Perioperative Respiratory Adverse events_sugammadex

July 10, 2022 updated by: Eun-hee Kim, Seoul National University Hospital

Effect of Sugammadex Versus Neostigmine on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: a Randomized Controlled Trial

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Eun-hee Kim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sugammadex as reversal agent
Drug: Sugammadex injection
sugammadex as reversal agent
Active Comparator: Neostigmine as reversal agent
Drug: Neostigmine
neostigmine as a reversal agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from induction of anesthesia to end of operation, about 3 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 10, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2203-061-1305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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