Effect of Sugammadex Versus Neostigmine on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: a Randomized Controlled Trial

Seoul National University Hospital1 site in 1 country174 target enrollmentJune 27, 2022

ConditionsRespiratory Complication

InterventionsSugammadex injection Neostigmine

DrugsSugammadex injection Neostigmine

Overview

Phase: Not Applicable
Intervention: Sugammadex injection
Conditions: Respiratory Complication
Sponsor: Seoul National University Hospital
Enrollment: 174
Locations: 1
Primary Endpoint: Perioperative respiratory adverse events
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Perioperative respiratory adverse events are common in children. We aimed to evaluate the effect of sugammadex on the incidence of perioperative respiratory adverse events in pediatric patients receiving tonsillectomy

Registry

clinicaltrials.gov

Start Date

June 27, 2022

End Date

December 31, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Eun-hee Kim

Clinical associate professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

•Pediatric patients aged 2-6 years who were scheduled for tonsillectomy under general anesthesia were enrolled

Exclusion Criteria

•a recent history of upper respiratory tract infection within 2 weeks of surgery
•allergic reaction to sugammadex
•renal failure
•liver failure
•arrhythmia

Arms & Interventions

Sugammadex as reversal agent

Intervention: Sugammadex injection

Neostigmine as reversal agent

Intervention: Neostigmine

Outcomes

Primary Outcomes

Perioperative respiratory adverse events

Time Frame: from induction of anesthesia to end of operation, about 3 hours

the incidence of overall perioperative respiratory adverse events; oxygen desaturation \< 95%, airway obstruction, laryngospasm, bronchospasm, severe coughing, or postoperative stridor

Secondary Outcomes

Nausea and vomiting(from induction of anesthesia to end of operation, about 3 hours)
Anaphylaxis(from induction of anesthesia to end of operation, about 3 hours)
bradycardia(from induction of anesthesia to end of operation, about 3 hours)
Cardiac arrest(from induction of anesthesia to end of operation, about 3 hours)
Bronchospasm(from induction of anesthesia to end of operation, about 3 hours)
Allergic reaction(from induction of anesthesia to end of operation, about 3 hours)