Perioperative Respiratory Adverse events

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-27

Study Completion Date

2024-09-04

Brief Summary

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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

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Detailed Description

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Conditions

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Respiratory Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sugammadex as reversal agent

Group Type EXPERIMENTAL

Sugammadex injection

Intervention Type DRUG

sugammadex as reversal agent

Neostigmine as reversal agent

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

neostigmine as a reversal agent

Interventions

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Sugammadex injection

sugammadex as reversal agent

Intervention Type DRUG

Neostigmine

neostigmine as a reversal agent

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No