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CTRI Number  CTRI/2019/03/018024 [Registered on: 12/03/2019] Trial Registered Prospectively
Last Modified On: 08/03/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   SCALP BLOCK VS PROPOFOL INFUSION FOR HAEMODYNAMIC STABILITY IN NEUROSURGERY CASES. 
Scientific Title of Study   SCALP BLOCK FOR HEMODYNAMIC STABILITY DURING NEUROSURGERY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SNIGDHA KUMARI 
Designation  POSTGRADUATE STUDENT 
Affiliation  LILAVATI HOSPITAL AND RESERCH CENTRE. 
Address  LILAVATI KIRTILAL MEHTA MEDICAL TRUST RESERCH CENTRE, A-791,GROUND FLOOR,BANDRA RECLAMATION ROAD, BANDRA WEST,MUMBAI. 400050 INDIA
LILAVATI KIRTILAL MEHTA MEDICAL TRUST RESERCH CENTRE, A-791,GROUND FLOOR,BANDRA RECLAMATION ROAD, BANDRA WEST,MUMBAI. 400050 INDIA
Mumbai
MAHARASHTRA
400050
India 
Phone  7909059807  
Fax    
Email  snigdhasingh19590@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  FALGUNI SHAH 
Designation  PG GUIDE 
Affiliation  LILAVATI HOSPITAL AND RESERCH CENTRE. 
Address  LILAVATI HOSPITAL AND RESERCH CENTRE ,BANDRA WEST,MUMBAI. 400050 INDIA
LILAVATI HOSPITAL AND RESERCH CENTRE ,BANDRA WEST,MUMBAI. 400050 INDIA
Mumbai
MAHARASHTRA
400050
India 
Phone  7909059807  
Fax    
Email  falgunishah26@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  SNIGDHA KUMARI 
Designation  POSTGRADUATE STUDENT 
Affiliation  LILAVATI HOSPITAL AND RESERCH CENTRE. 
Address  LILAVATI KIRTILAL MEHTA MEDICAL TRUST RESERCH CENTRE, A-791,GROUND FLOOR,BANDRA RECLAMATION ROAD, BANDRA WEST,MUMBAI. 400050 INDIA
LILAVATI KIRTILAL MEHTA MEDICAL TRUST RESERCH CENTRE, A-791,GROUND FLOOR,BANDRA RECLAMATION ROAD, BANDRA WEST,MUMBAI. 400050 INDIA
Mumbai
MAHARASHTRA
400050
India 
Phone  7909059807  
Fax    
Email  snigdhasingh19590@gmail.com  
 
Source of Monetary or Material Support  
LILAVATI HOSPITAL AND RESERCH CENTRE. 
LILAVATI KIRTILAL MEHTA MEDICAL TRUST RESERCH CENTRE, A-791,GROUND FLOOR,BANDRA RECLAMATION ROAD, BANDRA WEST,MUMBAI. 
 
Primary Sponsor  
Name  LILAVATI HOSPITAL AND RESERCH VCENTRE 
Address  BANDRA WEST MUMBAI 400050 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SNIGDHA KUMARI  LIAVATI HOSPITAL AND RESERCH CENTRE.  LILAVATI KIRTILAL MEHTA MEDICAL TRUST RESERCH CENTRE, A-791,GROUND FLOOR,BANDRA RECLAMATION ROAD, BANDRA WEST,MUMBAI.
Mumbai
MAHARASHTRA 		 07909059807

snigdhasingh19590@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
LILAVATI KIRTILAL MEHTA MEDICAL TRUST RESEARCH CENTRE.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I,II,III
WILLING TO PARTICIPATE.
ALL MAJOR CRANIOTOMY CASES.
ABLE TO COMPREHEND AND COOPERATE. 
 
ExclusionCriteria 
Details  PATIENT REFUSAL.
ASA GRADE IV.
ALLERGY TO BUPIVACAINE.
ALCOHOL AND SUBSTANCE ADDICTION.
ANTICOAGULANT MEDICATIONS. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
HEART AND BLOOD PRESSURE.  BEFORE ANESTHESIA INDUCTION, AFTER ANESTHESIA INDUCTION,AFTER INCISION/PINNING,IMMEDEIATE AFTER EXTUBATION,15MIN,30MIN,45MIN,60MIN,90MIN,120MIN AFTER EXTUBATION. 
 
Secondary Outcome  
Outcome  TimePoints 
POST OPERATIVE PAIN USING VAS SCORING SYSTEM.  BEFORE ANESTHESIA INDUCTION, AFTER ANESTHESIA INDUCTION,AFTER INCISION/PINNING,IMMEDEIATE AFTER EXTUBATION,15MIN,30MIN,45MIN,60MIN,90MIN,120MIN AFTER EXTUBATION. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   26/03/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   TITLE:  To compare the hemodynamic response to incision with scalp block VS iv propofol infusion in neurosurgical procedures.
RATIONALE: The incision on scalp is a highly noxious stimulus that cause hemodynamic changes which are undesirable especially in neurosurgical procedures.Hence we decided to compare the hemodynamic  effects of Scalp Block VS Propofol infusion to incision/pinning and to study post operative pain using VAS scoring system.
SETTING: Study carried out in Lilavati Hospital and Reserch Centre.
STUDY DESIGN: Prospective ,randomised study. 
SAMPLE SIZE: 40(divided into 2 groups).
GROUP A: All patient recieving scalp block.
GROUP B: All patents recieving Propofol; infusion.
OUTCOME MEASURES:Following measures will be recorded  during the study- "heart rate and blood pressure" changes preoperatively ,intraoperatively and postoperatively 2 hours after extubation .,along with the VAS scoring for postoperative pain.
STATISCAL ANALYSIS:Data will be analysed using SPSSV15.0(Statistical package for Social Sciences,Version 15.0)Data will be given as Mean +_ SD(n) for continous data and number(percentage) for categorical data..Comparison of means will be carried out by Student’s unpaired test for numerical data .Fischer Exact Proabibility test or Chisquare test will be applied to compare percentages for categorical data .Paired t test will be applied to compare MEANS AT VARIOUS TIME POINTS FOR SAME PATIRNTS.Mann Whitney U test  and Wilcoxan Signed Rank test will be applied to non normal data.All statistical tests will be two tailed.Alpha  Level of significance will be taken as P<0.05.

 
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