Comparative Study of Bispectral Index (BIS) Values Obtained From Standard Frontal Position and Alternative Infra-orbital Position During Total Intravenous Anaesthesia (TIVA).
1 other identifier
interventional
71
1 country
1
Brief Summary
A study to find agreement of the infraorbtal BIS placement as compared to standard frotal placement
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedFirst Submitted
Initial submission to the registry
June 27, 2022
CompletedFirst Posted
Study publicly available on registry
July 1, 2022
CompletedJuly 1, 2022
June 1, 2022
1.5 years
June 27, 2022
June 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
agreement between frontal BIS vs infraorbital BIS
measurements of BIS values on both placement
intraoperative
Secondary Outcomes (1)
correlation between frontal BIS vs infraorbital BIS
intraoperative
Study Arms (2)
frontal BIS
PLACEBO COMPARATORfrontal BIS is a standard position
infraorbital BIS
ACTIVE COMPARATORInfraorbital BIS is a comparator to find agreement with standard location
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School Of Medical Sciences, Health Campus, Universioti Sains Malaysia
Kubang Kerian, Kelantan, 16150, Malaysia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer and Neuroanaesthesiologist
Study Record Dates
First Submitted
June 27, 2022
First Posted
July 1, 2022
Study Start
June 30, 2020
Primary Completion
December 31, 2021
Study Completion
May 30, 2022
Last Updated
July 1, 2022
Record last verified: 2022-06