| CTRI Number |
CTRI/2025/10/095990 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Screening |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing two methods to assess the level of sedation in patients to find the more accurate technique.”
|
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Scientific Title of Study
|
A Study to compare Bispectral index objective sedation scale versus Richmond agitation sedation scale (RAAS subjective scale) in critically ill mechanically ventilated patients for clinical evaluation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sathya Narayanan K |
| Designation |
DM Critical care medicine , senior resident |
| Affiliation |
Bangalore Medical College and Research Institute, Bangalore |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE
Bangalore
Bangalore
KARNATAKA
560022
India |
| Phone |
09597447444 |
| Fax |
|
| Email |
sathyavaan4444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIJAYA KUMAR |
| Designation |
Professor and Head , Department of critical care medicine |
| Affiliation |
Bangalore Medical College and Research Institute, Bangalore - BANGALORE |
| Address |
Department of Critical Care Medicine , 5th floor , Trauma and emergency care centre Bangalore Medical College
Bangalore
Bangalore
KARNATAKA
560022
India |
| Phone |
09597447444 |
| Fax |
|
| Email |
viji2751977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sathya Narayanan K |
| Designation |
DM Critical care medicine , senior resident |
| Affiliation |
Bangalore Medical College and Research Institute, Bangalore |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE
Bangalore
Bangalore
KARNATAKA
560022
India |
| Phone |
09597447444 |
| Fax |
|
| Email |
sathyavaan4444@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college & Research institute, Karnataka ,India pin code - 560022 |
|
|
Primary Sponsor
|
| Name |
Department of Critical Care Medicine |
| Address |
5th floor , Trauma and emergency care centre , Bangalore Medical College , BMCRI , Bangalore , Karnataka, India - 560022 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSathya NarayananK |
Bangalore Medical College & Research Institute |
Department of Critical Care Medicine , 5th floor , Trauma and emergency care centre , Bangalore Medical College, Fort, K.R. Road, Bangalore, Karnataka, India · 560 002 · Krishna Rajendra Road
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
09597447444
sathyavaan4444@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Bangalore Medical College & Research Institute e, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J17||Pneumonia in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BIS |
The BIS electrode placement above the bridge of the nose, over the temple area and between the corner of the eye and the hairline will be attached continuously in all patients included in the study for 3 days. |
| Intervention |
RASS |
The RASS score will be read every 4th hourly while in corresponding RASS will be recorded. All the outcome parameters will be recorded for the duration of 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 to 65 years and Mechanically ventilated for more than 48 hours.
2.Patients/ Parents/ Caregivers who are willing to give informed consent
3.Patients with renal and hepatic disorder for subgroup analysis.
|
|
| ExclusionCriteria |
| Details |
1. Head injuries
2. Required Deep (Barbiturate Coma) Sedation for Status Epilepticus.
3.Patients known to have any focal brain disease or abnormal electrical brain activities such as epilepsy .
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sensitivity , Specificity, Positive predictive & negative predictive values of BIS and clinical sedation scales.
Correation between BIS and RASS.
|
every 4 hourly till extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Whether BIS monitoring can reduce sedative dose requirements while preventing undersedation events. |
total volume in ml of drug infused in the 24 h study period;. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sathyavaan4444@gmail.com].
- For how long will this data be available start date provided 15-10-2025 and end date provided 25-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
| Delirium being an independent risk factor for ICU mortality can result in over sedation, increased duration of mechanical ventilation and increased length of ICU stay.
Sedatives are commonly administered to ICU patients to control agitation. Sedatives must be titrated to attain either light sedation (i.e., the patient is arousable and able to consciously obey simple commands) or profound sedation (i.e., the patient is unresponsive to noxious stimuli), contingent upon the patient’s clinical status and expected ICU length.Nonetheless, tools such as the Richmond Agitation–Sedation Scale (RASS) require subjective evaluation, potentially leading to measurement variability and subsequent clinical actions. The bispectral index (BIS) is an objective measure for evaluating levels of awareness, frequently employed as an anaesthetic tool, with its use also expanding to the intensive care unit (ICU). The existing published findings are insufficient to warrant the extensive use of the BIS in patients with organophosphorus poisoning presenting with delirium |
|