| CTRI Number |
CTRI/2012/07/002788 [Registered on: 11/07/2012] Trial Registered Prospectively |
| Last Modified On: |
29/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Autonomic nervous system in patients with neurosurgical problems |
|
Scientific Title of Study
|
Heart rate variability as a tool to assess autonomic nervous system in patients with neurosurgical disorders. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Item No. VI, Sl.No.6.06 Clinical Neuro Sciences |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Radhakrishnan |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of euroanaesthesia
National Institute of Mental Health and Neuro Sciences, Hosur Road, Bangalore,
Bangalore
KARNATAKA
560029
India |
| Phone |
09632589296 |
| Fax |
|
| Email |
mrks1974@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Radhakrishnan |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of euroanaesthesia
National Institute of Mental Health and Neuro Sciences, Hosur Road, Bangalore,
Bangalore
KARNATAKA
560029
India |
| Phone |
09632589296 |
| Fax |
|
| Email |
mrks1974@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Radhakrishnan |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of euroanaesthesia
National Institute of Mental Health and Neuro Sciences, Hosur Road, Bangalore,
Bangalore
KARNATAKA
560029
India |
| Phone |
09632589296 |
| Fax |
|
| Email |
mrks1974@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of science and Technology (Awaiting funding approval)
Technology Bhavan, New Mehrauli Road, New Delhi - 110016 |
|
|
Primary Sponsor
|
| Name |
National Institute Of mental Health and Neuro Sciences |
| Address |
Hosur Road, Bangalore, Karnataka, 560029
Telephone: 080-26995000,
E mail ID: http://mail.nic.in
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 M Radhakrishnan |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
Dr. M. Radhakrishnan
Associate Professor
Department of Neuroanaesthesia
National Institute of Mental Health and Neuro Sciences, Hosur Road, Bangalore, Karnataka, 560029
Bangalore
KARNATAKA |
09632589296
mrks1974@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cervical myelopathy, anuerysmal sub arachnoid hemorrhage, craniopharyngioma, hydrocephalus, posterior fossa and supratentorial tumour, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Males or females ≥ 18 years
Patients requiring surgery for Cervical spine pathologies, Posterior fossa and supratentorial tumors, Hydrocephalus, Craniopharyngiomas, subarachnoid hemorrhage.
Patients undergoing lumbar spine surgeries (reference group)
|
|
| ExclusionCriteria |
| Details |
• Patients having cardiac pacemaker, abnormal rhythms
• Patients on beta blocker therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Heart rate variability measured in terms of time domain, frequency domain and non linear model |
• 24 hours prior to surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Incidence of heart rate changes (±20%) and blood pressure changes (±20%).
|
24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="340" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2012 |
| Date of Study Completion (India) |
01/07/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Autonomic nervous system reflexly controls the vital functions of the human body and is controlled by the higher centers in the brain. Lesions in these pathways can result in increased morbidity and mortality of these patients undergoing surgery under anesthesia. Assessment of this system by means of heart rate variability will provide insight into the functioning of the autonomic nervous system and can be used to optimize patient care. Adult patients undergoing surgery for cervical myelopathy, supratentorial and infratentorial tumors, and subarachnoid hemorrhage will be recruited for the project. Five minute recordings of ECG will be done either before or on the day of surgery using surface electrodes. R-R interval will be calculated using proprietary software. With this data, both linear and non models would be used to derive various parameters of heart rate variability. This would be correlated with intraoperative hemodynamic instability and condition of patients at discharge. |