Effect of Two Different Doses of Neostigmine on the Gastric Residual Volume and Aspiration in Critically Ill Patients (Gastric)

November 11, 2024 updated by: Zulekha Hospitals

Effect of Two Different Doses of Neostigmine on the Gastric Residual Volume and Aspiration in Critically Ill Patients Under Enteral Feeding; a Comparative Controlled Randomized Trial

A study comparing the effect of two doses of neostigmine on the gastric residual volume in critically ill patients on enteral feeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants were categorized into three groups: Group I and Group II received neostigmine 1 mg and 2 mg, respectively, and a control group received 10 ml of normal saline. All participants received an intravenous administration of 10 mg of metoclopramide. GRV was measured every 3 hours before enteral feeding. aspiration through nasogastric (NG) or orogastric (OG) tubes was done before the next due bolus of feeding.

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12546
        • Al-Azhar Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study included 124 patients aged between 20 and 60 years requiring enteral feeding via nasogastric (NG) or orogastric (OG) tubes

Description

Inclusion Criteria:

  • patients with a GRV >120ml
  • a normal heart rateExclusion Criteria
  • absence of comorbidities such as diabetes and renal failure. exclusion Criteria:
  • Patients exhibiting new-onset arrhythmias or heart block
  • hypotension (systolic blood pressure less than 60 mmHg)
  • experiencing active gastrointestinal bleeding or receiving prokinetic medications 8-12 hours before the intervention
  • patients with a history of surgery in the gastrointestinal system in the past two weeks history of extrapyramidal manifestations
  • patients with electrolyte imbalance
  • pregnant patients,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I
received neostigmine 1 mg
Drug: Neostigmine
two groups (Group I, n= 41) and (Group II, n= 43) received varying doses of neostigmine (1 mg and 2 mg respectively
Group II
received neostigmine 2 mg
Drug: Neostigmine
two groups (Group I, n= 41) and (Group II, n= 43) received varying doses of neostigmine (1 mg and 2 mg respectively
Group III
received normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The risk of aspiration
Time Frame: december 2022 to may 2024
The risk of aspiration in ICU patients on enteral feeding via vaso-gastric or oro-hastric tubes
december 2022 to may 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zulekha Hospitals

Investigators

  • Principal Investigator: abdalla e hassan, lecturer, Lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

November 10, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Estimated)

November 13, 2024

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 382/46

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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