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

NCT06982092 | Completed Phase 1 DMC

• 1 other identifier: FMASU MS535/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Perioperative Diaphragmatic Function

Outcome Measures

Primary Outcomes (1)

• the difference between diaphragmatic thickening fraction at 30 minuets vs. The corresponding baseline values

  Prior 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.

  By using diaphragmatic ultrasonography baseline diaphragmatic thickening fraction preoperative and at Zero time, 10 minutes, and 30 minutes in Post anesthesia care unit

Study Arms (2)

sugammadex

ACTIVE COMPARATOR

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

Drug: sugammadex

neostigmine

ACTIVE COMPARATOR

receive neostigmine (NEO group) as reversal drug.

Drug: Neostigmine

Interventions

sugammadex 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.

Also known as: bridion

sugammadex

Neostigmine DRUG

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

neostigmine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of medicine, ain shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Sugammadex; Neostigmine

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Mostafa Hamed Mahmoud, M.B.B.CH

  Anesthesia resident Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double (Participant, Care Provider)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, parallel

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: May 21, 2025
• Study Start: August 26, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: before 3/2025
• Access Criteria: free

Locations

EG (1)