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Clinical Trials/NCT05354466
NCT05354466UnknownNot Applicable

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 enrollmentStarted: June 27, 2022Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
174
Locations
1
Primary Endpoint
Perioperative respiratory adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Experimental

Intervention: Sugammadex injection (Drug)

Neostigmine as reversal agent

Active Comparator

Intervention: Neostigmine (Drug)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eun-hee Kim

Clinical associate professor

Seoul National University Hospital

Study Sites (1)

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