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Role of Sugammadex and Neostigmine for Recovery From Rocuronium

A

Ain Shams University

Status

Active, not recruiting

Conditions

Anesthesia

Treatments

Procedure: using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06432621
MD201/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

Group S
Experimental group
Description:
patients who will receive sugammadex for recovery from rocuronium and its effect will be assessed by ultrasound and nerve stimulation.
Treatment:
Procedure: using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation
Group N
Experimental group
Description:
patients who will receive neostigmine for recovery from rocuronium and its effect will be assessed by ultrasound and nerve stimulation.
Treatment:
Procedure: using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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