Using Diaphragm Ultrasonography, Sugammadex Recovers Diaphragmatic Function More Effectively Than Neostigmine.

Ain Shams University

Status and phase: Completed; Phase 1

Conditions: Perioperative Diaphragmatic Function

Treatments: Drug: Neostigmine; Drug: sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT06982092

FMASU MS535/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

sugammadex

Active Comparator group

Description:

Group A: receive sugammadex (SUG group) as the reversal drug

Treatment:

Drug: sugammadex

neostigmine

Active Comparator group

Description:

receive neostigmine (NEO group) as reversal drug.

Treatment:

Drug: Neostigmine