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

NCT05570292 | Completed Phase 3

• 1 other identifier: FMASU MS210/2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 (

Conditions

Gastric Residual Volume

Outcome Measures

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

  first 2 hours preoperative

Study Arms (2)

Domperidone

ACTIVE COMPARATOR

Drug: Domperidone

Folic acid

PLACEBO COMPARATOR

Drug: Folic acid

Interventions

Domperidone DRUG

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

Domperidone

Folic acid DRUG

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

Folic acid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Domperidone; Folic Acid

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pterins; Pteridines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 6, 2022
• Study Start: October 10, 2022
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

EG (1)