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Incidence of Intraoperative Awareness in Indian Patient Population

NCT03571945 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

  • Intraoperative Awareness

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

Sponsors & Collaborators

  • Sir Ganga Ram Hospital

    lead OTHER

Principal Investigators

  • Amitabh Dutta, MD, PhD · Sir Ganga Ram Hospital

  • Jayashree Sood, MD,FFRCA · Sir Ganga Ram Hospital

  • Nitin Sethi, DNB · Sir Ganga Ram Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2028-03-02
Completion
2028-03-02
FDA Device
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03571945 on ClinicalTrials.gov