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Clinical Trials/NCT05570292
NCT05570292
Completed
Phase 3

Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries: Prospective , Randomized ,Double Blinded Controlled Study

Ain Shams University1 site in 1 country40 target enrollmentOctober 10, 2022

Overview

Phase
Phase 3
Intervention
Domperidone
Conditions
Gastric Residual Volume
Sponsor
Ain Shams University
Enrollment
40
Locations
1
Primary Endpoint
assess the effect of oral Domperidone preoperatively on gastric residual volume by ultrasound for patients undergoing elective surgeries under general anesthesia
Status
Completed
Last Updated
2 years ago

Overview

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 (

Registry
clinicaltrials.gov
Start Date
October 10, 2022
End Date
April 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amin Mohammed Alansary Amin Ahmed Helwa

Assistant professor

Ain Shams University

Eligibility Criteria

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).

Arms & Interventions

Domperidone

Intervention: Domperidone

Folic acid

Intervention: Folic acid

Outcomes

Primary Outcomes

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

Time Frame: 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

Study Sites (1)

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