Perioperative Respiratory Adverse events_sugammadex
Effect of Sugammadex Versus Neostigmine on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: a Randomized Controlled Trial
1 other identifier
interventional
174
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2022
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2022
CompletedFirst Posted
Study publicly available on registry
April 29, 2022
CompletedStudy Start
First participant enrolled
June 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2024
CompletedSeptember 20, 2024
September 1, 2024
2.2 years
April 26, 2022
September 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Perioperative respiratory adverse events
the incidence of overall perioperative respiratory adverse events; oxygen desaturation \< 95%, airway obstruction, laryngospasm, bronchospasm, severe coughing, or postoperative stridor
from induction of anesthesia to end of operation, about 3 hours
Secondary Outcomes (6)
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
Anaphylaxis
from induction of anesthesia to end of operation, about 3 hours
Allergic reaction
from induction of anesthesia to end of operation, about 3 hours
Bronchospasm
from induction of anesthesia to end of operation, about 3 hours
- +1 more secondary outcomes
Study Arms (2)
Sugammadex as reversal agent
EXPERIMENTALNeostigmine as reversal agent
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Pediatric patients aged 2-6 years who were scheduled for tonsillectomy under general anesthesia were enrolled
You may not qualify if:
- a recent history of upper respiratory tract infection within 2 weeks of surgery
- allergic reaction to sugammadex
- renal failure
- liver failure
- arrhythmia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul national university hospital
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical associate professor
Study Record Dates
First Submitted
April 26, 2022
First Posted
April 29, 2022
Study Start
June 27, 2022
Primary Completion
September 4, 2024
Study Completion
September 4, 2024
Last Updated
September 20, 2024
Record last verified: 2024-09