Clinical trial NCT06982092: Using Diaphragm Ultrasonography, Sugammadex Recovers Diaphragmatic Function More Effectively Than Neostigmine.
Official title: Study of Effects of Neostigmine Versus Sugammadex in Ultrasonographic Evaluation of Recovery of Diaphragmatic Function After General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Perioperative Diaphragmatic Function
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, parallel
Primary purpose: OTHER

Brief summary: The aim of our study is to assess differences in the recovery of muscle function, using diaphragm ultrasonography, after reversal of a rocuronium-induced block, using neostigmine versus sugammadex

Detailed description: Post-operative residual curarization (PORC) remains an essential clinical challenge. The possibility of assessing muscle function and excluding PORC using noninvasive tools in the perioperative period is very attractive. Therefore, we used diaphragm ultrasonography.

The diaphragm is a major respiratory muscle, accounting for 60-70% of the respiratory workload. Its dysfunction involves post-operative respiratory failure.

Diaphragm ultrasound imaging is a cheap and portable technique that allows assessment of diaphragm thickness, thickening, and excursion at a point in time or over time, in ambulatory patients and in mechanically ventilated patients.

Acetylcholinesterase inhibitors can reverse muscle block, but their short half-life may lead to residual curarization in the ward, especially when intermediate or long-acting NMBAs have been administered. Sugammadex is the first selective reversal drug for steroidal NMBAs; it has been shown to give full and rapid recovery of muscle strength, thus minimizing the occurrence of residual curarization.

This study was designed to assess differences in the recovery of the diaphragmatic function, using diaphragm ultrasonography, after reversal of a rocuronium-induced block, using neostigmine versus sugammadex.

It was conducted to 60 patients of both sexes, scheduled for FESS surgeries who underwent deep neuromuscular block with rocuronium. Cases were aged 18-65 years, ASA physical status ІІ or III.

The patients were randomized by computer software randomization and divided into two equal groups; SUG group (n =30 patients) that received 2 mg/kg sugammadex and NEU group (n =30 patients) that received 50 mic/kg and 0.01-0.02 mg/kg atropine.

The following parameters were assessed and recorded; diaphragmatic thickening fraction, diaphragmatic excursion, number of patient with baseline diaphragmatic functionat 30min, spirometry volume, post extubation heart rate, respiratory rate, saturation, bronchospasm, nausea and vomiting.

Eligibility criteria: Inclusion Criteria:

* Patients with American Society of Anesthesiologists' (ASA) physical status I or II or III
* Adult patients aging (18-65) years of both sexes. who undergoing deep neuromuscular block with rocuronium.
* Patients Scheduled for elective FISS surgery

Exclusion Criteria:

* Patient's refusal of procedure or participation in the study.
* ASA class IV.
* History of hepatic disease (Child Pugh B or C class).
* History of renal disease.
* Allergy or hypersensitivity to sugammadex or neostigmine.
* History of neuromuscular disease.
* Diaphragmatic palsy, pregnancy, nursing.

Primary outcomes:
measure: the difference between diaphragmatic thickening fraction at 30 minuets vs. The corresponding baseline values
timeFrame: By using diaphragmatic ultrasonography baseline diaphragmatic thickening fraction preoperative and at Zero time, 10 minutes, and 30 minutes in Post anesthesia care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine, ain shams University
Study officials:
affiliation: Anesthesia resident Ain Shams University
name: Mostafa Hamed Mahmoud, M.B.B.CH
role: PRINCIPAL_INVESTIGATOR
References: