Effects of Neostigmine-dose on Diaphragmatic Dynamics (DTF/DE/AChE)

January 16, 2025 updated by: Sara Abd El Dayem Mohamed Abed, Aswan University Hospital

Diaphragmatic Dynamics in Laparoscopic Cholecystectomy: Comparing Neuromuscular Blocker Reversal Strategies-A Randomized Trial

The goal of this Randomized Clinical Trial is to compare the postoperative diaphragmatic excursion between patients receiving half-dose neostigmine (0.04 mg/kg) and those receiving full-dose neostigmine (0.08 mg/kg) for neuromuscular blockade reversal.

The main questions it aims to answer are:

  • Does half-dose neostigmine result in similar postoperative diaphragmatic excursion compared to full-dose neostigmine?
  • Does half-dose neostigmine result in similar diaphragmatic thickening fraction compared to full-dose neostigmine? Researchers will compare patients receiving half-dose neostigmine to those receiving full-dose neostigmine to see if there are differences in postoperative diaphragmatic function, respiratory complications, and recovery.

Participants will:

  • Undergo elective laparoscopic cholecystectomy.
  • Receive either half-dose or full-dose neostigmine for neuromuscular blockade reversal.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Fifty patients from both genders scheduled for elective laparoscopic cholecystectomy were enrolled in this study to compare diaphragmatic assessment parameters.

Enrolled participants were randomly assigned to group A (patient receiving full dose of Neostigmine (0.08 mg/kg) plus Atropine (20 mic/kg)) or group B (patient receiving half dose of Neostigmine (0.04 mg/kg) plus Atropine (20 mic/kg)).

This is a prospective study that will be conducted at Aswan University Hospital.

Eligible participants will be adult patients (age ≥ 18 years) scheduled for elective laparoscopic cholecystectomy, with American Society of Anesthesiologists (ASA) physical status I or II, and a body mass index (BMI) < 35 kg/m². Patients with pre-existing diaphragmatic or respiratory disorders, ASA physical status III or IV, BMI > 35 kg/m², chronic opioid use or abuse, pregnancy, or breastfeeding will be excluded.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 1

Contacts and Locations

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

Study Contact

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults scheduled for elective laparoscopic cholecystectomy.
  • Age: < or = 18 years.
  • Both genders.
  • American Society Of Anesthiologists (ASA) I/II patients.
  • BMI <35

Exclusion Criteria:

  • Pre-existing diaphragmatic or respiratory disorders.
  • ASA III/IV
  • BMI >35
  • Chronic opioid use or abuse
  • Pregnancy or breastfeeding

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: full dose of Neostigmine
Drug: full dose of Neostigmine

• Group A: received 10ml (a full dose of Neostigmine (0.08 mg/kg) plus Atropine (20 mic/kg+7ml normal saline)

Measured using ultrasound Time frame: preoperatively and at zero, 10 minutes and 30 minutes postoperatively.
Active Comparator: half dose of Neostigmine
Drug: half dose of Neostigmine

• Group B: received 10ml (a half dose of Neostigmine (0.04 mg/kg) plus Atropine (20 mic/kg+8ml normal saline).

Measured using ultrasound Time frame: preoperatively and at zero, 10 minutes and 30 minutes postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragmatic Dynamics
Time Frame: preoperatively and at zero, 10 minutes and 30 minutes postoperatively
To compare the postoperative diaphragmatic excursion between patients receiving half-dose neostigmine (0.04 mg/kg) and those receiving full-dose neostigmine (0.08 mg/kg) for neuromuscular blockade reversal.
preoperatively and at zero, 10 minutes and 30 minutes postoperatively

Collaborators and Investigators

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

Sponsor

Aswan University Hospital

Investigators

  • Study Chair: Ayman M El-demirdash, Anesthesia, surgical intensive care and pain management - Aswan University Hospital
  • Study Director: Hani M Raslan, Anesthesia, surgical intensive care and pain management - Aswan University Hospital
  • Study Director: Zaher Z Zaher, Anesthesia, surgical intensive care and pain management - Aswan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

January 25, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 944/7/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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