Skip to main content
OpenTrials
Completed

NCT Number: NCT05354466

Perioperative Respiratory Adverse events_sugammadex

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Complication

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul national university hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex injection

Drug

sugammadex as reversal agent

Neostigmine

Drug

neostigmine as a reversal agent

Primary outcomes

  1. 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

Secondary outcomes

  1. bradycardia

    Time frame: from induction of anesthesia to end of operation, about 3 hours

    administration of IV atropine, glycopyrrolate, epinephrine, ephedrine

  2. Cardiac arrest

    Time frame: from induction of anesthesia to end of operation, about 3 hours

    documented chest compressions/defibrillation/cardioversion

  3. 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

  4. Allergic reaction

    Time frame: from induction of anesthesia to end of operation, about 3 hours

    redness, urticaria, wheeze

  5. Bronchospasm

    Time frame: from induction of anesthesia to end of operation, about 3 hours

    administration of albuterol, epinephrine

  6. Nausea and vomiting

    Time frame: from induction of anesthesia to end of operation, about 3 hours

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2022
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.