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Perioperative Respiratory Adverse events_sugammadex

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Seoul National University

Status and phase

Completed
Phase 4

Conditions

Respiratory Complication

Treatments

Drug: Neostigmine
Drug: Sugammadex injection

Study type

Interventional

Funder types

Other

Identifiers

NCT05354466
2203-061-1305

Details and patient eligibility

About

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

Enrollment

174 patients

Sex

All

Ages

2 to 6 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

174 participants in 2 patient groups

Sugammadex as reversal agent
Experimental group
Treatment:
Drug: Sugammadex injection
Neostigmine as reversal agent
Active Comparator group
Treatment:
Drug: Neostigmine

Trial contacts and locations

1

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Central trial contact

Eun-hee Kim

Data sourced from clinicaltrials.gov

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