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Not yet recruitingNCT06787638DTF/DE/AChEUpdated Jan 22, 2025

Effects of Neostigmine-dose on Diaphragmatic Dynamics

A Phase 1 interventional study of full dose of Neostigmine and half dose of Neostigmine in Diaphragm Ultrasound, sponsored by Aswan University Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by Aswan University Hospital · Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Diaphragm Ultrasound

Keywords

  • Diaphragmatic Thickening Fraction
  • Diaphragmatic Excursion
03

In context

Lead sponsor

Aswan University Hospital is the lead sponsor of 97 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pre-existing diaphragmatic or respiratory disorders.
  • /IV
  • >35
  • Chronic opioid use or abuse
  • Pregnancy or breastfeeding
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    full dose of Neostigmine

    Drug: full dose of Neostigmine

  • Active comparator
    half dose of Neostigmine

    Drug: half dose of Neostigmine

Interventions

  • 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.

  • 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.

06

What researchers measure

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.

    Time frame: preoperatively and at zero, 10 minutes and 30 minutes postoperatively

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 11226114 ↗
  • 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. PubMed 35081706 ↗
  • 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/ PubMed 30725853 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06787638
Lead sponsor
Aswan University Hospital
Responsible party
Sara Abd El Dayem Mohamed Abed (Resident of anesthesia, surgical intensive care & pain management, Aswan University Hospital) — Principal investigator
First posted
Jan 22, 2025
Start date
Jan 25, 2025 (estimated)
Primary completion
Jan 2026 (estimated)
Completion
Apr 2026 (estimated)
Last update
Jan 22, 2025

Study contacts

Sara A Mohamed
Contact
sara1704387@med.aswu.edu.eg
+201153006436
Ayman M El-demirdash
study chair · Anesthesia, surgical intensive care and pain management - Aswan University Hospital
Hani M Raslan
study director · Anesthesia, surgical intensive care and pain management - Aswan University Hospital
Zaher Z Zaher
study director · Anesthesia, surgical intensive care and pain management - Aswan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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