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

Neuromuscular Block, Residual Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724550
• Other study ID #: H2212-027-1383
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: April 15, 2025

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: Jung-Bin Park, M.D.
• Phone: 220723664
• Email: jb4001[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: April 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Neuromuscular Block, Residual

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongrogu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	perioperative respiratory adverse events	laryngospasm, bronchospasm, desaturation (SpO2 < 95%), airway obstruction, severe coughing, postoperative stridor during the emergence period	intraoperative
Secondary	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
Secondary	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
Secondary	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