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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-10

Study Completion Date

2023-04-20

Brief Summary

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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 (

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Detailed Description

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Conditions

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Gastric Residual Volume

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Domperidone

Group Type ACTIVE_COMPARATOR

Domperidone

Intervention Type DRUG

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

Folic acid

Group Type PLACEBO_COMPARATOR

Folic acid

Intervention Type DRUG

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

Interventions

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Domperidone

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

Intervention Type DRUG

Folic acid

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

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No