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

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Neuromuscular Block, Residual

Treatments

Drug: Sugammadex
Drug: Neostigmine

Study type

Interventional

Funder types

Other

Identifiers

NCT05724550
H2212-027-1383

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

2 to 7 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

73 participants in 2 patient groups

Neostigmine
Active Comparator group
Description:
The use of neostigmine 0.02mg/kg for reversal of neuromuscular blocking agent.
Treatment:
Drug: Neostigmine
Sugammadex
Experimental group
Description:
The use of sugammadex 2mg/kg for reversal of neuromuscular blocking agent.
Treatment:
Drug: Sugammadex

Trial contacts and locations

1

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Central trial contact

Jung-Bin Park, M.D.

Data sourced from clinicaltrials.gov

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