Role of Sugammadex and Neostigmine for Recovery From Rocuronium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group S

patients who will receive sugammadex for recovery from rocuronium and its effect will be assessed by ultrasound and nerve stimulation.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Group N

patients who will receive neostigmine for recovery from rocuronium and its effect will be assessed by ultrasound and nerve stimulation.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No