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

Gastric Residual Volume Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05570292
• Other study ID #: FMASU MS210/2022
• Status: Completed
• Phase: Phase 3
• Start date: October 10, 2022
• Est. completion date: April 20, 2023

Study information

• Verified date: May 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Gastric Residual Volume

Intervention

Drug:
• Domperidone
ultrasound guieded assesment of gastric residual volume will be done 2 h after oral injestion of domperidone tablet
• Folic acid
ultrasound guieded assesment of gastric residual volume will be done 2 h after oral injestion of folic acid tablet

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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