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

NCT07450495 | Recruiting

• 1 other identifier: EC20240514(3)-P38
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chalazion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Induction time

  Immediately after anesthesia induction

• Recovery time

  Immediately after anesthesia discontinuation

• Minimum alveolar concentration (MAC)

  Perioperatively

• Respiratory depression

  Perioperatively

• Hypoxia

  Perioperatively

Study Arms (2)

Sevoflurane 8% Group

ACTIVE COMPARATOR

Participants received 8% sevoflurane inhalation for anesthesia induction via face mask.

Drug: Sevoflurane

Sevoflurane 6% Group

EXPERIMENTAL

Participants received 6% sevoflurane inhalation for anesthesia induction via face mask.

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

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

Also known as: Sevorane,Sevorane,Ultane

Sevoflurane 6% Group; Sevoflurane 8% Group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong

Shantou, Guangdong, 515041, China

RECRUITING

MeSH Terms

Conditions

Chalazion

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Central Study Contacts

Laiwen Lv, MSc.

CONTACT

13750440405; llw@jsiec.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 4, 2026
• Study Start: February 25, 2025
• Primary Completion: February 25, 2026
• Study Completion: April 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)