Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
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