Effect of Different Concentrations of Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Surgery (SEVO-PED)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chalazion
• Intervention / Treatment: Drug: Sevoflurane

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laiwen Lv, MSc.; Phone Number: 13750440405; Email: llw@jsiec.org

Study Locations

• China
  • Guangdong
    • Shantou, Guangdong, China, 515041
      • Recruiting
      • Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
      • Contact: Laiwen Lv, MSc.; Phone Number: 13750440405; Email: llw@jsiec.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sevoflurane 8% Group; Participants received 8% sevoflurane inhalation for anesthesia induction via face mask.	Drug: Sevoflurane; Sevoflurane inhalation anesthesia was used for induction and maintenance of general anesthesia in pediatric patients undergoing minor ophthalmic surgery.; Other Names: Sevorane,Sevorane,Ultane
Experimental: Sevoflurane 6% Group; Participants received 6% sevoflurane inhalation for anesthesia induction via face mask.	Drug: Sevoflurane; Sevoflurane inhalation anesthesia was used for induction and maintenance of general anesthesia in pediatric patients undergoing minor ophthalmic surgery.; Other Names: Sevorane,Sevorane,Ultane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAED score	Measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED scale ranges from 0 to 20, with higher scores indicating more severe emergence delirium (worse outcome).	Within 30 minutes after recovery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction time	Time from face mask placement to loss of eyelash reflex, measured in seconds.	Immediately after anesthesia induction
Recovery time	Time from discontinuation of sevoflurane to full recovery of consciousness, measured in minutes.	Immediately after anesthesia discontinuation
Minimum alveolar concentration (MAC)	Minimum alveolar concentration (MAC) values recorded during anesthesia maintenance.	Perioperatively
Respiratory depression	Incidence of respiratory depression recorded during the perioperative period.	Perioperatively
Hypoxia	Incidence of hypoxia recorded during the perioperative period.	Perioperatively
Cough	Incidence of cough recorded during the perioperative period.	Perioperatively
Nausea and vomiting	Incidence of nausea and vomiting recorded during the postoperative recovery period.	Immediately after anesthesia until discharge

Collaborators and Investigators

• Sponsor: Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): February 25, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Eye Diseases; Cysts; Eyelid Diseases; Chalazion; Organic Chemicals; Ethers; Hydrocarbons; Hydrocarbons, Halogenated; Hydrocarbons, Fluorinated; Methyl Ethers; Sevoflurane
• Other Study ID Numbers: EC20240514(3)-P38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No