| CTRI Number |
CTRI/2025/06/089550 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Can Pupil Size and Heart Rate Help Monitor Sedation in Patients Given Dexmedetomidine |
|
Scientific Title of Study
|
Exploring Heart Rate Variability and Pupillometry as Predictors of Sedation Depthin Dexmedetomidine Sedation in Non-Operating Room Anaesthesia (NORA) Settings |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Suresh Naik |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Faculty Building Third Floor Department of Neuroanaesthesia and Neurocritical care National Institute of Mental Health and Neurosciences Hosur Main Road Bangalore
Bangalore
KARNATAKA
Faculty Building Third Floor Department of Neuroanaesthesia and Neurocritical care National Institute of Mental Health and Neurosciences Hosur Main Road Bangalore
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560028
India |
| Phone |
9986308719 |
| Fax |
|
| Email |
neurodocms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta Suresh Naik |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Faculty Building Third Floor Department of Neuroanaesthesia and Neurocritical care National Institute of Mental Health and Neurosciences Hosur Main Road Bangalore
Bangalore
KARNATAKA
Faculty Building Third Floor Department of Neuroanaesthesia and Neurocritical care National Institute of Mental Health and Neurosciences Hosur Main Road Bangalore
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560028
India |
| Phone |
9986308719 |
| Fax |
|
| Email |
neurodocms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Suresh Naik |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Faculty Building Third Floor Department of Neuroanaesthesia and Neurocritical care National Institute of Mental Health and Neurosciences Hosur Main Road Bangalore
Bangalore
KARNATAKA
Faculty Building Third Floor Department of Neuroanaesthesia and Neurocritical care National Institute of Mental Health and Neurosciences Hosur Main Road Bangalore
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560028
India |
| Phone |
9986308719 |
| Fax |
|
| Email |
neurodocms@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka- 560029,India |
|
|
Primary Sponsor
|
| Name |
Shweta Suresh Naik |
| Address |
Faculty Building Third Floor Department of Neuroanaesthesia and Neurocritical Care National Institute of Mental Health and Neurosciences Hosur Main road Bengaluru Karnataka |
| Type of Sponsor |
Other [individual] |
|
|
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 |
| Dr Shweta Suresh Naik |
National Institute of Mental Health and Neurosciences |
Department of Neuroanaesthesia and Neurocritical Care National Institute of Mental Health and Neurosciences Hosur Main road Bengaluru Karnataka-560028
Bangalore
Bangalore
KARNATAKA |
9986308719
neurodocms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Mental Health and Neurosciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Paediatric and Adults aged 2 to 70 years.
2. Scheduled for a procedure requiring sedation with dexmedetomidine in a NORA setting.
|
|
| ExclusionCriteria |
| Details |
1. Patients with pre-existing cardiovascular, neurological, or ocular conditions that might interfere with
accurate HRV or pupillometry measurements.
2. Patients with a history of severe allergic reactions to dexmedetomidine or contraindications to its use.
3. Patients currently on medications known to significantly alter autonomic function.
4. Refusal of consent
5. Change in sedation protocol from dexmedetomidine
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the changes in HRV as a response to dexmedetomidine administration in NORA settings |
baseline, start of sedation, end of sedation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To correlate HRV changes with clinically assessed sedation levels using the Richmond Agitation-Sedation Scale (RAAS). |
baseline, start of sedation, end of sedation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/07/2025 |
| 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="2"
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 - NO
|
|
Brief Summary
|
This prospective observational study aims to evaluate whether heart rate variability and pupillometry can serve as reliable predictors of sedation depth in adult patients receiving dexmedetomidine sedation in non-operating room anaesthesia (NORA) settings. The study will include patients undergoing procedures such as MRI or minor interventions outside the operating room where dexmedetomidine is used for conscious sedation. Standard sedation scores such as the Richmond Agitation Sedation Scale (RASS) will be used as clinical reference. Physiological parameters including heart rate variability and pupil size will be recorded at predefined time points during sedation. The correlation between these objective parameters and clinical sedation scores will be analyzed to assess their predictive value. The study aims to contribute to safer and more individualized sedation practices in NORA environments. |