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

NCT ID: NCT06982092

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-26
• Study Completion Date: 2025-01-15

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.

Conditions

Perioperative Diaphragmatic Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

sugammadex

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

Group Type: ACTIVE_COMPARATOR

sugammadex

Intervention Type: DRUG

: patients will receive the reversal drug according to the group to which they had been randomised. in the Sugammadex Group will receive 2 mg/kg sugammadex.

neostigmine

receive neostigmine (NEO group) as reversal drug.

Group Type: ACTIVE_COMPARATOR

Neostigmine

Intervention Type: DRUG

Patients in the NEO Group will receive 50 mic/kg neostigmine and .01-.02 mg/kg atropine

Interventions

sugammadex

: patients will receive the reversal drug according to the group to which they had been randomised. in the Sugammadex Group will receive 2 mg/kg sugammadex.

Intervention Type: DRUG

Neostigmine

Patients in the NEO Group will receive 50 mic/kg neostigmine and .01-.02 mg/kg atropine

Intervention Type: DRUG

Other Intervention Names

bridion

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mostafa Hamed Mahmoud, M.B.B.CH

Role: PRINCIPAL_INVESTIGATOR

Anesthesia resident Ain Shams University

Locations

faculty of medicine, ain shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MS535/2024

Identifier Type: -

Identifier Source: org_study_id