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

A

Ain Shams University

Status and phase

Completed
Phase 3

Conditions

Gastric Residual Volume

Treatments

Drug: Domperidone
Drug: Folic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT05570292
FMASU MS210/2022

Details and patient eligibility

About

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 (

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

Domperidone
Active Comparator group
Treatment:
Drug: Domperidone
Folic acid
Placebo Comparator group
Treatment:
Drug: Folic acid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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