6% versus 8% sevoflurane for inducing anesthesia in children having minor eye surgery
Effectiveness and Safety of 6% Versus 8% Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Minor Surgery: A Randomized Controlled Trial
We will test whether giving 6% or 8% sevoflurane to put children aged 1–6 to sleep for minor ophthalmic surgery leads to less agitation when they wake up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 1 Year to 6 Years |
| Sex | All |
| Sponsor | Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shantou, Guangdong) |
| Trial ID | NCT07450495 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will assign children aged 12–72 months undergoing minor ophthalmic procedures to inhalation induction with either 6% or 8% sevoflurane. The main outcome is emergence agitation measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale, with secondary outcomes including hemodynamic measures, induction and recovery times, and adverse events. Only ASA physical status I children judged suitable for inhalation anesthesia and with parental consent are eligible, and several medical exclusions (eg, recent URI, asthma, malignant hyperthermia risk) apply. The procedures and monitoring will take place at the Joint Shantou International Eye Center in Shantou, Guangdong.
Who should consider this trial
Good fit: Children aged 1–6 years (12–72 months) with ASA physical status I scheduled for minor ophthalmic surgery (for example, chalazion excision) whose parents provide written informed consent are ideal candidates.
Not a fit: Children with ASA II or higher, known respiratory or cardiac disease, recent upper respiratory infection, history of malignant hyperthermia, sevoflurane allergy, anticipated difficult airway, or whose parents decline participation are not eligible and unlikely to benefit.
Why it matters
Potential benefit: If successful, the preferred sevoflurane concentration may reduce emergence agitation and improve the comfort and speed of recovery after pediatric eye procedures.
How similar studies have performed: Previous research has shown sevoflurane is associated with emergence agitation in young children and various mitigation strategies have had mixed results, so direct head-to-head comparisons of induction concentrations like 6% versus 8% remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shantou, Guangdong
- Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong — Shantou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Laiwen Lv, MSc.
- Email: llw@jsiec.org
- Phone: 13750440405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.