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

Phase 3

Completed

• Conditions: Gastric Residual Volume
• Interventions: Drug: Domperidone; Drug: Folic acid

• Registration Number: NCT05570292
• Lead Sponsor: Ain Shams University

Brief 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 (

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-02
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-06
• Study Start: 2022-10-10
• Primary Completion: 2023-04-20
• Study Completion: 2023-04-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Domperidone	Domperidone	-
Folic acid	Folic acid	-

Primary Outcome Measures

Name	Time	Method
assess the effect of oral Domperidone preoperatively on gastric residual volume by ultrasound for patients undergoing elective surgeries under general anesthesia	first 2 hours preoperative	patients will receive 400 ml of apple juice as a clear fluid, two hours preoperatively, and oral Domperidone tab or placebo tab

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt