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

NCT05724550 | Completed DMC

• 1 other identifier: H2212-027-1383
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Block, Residual

Outcome Measures

Primary Outcomes (1)

• 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)

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

Secondary Outcomes (8)

• modified lung ultrasound score before neuromuscular blockade (LUS_T0)

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

• modified lung ultrasound score after reversing neuromuscular blockade (LUS_T1)

  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)

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

• total recovery time (sec)

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

• perioperative respiratory adverse events

  intraoperative

Study Arms (2)

Neostigmine

ACTIVE COMPARATOR

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

Drug: Neostigmine

Sugammadex

EXPERIMENTAL

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

Drug: Sugammadex

Interventions

Sugammadex 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.

Also known as: bridion

Sugammadex

Neostigmine 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.

Also known as: Neostigmine methylsulfate

Neostigmine

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongrogu, 03080, South Korea

Location

Related Publications (1)

• Park JB, Kim TW, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS, Lee JH. Ultrasonographic assessment of sugammadex-enhanced early recovery of diaphragmatic function in children: A randomised double-blind controlled trial. Eur J Anaesthesiol. 2025 Oct 1;42(10):907-915. doi: 10.1097/EJA.0000000000002231. Epub 2025 Jul 7.

  PMID: 40625141 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: February 13, 2023
• Study Start: February 22, 2023
• Primary Completion: June 7, 2024
• Study Completion: June 8, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

KR (1)