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

Seoul National University Hospital73 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Neuromuscular Block, Residual

Interventions

SugammadexDRUG

* 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.

NeostigmineDRUG

* 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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Hospital

Seoul, Jongrogu, South Korea

Outcomes

Primary Outcomes

Diaphragm excursion ratio

The ratio of diaphragm excursion at the time before injecting neuromuscular blocking agent before surgery (T0) and diaphragm excursion at the time after reversal of neuromuscular blocking agent (T1)

Time frame: during diaphragm ultrasound procedure after reversal of neuromuscular blocking agent (T1), an average of 10 minute

Secondary Outcomes

modified lung ultrasound score before neuromuscular blockade (LUS_T0)

Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss)

Time frame: during lung ultrasound procedure before neuromuscular blocking agent (T0), an average of 10 minutes

modified lung ultrasound score after reversing neuromuscular blockade (LUS_T1)

Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss)

Time frame: during lung ultrasound procedure after reversing neuromuscular blocking agent(T1), an average of 10 minutes

modified lung ultrasound score at post-anesthesia care unit (PACU) (LUS_T2)

Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss)

Time frame: 30 minutes after entering the post-anesthesia care unit (T2)

total recovery time (sec)

time from injection of a neuromuscular block reversal agent to extubation

Time frame: From injection of neuromuscular block reversal agent to extubation, not to exceed 20 minutes

Data from ClinicalTrials.gov

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