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To see agreement between 2 EEG based monitors between 2 anaesthetic techniques in abdominal surgeries

Evaluating correlation between Sedline and Entropy EEG based monitors on objective depth of Total Intravenous Anaesthesia (TIVA ) and Inhalational anaesthesia in abdominal surgeries: A prospective randomised trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076648
Enrollment
60
Registered
2024-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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 Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Propofol Entropy (PE) group: Patients will receive intial IV propofol infusion dose at 50 µg/kg/min.The dose will be adjusted so as to maintain entropy in range 40 to 60 Intervention

Sponsors

Singam Geetha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1-2 Elective abdominal surgeries

Exclusion criteria

Exclusion criteria: 1.Neurologic disease 2.emergency/neurosurg/frontal sinus surgery 3. deformities/devices preventing application of EEG sensors to forehead 3. Patients having developmental delay 4.haemodynamic instability, Hypo/ Hyperthermia 5.Preoperative anxiety 6.receiving medications altering EEG 7.Surgery above 6 hrs duration

Design outcomes

Primary

MeasureTime frame
To assess the correlation agreement between Sedline and Entropy monitors during propofol TIVA and sevoflurane inhalational anaesthesiaTimepoint: Baseline, Induction [every 1 min for 5 min using the Modified Observers’ Assessment of Alertness/ Sedation (MOAAS) scale until the patient loses the eyelash reflex and achieves a score of 0], Intubation, peritoneum retraction, 30, 60, 90, 120 min post peritoneum retraction, closure, emergence (every min till MOASS score reaches 4) and extubation

Secondary

MeasureTime frame
1.MAP, HR 2.assess Correlation between propofol sedation and sedline 3.assess correlation between Sevoflurane sedation and Entropy 4.To assess correlation sevoflurane sedation and sedline 5. To assess correlation between propofol sedation and EntropyTimepoint: Baseline, Induction [every 1 min for 5 min using the Modified Observers’ Assessment of Alertness/ Sedation (MOAAS) scale until the patient loses the eyelash reflex and achieves a score of 0], Intubation, peritoneum retraction, 30, 60, 90, 120 min post peritoneum retraction, closure, emergence (every min till MOASS score reaches 4) and extubation (every 1 minute till 5 minutes)

Countries

India

Contacts

Public ContactSingam Geetha

Nizams Institute of Medical Sciences Hyyderabad: Pincode: 500082

singamgeetha11@gmail.com09441043075

Outcome results

None listed

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