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A Clinical trial to understand relationship between patient unawareness and administration of sevoflurane in children undergoing heart operation.

RELATIONSHIP BETWEEN SEVOFLURANE END OXYGENATOR CONCENTRATION AND ENTROPY GUIDED SEVOFLURANE ADMINSTRATION DURING CARDIOPULMONARY BYPASS SURGERY IN PAEDIATRIC POPULATION: A RANDOMISED CONTROL TRIAL - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057868
Enrollment
62
Registered
2023-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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: Sevoflurane concentration (%w/v) will be adjusted to maintain target entropy value of 70 during cardiopulmonary bypass. Control Intervention1: Standard institutional protoc

Sponsors

Armed Forces Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Elective paediatric patients (0-14 years) undergoing cardiac surgery on CPB.2.Written informed consent.

Exclusion criteria

Exclusion criteria: 1.An active infection with temperature 38.0C 2.History of a neurological disease 3.Previously diagnosed with renal and hepatic disorder 4.Emergency surgery 5.Any kind of diagnosed or suspected syndrome 6.Deep hypothermic circulatory arrest

Design outcomes

Primary

MeasureTime frame
Changes in sevoflurane end oxygenator concentration with entorpy-guided sevoflurane administration.Timepoint: At the time of induction At the time of skin incision At the time of sternotomy At the time of starting of CPB At the time of cross clamping of Aorta At 10 minutes intervals during CPB At the time of removal of cross clamp from Aorta At the time of stopping CPB At the time of skin closure

Secondary

MeasureTime frame
IBP MAP CPB flow Sevoflurane dial concentration (% w/v) Body Temperature ETCO2 FiO2 VIS Timepoint: At 10 minutes intervals during CPB

Countries

India

Contacts

Public ContactDR RAHUL YADAV

Army Institute for Cardiothoracic Sciences

vs_joshi2003@yahoo.com9762024720

Outcome results

None listed

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