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CTRI Number  CTRI/2020/10/028199 [Registered on: 01/10/2020] Trial Registered Prospectively
Last Modified On: 25/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   We are here to compare the use of IV magnesium sulphate and bupivacaine scalp block to reduce the frequent change in blood pressure and heart rate in patients undergoing head surgery under general anaesthesia. 
Scientific Title of Study   Comparison of intravenous magnesium sulphate and scalp block in attenuating hemodynamic response following skull pin application in patients undergoing craniotomy 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 Astha Sahu 
Designation  Post graduate student 
Affiliation  ABVIMS and Dr RML Hospital New Delhi 
Address  House no 51/a ground floor varinder nagar
Department of Anaesthesiology,old building ground floor OT.Room no-11
New Delhi
DELHI
110058
India 
Phone  9560183218  
Fax    
Email  dr.asthasahu09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Namita Arora 
Designation  Associate Professor 
Affiliation  ABVIMS and Dr RML Hospital New Delhi 
Address  Department of anaesthesiology ABVIMS and Dr RML Hospital, New Delhi Old building ground floor OT Room no-11

New Delhi
DELHI
110001
India 
Phone  9868219619  
Fax    
Email  namitaarora16@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Astha Sahu 
Designation  Post graduate student 
Affiliation  ABVIMS and Dr RML Hospital New Delhi 
Address  House no 51/A street no.9 varinder Nagar new delhi
Department of Anaesthesiology,old building ground floor OT,room no-11
New Delhi
DELHI
110058
India 
Phone  9560183218  
Fax    
Email  dr.asthasahu09@gmail.com  
 
Source of Monetary or Material Support  
ABVIMS And Dr.RML Hospital.New Delhi 110001 
 
Primary Sponsor  
Name  ABVIMS and Dr RML Hospital 
Address  Department of Anaesthesiology Baba Kharak Singh Road, New Delhi-110001  
Type of Sponsor  Government medical college 
 
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 
Dr Astha sahu  ABVIMS And Dr.RML Hospital  Department of anaesthesiology Old building,ground floor OT room no-11
New Delhi
DELHI 		 9560183218

dr.asthasahu09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee  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 
Intervention  IV Magnesium sulphate to be given 10 min prior to scalp pin insertion  Dose-50mg/kg magnesium sulfate in 100ml Normal saline. Frequency route of administration-intravenous given once. Duration-10 min.  
Comparator Agent  Local infiltration of bupivacaine as scalp block prior to scalp pin insertion  Dose-20-30ml of 0.5% Bupivacaine. Route of administration-subcutaneous infiltration at scalp pin insertion site.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status I and II.

Scheduled for elective craniotomies 
 
ExclusionCriteria 
Details  1.Emergency surgeries
2.Intracranial aneurysm surgery.
3.History of magnesium sulphate consumption or allergy.
4.Allergy to bupivacaine.
5.Renal and Hepatic disease. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
MAP and HR  Baseline,at the time of pin insertion,5s,10s,30s,60s,120s,180s,300s,10min,15min and 30min after pin insertion. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To look for any need of rescue drug used for attenuating hemodynamic response(0.5mg/kg propofol)
2.Adverse effect of drugs. 		 After30s,60s,90s,120s,180s,300s,15min and 30min if patients seems to be hemodynamically unstable 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   06/10/2020 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is a randomized comparative study comparing IV magnesium sulphate @50mg/kg in 100 ml Normal saline over 10 min and  Bupivacaine scalp block(20-30ml 0f 0.5%)local infiltration at pin insertion site in 60 patients(30 in each group)for attenuation of hemodynamic response following scalp pin insertion in patients undergoing craniotomy under general anaesthesia.It is conducted at Atal Bihari Vajpaiyee Institute Of Medical Sciences and Dr RML Hospital,New Delhi,India.
The primary outcome to measure MAP and Heart rate at various interval of time after application of pins.The secondary outcome to look for any need of rescue drug for attenuating hemodynamic response and adverse effect of drugs.
 
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