| CTRI Number |
CTRI/2016/06/007050 [Registered on: 29/06/2016] Trial Registered Prospectively |
| Last Modified On: |
14/12/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the relation between finger tip blood flow with pulse and blood pressure in patients operated for brain surgery under general anaesthesia. |
|
Scientific Title of Study
|
Co relation of perfusion index with non invasive haemodynamic parameters to evaluate stress response in neurosurgical cases under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devangi Parikh |
| Designation |
Associate Professor- Anaesthesiology |
| Affiliation |
Lokmanya Tilak Municipal General Hospital |
| Address |
Department of Anaesthesia, College building, 4th floor
Lokmanya Tilak Municipal Medical College and General Hospital
Dr Babasaheb Ambedkar Road
Sion(West)
Same as Address 1
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9820471638 |
| Fax |
|
| Email |
sdevangi10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemangi Karnik |
| Designation |
Professor- Anaesthesiology |
| Affiliation |
Lokmanya Tilak Municipal General Hospital |
| Address |
Department of Anaesthesia, College building, 4th floor
Lokmanya Tilak Municipal Medical College and General Hospital
Dr Babasaheb Ambedkar Road
Sion(West)
Same as address 1
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9324501900 |
| Fax |
|
| Email |
dr_hemangi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Janhavi Gholap |
| Designation |
Resident in Anaesthesiology |
| Affiliation |
Lokmanya Tilak Municipal General Hospital |
| Address |
Department of Anaesthesia, College building, 4th floor
Lokmanya Tilak Municipal Medical College and General Hospital
Dr Babasaheb Ambedkar Road
Sion(West)
Same as address 1
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9987755770 |
| Fax |
|
| Email |
janhavigholap08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal Medical College and General Hospital
Dr Babasaheb Ambedkar Road
Sion(West)
Mumbai-400022
Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Lokmanya Tilak Municipal General Hospital |
| Address |
Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022 |
| 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 |
| Dr Devangi Parikh |
Neurosurgical Operation Theatre |
Lokmanya Tilak Municipal General Hospital
Hospital Building number 2, third floor.
Dr Babasaheb Ambedkar Road, Sion West, Mumbai-400022
Mumbai
MAHARASHTRA |
9820471638
sdevangi10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Staff research and society, Lokmanya Tilak Municipal Medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Studying the parameters viz. heart rate, blood pressure and perfusion index to evaluate stresss response in patients undergoing neurosurgical procedures, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18-65 years
2.ASA I AND II |
|
| ExclusionCriteria |
| Details |
1. pregnant female
2. h/o chronic hypertension
3. h/o diabtes mellitus
4. h/o peripheral vascular disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to establish whether changes in perfusion index can be used as a new method to evaluate stress response in neurosurgical cases.Perfusion index will be correlated with heart rate at specific time points. |
1) At the time of intubation-readings noted every minute for five minutes
2)At the time of insertion of skull pins- readings noted every minute for five minutes
3) At the time of skin incision- readings noted every minute for five minutes
4) At the time of craniotomy-readings noted every minute for five minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare sensitivity and specificity of perfusion index with conventional non invasive haemodynamic parameters(ie heart rate, systolic blood pressure) during periods of stress in neurosurgical cases under general anaesthesia. |
1)At time of intubation
2)At time of insertion of skull pins
3)At time of skin incision
4)At time of craniotomy.
Readings of perfusion index, heart rate,sytolic blood pressure will be noted every minute for five minutes.
|
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/07/2016 |
| 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="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Perfusion index is a non invasive and indirect measure of peripheral perfusion obtained from pulse oximeter. It is calculated by expressing the pulsatile signal as a percentage of the non pulsatile signal, both of which are derived from the amount of infrared(940) light absorbed, It is measured at specific site such as fingers and toes. It can be used to assess peripheral perfusion dynamics due to changes in the sympathetic tone.
The concept of neuroanaesthesia includes several principles, haemodynamic stability perioperatively being one of utmost importance. Anaesthetic maneuvers like direct laryngoscopy, tracheal intubation and extubation involve sympathetic stimulation. Surgical interventions in the form of skull pins, incision and craniotomy are also critical points of intense stimulation. All these cause marked alterations in mean arterial flow, cerebral blood flow and intracranial pressure which may result in raised Intracranial pressure with reduction in cerebral perfusion pressure. Perioperative hypertension is associated with intracranial bleeds Thus, the prevention of haemodynamic responses to nociceptive stimuli to preserve cerebal haemostasis is of utmost importance. The aim of this study is to establish whether changes in perfusion index can be used a a new method to evaluate stress response during neurosurgery and to compare its reliability with conventional non invasive haemodynamic parameters( heart rate, systolic blood pressure) during period of stress under general anaesthesia. |