RecruitingNot Applicable

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

China80 participantsStarted 2025-02-25

Plain-language summary

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.

Who can participate

Age range1 Year – 6 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

PAED score

Timeframe: Within 30 minutes after recovery

Trial details

NCT IDNCT07450495

SponsorJoint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-25

Contact for this trial

Laiwen Lv, MSc.

13750440405 llw@jsiec.org

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