NCT06687187

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

1.3 years

First QC Date

November 10, 2024

Last Update Submit

November 11, 2024

Conditions

Gastric Reflux

Outcome Measures

Primary Outcomes (1)

  • The risk of aspiration

    The risk of aspiration in ICU patients on enteral feeding via vaso-gastric or oro-hastric tubes

    december 2022 to may 2024

Study Arms (3)

Group I

received neostigmine 1 mg

Drug: Neostigmine

Group II

received neostigmine 2 mg

Drug: Neostigmine

Group III

received normal saline

Interventions

NeostigmineDRUG

two groups (Group I, n= 41) and (Group II, n= 43) received varying doses of neostigmine (1 mg and 2 mg respectively

Group IGroup II

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • patients with a GRV \>120ml

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar faculty of medicine

Cairo, 12546, Egypt

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Neostigmine

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Phenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • abdalla e hassan, lecturer

    lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2024

First Posted

November 13, 2024

Study Start

December 1, 2022

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

November 13, 2024

Record last verified: 2024-11

Locations

EG(1)