Diaphragm Function After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children

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

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-22

Study Completion Date

2024-06-08

Brief Summary

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This study is to evaluate the recovery of diaphragm function and atelectasis after reversal of neuromuscular blockade with Neostigmine and Sugammadex using lung ultrasound and diaphragm ultrasound for children aged 2 to 7 who are scheduled for the surgical procedure under general anesthesia.

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Detailed Description

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Conditions

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Neuromuscular Block, Residual

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Neostigmine

The use of neostigmine 0.02mg/kg for reversal of neuromuscular blocking agent.

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

* Neostigmine methylsulfate(0.5mg/mL) 0.02mg/kg
* After confirming Train-of-four counts 4, patients allocated to neostigmine group receive neostigmine 0.02mg/kg (maximum 5mg) combined with atropine 0.02mg/kg for reversal of rocuronium at the end of the surgery.

Sugammadex

The use of sugammadex 2mg/kg for reversal of neuromuscular blocking agent.

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

* Sugammadex(100mg/mL), 2mg/kg
* After confirming Train-of-four counts 4, patients allocated to sugammadex group receive sugammadex 2mg/kg for reversal of rocuronium at the end of the surgery.

Interventions

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Sugammadex

* Sugammadex(100mg/mL), 2mg/kg
* After confirming Train-of-four counts 4, patients allocated to sugammadex group receive sugammadex 2mg/kg for reversal of rocuronium at the end of the surgery.

Intervention Type DRUG

Neostigmine

* Neostigmine methylsulfate(0.5mg/mL) 0.02mg/kg
* After confirming Train-of-four counts 4, patients allocated to neostigmine group receive neostigmine 0.02mg/kg (maximum 5mg) combined with atropine 0.02mg/kg for reversal of rocuronium at the end of the surgery.

Intervention Type DRUG

Other Intervention Names

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bridion Neostigmine methylsulfate

Eligibility Criteria

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Inclusion Criteria

* Patients between the ages of 2 and 7 who are scheduled for surgery lasting more than 1 hour under general anesthesia using a neuromuscular blocking agent

Exclusion Criteria

* Patients with a history of severe respiratory disease with a high risk of bronchoconstriction
* Patients with abnormal findings on preoperative chest radiography such as severe atelectasis, pneumothorax, pleural effusion, or pneumonia.
* Patients with severe renal or liver disease, or neuromuscular disease
* Patients with a history of allergy to drugs (sugammadex, rocuronium neostigmine)
* Patients with significant bradycardia
* Patients scheduled for surgery where estimated blood loss during surgery is expected to be more than 30% of estimated blood volume, or cases where fluid imbalance is expected to be severe during surgery
* patients scheduled for lung parenchyme/diaphragm/thoracic surgery
* other researchers considered it inappropriate to participate in research.

Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes