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

Diaphragm and Lung Ultrasound After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children Undergoing Surgery : A Randomized Double-blind Controlled Trial

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 Overview

• Status: Recruiting
• Conditions: Neuromuscular Block, Residual
• Intervention / Treatment: Drug: Neostigmine; Drug: Sugammadex

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung-Bin Park, M.D.; Phone Number: 82 220723664; Email: jb4001@snu.ac.kr

Study Locations

• Korea, Republic of
  • Jongrogu
    • Seoul, Jongrogu, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: Jung-Bin Park, M.D.; Phone Number: 82 220723664; Email: jb4001@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neostigmine; The use of neostigmine 0.02mg/kg for reversal of neuromuscular blocking agent.	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.; Other Names: Neostigmine methylsulfate
Experimental: Sugammadex; The use of sugammadex 2mg/kg for reversal of neuromuscular blocking agent.	Drug: 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.; Other Names: bridion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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	From injection of neuromuscular block reversal agent to extubation, not to exceed 20 minutes
perioperative respiratory adverse events	laryngospasm, bronchospasm, desaturation (SpO2 < 95%), airway obstruction, severe coughing, postoperative stridor during the emergence period	intraoperative
length of stay in post-anesthesia care unit	Length of stay in post-anesthesia care unit	from entering the post-anesthesia care unit to discharge from the post-anesthesia care unit, up to 24 hours
Adverse events occurred during post-anesthesia care unit stay	agitation, stridor, desaturation (SpO2<95%), nausea, vomiting, bradycardia, somnolence, need for oxygen support	from entering the post-anesthesia care unit to discharge from the post-anesthesia care unit, up to 24 hours
postoperative pulmonary complication	pneumonia, respiratory failure, pleural effusion, atelectasis described in postoperative chest radiography, pneumothorax, bronchospasm, aspiration pneumonia	from entering the general ward after surgery to discharge from hospital, up to 7 days

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Anticipated): February 15, 2025
• Study Completion (Anticipated): April 15, 2025

Study Registration Dates

• First Submitted: January 15, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: H2212-027-1383

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No