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NCT Number: NCT06787638

Effects of Neostigmine-dose on Diaphragmatic Dynamics

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.

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Key information

Conditions

Diaphragm Ultrasound

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

full dose of Neostigmine

Drug

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.

half dose of Neostigmine

Drug

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara A Mohamed

CONTACT

[email protected]

+201153006436

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

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

Acronym: DTF/DE/AChE

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 22, 2025
Registry last updated: Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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