Role of Sugammadex and Neostigmine for Recovery From Rocuronium

Anesthesia Clinical Trial

Official title:

Sugammadex Versus Neostigmine for Recovery of Respiratory Muscle Strength Measured by Ultrasonography in the Postextubation Period in Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06432621
• Other study ID #: MD201/2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

evaluation the reversal of neuromuscular blocking by sugammadex versus neostigmine through assessing the residual neuromuscular blocking effect by ultrasound imaging of expiratory muscle strength and diaphragmatic excursion.

Description:

All patients will be assessed preoperatively by careful history taking (history of allergy to rocuronium, neostigmine, or sugammadex), full medical history taking , ASA classification and surgical history Premedication with 2mg midazolam. Anesthesia will be induced with propofol 1-2 mg /kg and fentanyl 1-2 mic/kg. After calibration of TOF (train of four) rocuronium 0.6 mg/kg will be administered, and tracheal intubation will be performed in the absence of train-of four (TOF) count. Rocuronium 0.15mg/kg and Sevoflurane will be used for maintenance of anesthesia.

At the end of the surgery, patients in group A will receive sugammadex (2 mg/kg) and patients in group B will receive neostigmine (50 μg/kg, maximum 5 mg) combined with atropine (25 μg/kg, maximum 2.5 mg) after TOF counts at least exceeding 1 and extubation will be performed in the operating room when the patient is fully awake and fulfilled clinical criteria for extubation.

Diaphragm excursion (DE), reflecting the expiratory and inspiratory muscle strength, respectively, will be measured via ultrasonography.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients with American Society of Anesthesiology (ASA) physical status classification I and II

Exclusion Criteria:

• 1. American Society of Anesthesiology (ASA) physical status classification III-V 2. renal impairment 3. Significant liver disease (Child-Pugh B or C class) 4. History of chronic obstructive pulmonary disease 5. Known or suspected neuromuscular disease. 6. Cardiac arrhythmia or use of antiarrhythmic drugs.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation
patients will be randomly divided into two groups using a computer generated random number chart. Group S will receive sugammadex for reversal of rocuronium, whereas Group N will receive neostigmine for reversal of rocuronium using nerve stimulation and ultrasound to asses recovery of respiratory muscle

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of sugammadex and neostigmine on reversal of rocuronium	complete recovery of skeletal muscle assesed by train of four and diaghragmatic excursion by ultrasuond automatically recorded utilizing the TOF monitoring TFIO and diaphragm excursion (DE), reflecting the expiratory and inspiratory muscle strength, respectively, will be measured via ultrasonography (Sonosite M-Turbo) at 3 predefined time points: before induction (baseline levels), TOFR =0.9 (postextubation), and after 30 minutes in the PACU.	4 hours