

    ultrasound guieded assesment of gastric residual volume will be done 2 h after oral injestion of folic acid tablet

06

What researchers measure

Primary outcomes

  1. assess the effect of oral Domperidone preoperatively on gastric residual volume by ultrasound for patients undergoing elective surgeries under general anesthesia

    patients will receive 400 ml of apple juice as a clear fluid, two hours preoperatively, and oral Domperidone tab or placebo tab

    Time frame: first 2 hours preoperative

07

Study locations

1 site
  • Ain Shams University hospitals
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05570292
Lead sponsor
Ain Shams University
Responsible party
Amin Mohammed Alansary Amin Ahmed Helwa (Assistant professor, Ain Shams University) — Principal investigator
First posted
Oct 6, 2022
Start date
Oct 10, 2022
Primary completion
Apr 20, 2023
Completion
Apr 20, 2023
Last update
May 15, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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