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SUSPENDED
NCT03571945
NA

Incidence of Intraoperative Awareness in Indian Patient Population

Sponsor: Sir Ganga Ram Hospital

View on ClinicalTrials.gov

Summary

The profiling of bi-spectral index (BIS) monitored facilitation of general anesthesia (GA), including, anesthesia induction and maintenance of GA depth state, emergence characteristics, and postoperative recovery parameters, is now extensively available. However, majority of the data supporting the use of BIS have emanated from western Caucasian patient population. Though research on BIS monitoring have also emerged from Asian subcontinent, the data generated, at the best, is too scattered, random, and non-homogenous to reflect onto how BIS guidance fares in Asians on a population basis. We aim to undertake a multi-centric prospective cohort trial in Asian patient population to analyze as to whether BIS guidance toes the profiling and the evidence in Caucasians.

Official title: Impact of Bi-spectral Index Guided Inhalation Anaesthesia on the Incidence of Intraoperative Awareness in Indian Patient Population: A Prospective, Randomised, Multi-Centric Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2018-10-10

Completion Date

2028-03-02

Last Updated

2026-04-27

Healthy Volunteers

No

Interventions

DEVICE

Bi-spectral Index (BIS QUATRO REF #186-0106)

GA will be monitored and controlled with Bi-spectral index (BIS).

DEVICE

End tidal anaesthesia gas concentration (ETAG)

GA will be monitored and controlled with end-tidal anaesthesia gas concentration

Locations (5)

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, India

Prof. L Parthasarathy

Chennai, Tamil Nadu, India

Post Graduate Institute For Medical Education & Research

Chandigarh, India

Apollo Gleneagles Hospital

Kolkata, India

P D Hinduja Hospital & Medical Research Centre

Mumbai, India