Skip to content

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

Study of Effects of Neostigmine Versus Sugammadex in Ultrasonographic Evaluation of Recovery of Diaphragmatic Function After General Anesthesia

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06982092
Enrollment
60
Registered
2025-05-21
Start date
2024-08-26
Completion date
2025-01-15
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Diaphragmatic Function

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.

Interventions

DRUGsugammadex

: 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.

DRUGNeostigmine

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Masking description

double (Participant, Care Provider)

Intervention model description

Interventional, parallel

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
the difference between diaphragmatic thickening fraction at 30 minuets vs. The corresponding baseline valuesBy using diaphragmatic ultrasonography baseline diaphragmatic thickening fraction preoperative and at Zero time, 10 minutes, and 30 minutes in Post anesthesia care unitPrior to induction of anesthesia, baseline thickening fractioning evaluated using diaphragmatic ultrasonography, All patients were given general anesthesia, after pre-oxygenation induction of anesthesia was started using fentanyl and propofol. Intubation was done with proper size endotracheal tube after relaxation provided by rocuronium, At the end the operation patients received the reversal drug according to the group to which they had been randomised. Immediately prior to extubation, diaphragm ultrasonography was carried out to assess muscle recovery in each patient during spontaneous breathing. Two additional diaphragm ultrasound sessions were carried out 10 minutes and 30 minutes after discharge from the operating theatre, while the patients are in the post anesthesia care unit.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026