A clinical trial to find out the minimum concentration of sevoflurane for intra- ocular pressure measurement in children with glaucoma
Phase 3
- Conditions
- Health Condition 1: H408- Other glaucoma
- Registration Number
- CTRI/2021/04/032551
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children of ASA physical status I /II of either sex, in the age group of 1 month to 3 years, with known or suspected congenital or secondary glaucoma unable to co-operate for awake IOP measurement
Exclusion Criteria
Patients with cardiac co-morbidities, known airway difficulties, contra indications to the anaesthetic drugs (e.g., malignant hyperthermia), neonates ( < 1 month)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measure the effective concentration (EC 50) of sevoflurane causing no movement during IOP measurement in 50% of the study population.Timepoint: After 4 minutes of maintenance of the predetermined end tidal sevoflurane concentration
- Secondary Outcome Measures
Name Time Method Adverse effects like laryngospasm, bradycardia, breath holding, desaturation with SpO2 less than 92%Timepoint: at the time of attempting IOP measurement;Degree of variation in IOP measured at baseline (just after induction) and at predetermined sevoflurane concentrationTimepoint: baseline (just after induction) and at 4 minutes of maintenance of the predetermined sevoflurane concentration;Measure the effective concentration (EC 95) of sevoflurane causing no movement during IOP measurement in 95% of the study populationTimepoint: After 4 minutes of maintenance of the predetermined end tidal sevoflurane concentration