Role of Sugammadex and Neostigmine for Recovery From Rocuronium

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of medicine, Ain Shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group S; patients who will receive sugammadex for recovery from rocuronium and its effect will be assessed by ultrasound and nerve stimulation.	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
Experimental: Group N; patients who will receive neostigmine for recovery from rocuronium and its effect will be assessed by ultrasound and nerve stimulation.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Neuromuscular Agents; Cholinesterase Inhibitors; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Parasympathomimetics; Rocuronium; Neostigmine
• Other Study ID Numbers: MD201/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No