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A comparative study to assess altered mental status in children after awakening from anaesthesia with two different anaesthetic agents named desflurane and sevoflurane, administered while monitoring anaesthetic depth using a monitor called Bispectral index

Emergence Delirium with Bispectral Index (BIS)-Guided Desflurane vs Sevoflurane inhalational anaesthesia in Paediatric Population - A Randomized Controlled Study - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086967
Enrollment
220
Registered
2025-05-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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: Bispectral index guided inhalational anaesthesia with desflurane: General anaesthesia will be maintained with Desflurane, an inhalational anaesthetic agent. Control Intervention1: Bispe

Sponsors

A Chaitanya Pratyusha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Elective sub-umbilical surgeries under general anaesthesia

Exclusion criteria

Exclusion criteria: Known neurological or psychiatric disorders. History of adverse reactions to anaesthetic agents. Emergency surgery. Duration of surgery more than 3 hours. Anticipated elective mechanical ventilation in the post-operative period. Severe renal or hepatic failure. Coagulation disorders. Cognitive impairment or communication disorders. Allergy to any of the drugs included in the study protocol. Cutaneous infections or anatomical malformation at the puncture site for caudal block

Design outcomes

Primary

MeasureTime frame
To compare the incidence and degree of emergence delirium in children undergoing BIS-guided anaesthesia with desflurane versus sevoflurane using the Paediatric Anaesthesia Emergence Delirium Scale (PAED scale)Timepoint: 10 minutes and 30 minutes after extubation

Secondary

MeasureTime frame
To compare time to discharge from post-anaesthesia care unit (PACU) and adverse events associated with both the study anaesthetic agentsTimepoint: 1 hour after extubation

Countries

India

Contacts

Public ContactA Chaitanya Pratyusha

All India Institute of Medical Sciences

chaitanyapa9@gmail.com9063571725

Outcome results

None listed

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