Comparative Study of Bispectral Index (BIS) Values Obtained From Standard Frontal Position and Alternative Infra-orbital Position During Total Intravenous Anaesthesia (TIVA).
Primary Purpose
Intraoperative Awareness
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Bispectral index
Sponsored by
About this trial
This is an interventional diagnostic trial for Intraoperative Awareness
Eligibility Criteria
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 The patient who had interruption of BIS monitoring of any BIS sensor location at any time frame will be withdrawn from the study.
Sites / Locations
- School Of Medical Sciences, Health Campus, Universioti Sains Malaysia
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
frontal BIS
infraorbital BIS
Arm Description
frontal BIS is a standard position
Infraorbital BIS is a comparator to find agreement with standard location
Outcomes
Primary Outcome Measures
agreement between frontal BIS vs infraorbital BIS
measurements of BIS values on both placement
Secondary Outcome Measures
correlation between frontal BIS vs infraorbital BIS
to find correlation between both measurement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05441644
Brief Title
Comparative Study of Bispectral Index (BIS) Values Obtained From Standard Frontal Position and Alternative Infra-orbital Position During Total Intravenous Anaesthesia (TIVA).
Official Title
Comparative Study of Bispectral Index (BIS) Values Obtained From Standard Frontal Position and Alternative Infra-orbital Position During Total Intravenous Anaesthesia (TIVA).
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
May 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 institution Human Research and Ethics Committee (study protocol code: USM/JEPeM/20060307).
2.2 Study Population We recruited 71 patients who were eligible to be enrolled in this study from November 2020 to October 2021. 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.
The baseline demographic data of patients were extracted from their medical chart. Demographic data include their age, gender, BMI, ASA physical status and type of surgery.
2.3 Study Method Before induction of anaesthesia, we applied two BIS sensors on each patient at different location (frontal & infra-orbital) and connected two different BIS monitor. Frontal sensors were applied with circle 1 at the centre of forehead, circle 2 2.8cm lateral to circle 1, circle 3 on the corner of the eye and circle 4 in between circle 2 and circle 3 (Picture 1(A)). Infra-orbital sensors were applied with circle 1 across the nose bridge, circle 2 adjacent to circle 1, circle 3 medial from the frontally placed third electrode and circle 4 in between circle 2 and 3 (Picture 1 (B)). Anaesthesia was induced with TCI remifentanil at initial target concentration at 2ng/ml up to 4ng/ml followed with TCI propofol at initial target concentration at 4mcg/ml then titrated upwards to loss of consciousness and intravenous (IV) rocuronium 1.0 mg/kg for muscle relaxant and endotracheal intubation. Anaesthesia was maintained with propofol infusion at target plasma concentration of 3-6mcg/ml and remifentanil 1-8ng/ml; Intra-operative analgesia included IV paracetamol 1g, IV parecoxib 40mg and IV morphine 0.05-0.1mg/kg. At the end of surgery, patients were reversed with IV neostigmine 0.05 mg/kg and atropine 0.02mg/kg. BIS values from each BIS monitor during awake, at loss of consciousness (LOC), after intubation, after the start of surgical incision, every 30 minutes during the intraoperative period (maintenance), after cessation of TCI propofol at which the plasma concentration of propofol is 1.5mcg/ml (emergence) and at extubation were recorded. The frontal BIS was used to guide the depth of anaesthesia, with deep (BIS < 45), moderate (BIS 45 to 60) and mild hypnosis (BIS >60).
2.4 Sample Size In order to determine the Kappa agreement for Pearson's correlation between BIS values obtained from frontal versus the infra-orbital sensor position, using t-test, the sample size would be determined with parameter of effect 0.3, an alpha of 0.05 and a power of 80%. The sample size required was 64 patients and with the estimation of 10% drop-out rate, the total number would be 71 patients.
In order to determine the relationship between BIS values obtained from frontal versus the infra-orbital sensor position, using linear regression, the sample size would be determined with parameter of effect size 0.15, an alpha of 0.05 and a power of 80%. The sample size required was 55 patients.
To satisfy both outcomes, the final sample size for this study would be 71 patients.
2.5 Statistical Analysis Data were recorded and analyzed using SPSS for Window version 22.0. Descriptive statistics were used to summarize the socio-demographic characteristics of subjects. Numerical data were presented as mean (SD) or median (IQR) based on their normality distribution. Categorical data were presented as number and percentage. Correlation of the numerical data obtained from the two different groups were analyzed using Pearson's correlation and scatter plot analysis. Relationship between data obtained from the two groups was determined using simple linear regression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Awareness
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
two way mixed effect model; aggreement study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
frontal BIS
Arm Type
Placebo Comparator
Arm Description
frontal BIS is a standard position
Arm Title
infraorbital BIS
Arm Type
Active Comparator
Arm Description
Infraorbital BIS is a comparator to find agreement with standard location
Intervention Type
Device
Intervention Name(s)
Bispectral index
Intervention Description
A new placemewnt to monitor intraoperative BIS
Primary Outcome Measure Information:
Title
agreement between frontal BIS vs infraorbital BIS
Description
measurements of BIS values on both placement
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
correlation between frontal BIS vs infraorbital BIS
Description
to find correlation between both measurement
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
School Of Medical Sciences, Health Campus, Universioti Sains Malaysia
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
there will be upcoming research related to current research
Learn more about this trial
Comparative Study of Bispectral Index (BIS) Values Obtained From Standard Frontal Position and Alternative Infra-orbital Position During Total Intravenous Anaesthesia (TIVA).
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