Perioperative Respiratory Adverse events_sugammadex

Not Applicable

• Conditions: Respiratory Complication
• Interventions: Drug: Neostigmine; Drug: Sugammadex injection

• Registration Number: NCT05354466
• Lead Sponsor: Seoul National University Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-29
• Study Start: 2022-06-27
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-10
• Last Update Posted: 2022-07-12
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neostigmine as reversal agent	Neostigmine	-
Sugammadex as reversal agent	Sugammadex injection	-

Primary Outcome Measures

Name	Time	Method
Perioperative respiratory adverse events	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 Outcome Measures

Name	Time	Method
Cardiac arrest	from induction of anesthesia to end of operation, about 3 hours	documented chest compressions/defibrillation/cardioversion
Anaphylaxis	from induction of anesthesia to end of operation, about 3 hours	administration of epinephrine, methylprednisolone, diphenhydramine, documented diagnosis of anaphylactic/ anaphylatoid reaction
Nausea and vomiting	from induction of anesthesia to end of operation, about 3 hours
bradycardia	from induction of anesthesia to end of operation, about 3 hours	administration of IV atropine, glycopyrrolate, epinephrine, ephedrine
Bronchospasm	from induction of anesthesia to end of operation, about 3 hours	administration of albuterol, epinephrine
Allergic reaction	from induction of anesthesia to end of operation, about 3 hours	redness, urticaria, wheeze

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of