Clinical trial NCT06787638: Effects of Neostigmine-dose on Diaphragmatic Dynamics
Official title: Diaphragmatic Dynamics in Laparoscopic Cholecystectomy: Comparing Neuromuscular Blocker Reversal Strategies-A Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Diaphragm Ultrasound
Keywords: Diaphragmatic Thickening Fraction
Diaphragmatic Excursion
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diaphragmatic Dynamics
timeFrame: preoperatively and at zero, 10 minutes and 30 minutes postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Anesthesia, surgical intensive care and pain management - Aswan University Hospital
name: Ayman M El-demirdash
role: STUDY_CHAIR
affiliation: Anesthesia, surgical intensive care and pain management - Aswan University Hospital
name: Hani M Raslan
role: STUDY_DIRECTOR
affiliation: Anesthesia, surgical intensive care and pain management - Aswan University Hospital
name: Zaher Z Zaher
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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/