A clinical trial to find out the minimum concentration of sevoflurane for intra- ocular pressure measurement in children with glaucoma

EC 50 of sevoflurane for intra- ocular pressure measurement in anaesthetized children with glaucoma: a prospective observational study

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/04/032551

Enrollment

Registered

2021-04-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H408- Other glaucoma

Interventions

None listed

Eligibility

Inclusion criteria

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

Exclusion criteria: Patients with cardiac co-morbidities, known airway difficulties, contra indications to the anaesthetic drugs (e.g., malignant hyperthermia), neonates ( < 1 month)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

India

Contacts

Public ContactNitika Goel

PGIMER, Chandigarh

nitikagoel7@gmail.com8826622159

Outcome results