Status:

COMPLETED

Comparative Study of Bispectral Index (BIS) Values Obtained From Standard Frontal Position and Alternative Infra-orbital Position During Total Intravenous Anaesthesia (TIVA).

Lead Sponsor:

Universiti Sains Malaysia

Conditions:

Intraoperative Awareness

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

A study to find agreement of the infraorbtal BIS placement as compared to standard frotal placement

Detailed Description

2.1 Study Design This was a prospective, cross-sectional study conducted in single centre, University Hospital. The study protocol was reviewed and granted approval for implementation by the instituti...

Eligibility Criteria

Inclusion

  • The inclusion criteria were consented adults between the age of 18 and 60 years old, BMI \> 18 and \<30 kg/m2 and ASA physical status I or II underwent general elective surgery under general anaesthesia. We excluded patients who were going for neurosurgery, maxillofacial or facial surgical procedures because the operation site may interfere with the BIS sensors placement. Patients with a history of disabling central nervous or cerebrovascular disease, those on psychiatric medication or central nervous system active drugs, and those who had undergone neurosurgical procedure were also excluded. The patient who had interruption of BIS monitoring of any BIS sensor location at any time frame will be withdrawn from the study.

Exclusion

    Key Trial Info

    Start Date :

    June 30 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 30 2022

    Estimated Enrollment :

    71 Patients enrolled

    Trial Details

    Trial ID

    NCT05441644

    Start Date

    June 30 2020

    End Date

    May 30 2022

    Last Update

    July 1 2022

    Active Locations (1)

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    School Of Medical Sciences, Health Campus, Universioti Sains Malaysia

    Kubang Kerian, Kelantan, Malaysia, 16150