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Effects of Neostigmine-dose on Diaphragmatic Dynamics

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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06787638
Acronym
DTF/DE/AChE
Enrollment
50
Registered
2025-01-22
Start date
2025-01-25
Completion date
2026-04-30
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm Ultrasound

Keywords

Diaphragmatic Thickening Fraction, Diaphragmatic Excursion

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.

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.

Interventions

DRUGhalf 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.

DRUGfull 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.

Sponsors

Aswan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Diaphragmatic Dynamicspreoperatively and at zero, 10 minutes and 30 minutes postoperativelyTo 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.

Contacts

Primary ContactSara A Mohamed
sara1704387@med.aswu.edu.eg+201153006436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026