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Use of fNIRS to compare Emergence Delirium in children undergoing Sevoflurane Vs Propofol anaesthesia

Comparative assessment of cortical hemodynamic activity using functional Near Infrared Spectroscopy (fNIRS) and correlation with Emergence Delirium in children undergoing anaesthesia with Sevoflurane Vs Propofol TIVA - A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041573
Enrollment
70
Registered
2022-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Sevoflurane: Patient will be induced using 8% Sevoflurane in 50% Nitrous Oxide and oxygen at 3L/min at induction till attaining a MAC of 1.8 to 2 and maintained using Sevoflurane 2-3 %

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age between 3 -I0 years 2.Patients undergoing pediatric procedures under GA 3.ASA grade I and II 4.Consent from parents 5.Can be either males or females

Exclusion criteria

Exclusion criteria: 1.Refusal to consent 2.History of perinatal hypoxia/ preterm delivery 3.History of seizure disorders 4.History of developmental disorder 5.History of any psychiatric illness 6.Any electrolyte imbalance

Design outcomes

Primary

MeasureTime frame
Correlate the changes in fNIRS recordings with sevoflurane and propofol in the frontal cortex of children of 3 ? 10 years undergoing pediatric proceduresTimepoint: 1. Baseline fNIRS reading before induction 2.fNIRS reading for 5 minutes after securing the airway with LMA/ETT 3.fNIRS reading for 5 minutes at the end of the procedure after stopping the anaesthetic agent

Secondary

MeasureTime frame
Incidence of emergence delirium in sevoflurane versus propofol total intravenous anaesthesia as assessed by the PAED scale, evaluating postoperative pain using CHEOPS , and postoperative delirium assessment using CORNELL scoreTimepoint: PAED Score is recorded during 5 min intervals till 30 minutes from the time of awakening. Postoperative pain is assessed using CHEOP score , measured every I0 min intervals till 30min from awakening Patient is assessed for postoperative delirium using CAPD at the end of 2 hours.

Countries

India

Contacts

Public ContactDr Kavya V Nair

All India Institute of Medical Sciences , New Delhi

k.punit@yahoo.com9873106516

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026