Effectiveness and Safety of 6% Versus 8% Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Minor Surgery: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 6
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
RECRUITING
Shantou
Contact Information
Primary
Laiwen Lv, MSc.
llw@jsiec.org
13750440405
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 80
Treatments
Active_comparator: Sevoflurane 8% Group
Participants received 8% sevoflurane inhalation for anesthesia induction via face mask.
Experimental: Sevoflurane 6% Group
Participants received 6% sevoflurane inhalation for anesthesia induction via face mask.
Sponsors
Leads: Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong