Actively Recruiting

Phase Not Applicable
Age: 1Year - 6Years
All Genders
ID07450495

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

Led by Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong · Updated on 2026-03-04

80

Participants Needed

1

Research Sites

5 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the effectiveness and safety of two concentrations of sevoflurane inhalation (6% and 8%) for anesthesia induction in children aged 1 to 6 years undergoing minor ophthalmic surgery, such as chalazion excision. The study is a randomized controlled trial focusing on pediatric patients with a physical status classified as ASA I and suitable for inhalation anesthesia. Participants will be randomly assigned to receive either 6% or 8% sevoflurane inhalation through a face mask for anesthesia induction. Both groups will undergo general anesthesia maintained with sevoflurane during the minor eye surgery. The study measures include the Pediatric Anesthesia Emergence Delirium (PAED) scale, along with other parameters such as induction and recovery times, hemodynamic monitoring, and perioperative respiratory events. Throughout the trial, participants will be closely monitored for emergence agitation within 30 minutes after recovery, as well as for adverse events such as respiratory depression, hypoxia, coughing, nausea, and vomiting. Researchers will also record induction and recovery times immediately following anesthesia administration and discontinuation. Study participation involves careful evaluation and monitoring to assess the safety and effects of the two sevoflurane concentrations during the surgical procedure and recovery period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Year - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Short duration during surgery

Participants receive sevoflurane inhalation anesthesia at either 6% or 8% concentration for induction during minor ophthalmic surgery.

1 visit (in-person) for anesthesia induction and surgery

Trial Site Locations

Total: 1 location

1

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

Shantou, Guangdong, China, 515041

Actively Recruiting

Loading map...

Research Team

L

Laiwen Lv, MSc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here