NCT06787638

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

January 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

January 25, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

January 16, 2025

Last Update Submit

January 16, 2025

Conditions

Diaphragm Ultrasound

Keywords

Diaphragmatic Thickening FractionDiaphragmatic Excursion

Outcome Measures

Primary Outcomes (1)

  • Diaphragmatic Dynamics

    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

Study Arms (2)

full dose of Neostigmine

ACTIVE COMPARATOR
Drug: full dose of Neostigmine

half dose of Neostigmine

ACTIVE COMPARATOR
Drug: half dose of Neostigmine

Interventions

full dose of NeostigmineDRUG

• 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.

full dose of Neostigmine
half dose of NeostigmineDRUG

• 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.

half dose of Neostigmine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Ayoub J, Cohendy R, Prioux J, Ahmaidi S, Bourgeois JM, Dauzat M, Ramonatxo M, Prefaut C. Diaphragm movement before and after cholecystectomy: a sonographic study. Anesth Analg. 2001 Mar;92(3):755-61. doi: 10.1097/00000539-200103000-00038.

    PMID: 11226114BACKGROUND

  • Alam MJ, Roy S, Iktidar MA, Padma FK, Nipun KI, Chowdhury S, Nath RK, Rashid HO. Diaphragm ultrasound as a better predictor of successful extubation from mechanical ventilation than rapid shallow breathing index. Acute Crit Care. 2022 Feb;37(1):94-100. doi: 10.4266/acc.2021.01354. Epub 2022 Jan 11.

    PMID: 35081706BACKGROUND

  • Adeyinka A, Layer DA. Neuromuscular Blocking Agents. 2024 Jun 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537168/

    PMID: 30725853BACKGROUND

Study Officials

  • Ayman M El-demirdash

    Anesthesia, surgical intensive care and pain management - Aswan University Hospital

    STUDY CHAIR

  • 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

    STUDY DIRECTOR

Central Study Contacts

Sara A Mohamed

CONTACT

+201153006436sara1704387@med.aswu.edu.eg

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of anesthesia, surgical intensive care & pain management

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 22, 2025

Study Start

January 25, 2025

Primary Completion

January 1, 2026

Study Completion

April 1, 2026

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share