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Recruiting NCT07450495

Effect of Different Concentrations of Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Surgery

No phase Interventional Chalazion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sevoflurane.
Who it may be relevant to
Registry conditions: Chalazion. Basic parameters: 1 year — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness and Safety of 6% Versus 8% Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Minor Surgery: A Randomized Controlled Trial

Overview

This randomized controlled trial aims to compare the effectiveness and safety of 6% versus 8% sevoflurane inhalation induction in pediatric patients undergoing minor ophthalmic surgery. The primary outcome is emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes include hemodynamic parameters, induction time, recovery time, and adverse events.

Interventions

  • Drug Sevoflurane
    Sevoflurane inhalation anesthesia was used for induction and maintenance of general anesthesia in pediatric patients undergoing minor ophthalmic surgery.

Primary outcome measures

  • PAED score [Time frame: Within 30 minutes after recovery]
Secondary outcome measures (7)
  • Induction time [Time frame: Immediately after anesthesia induction]
  • Recovery time [Time frame: Immediately after anesthesia discontinuation]
  • Minimum alveolar concentration (MAC) [Time frame: Perioperatively]
  • Respiratory depression [Time frame: Perioperatively]
  • Hypoxia [Time frame: Perioperatively]
  • Cough [Time frame: Perioperatively]
  • Nausea and vomiting [Time frame: Immediately after anesthesia until discharge]

Eligibility criteria

Inclusion criteria

  • Children aged 1 to 6 years (12-72 months)
  • Scheduled to undergo minor ophthalmic surgery (e.g., chalazion excision) under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I
  • Assessed as suitable for inhalation anesthesia by anesthesiologists
  • Written informed consent obtained from parents or legal guardians

Exclusion criteria

  • ASA physical status II or higher
  • Known hepatic or renal dysfunction
  • Congenital heart disease
  • History of malignant hyperthermia
  • Known allergy to sevoflurane
  • History of asthma or severe respiratory disease
  • Upper respiratory tract infection within the past 4 weeks
  • Anticipated difficult airway
  • Refusal of participation by parents or legal guardians

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Joint Shantou International Eye Center of Shantou University and The Chinese University of — Shantou

Identifiers

NCT: NCT07450495 · EC20240514(3)-P38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗