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CTRI Number  CTRI/2016/08/007168 [Registered on: 10/08/2016] Trial Registered Retrospectively
Last Modified On: 09/08/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of magnesium and lignocaine on postoperative pain. 
Scientific Title of Study   Effect of magnesium and lignocaine on postcraniotomy pain: a comparative, randomised, double-blinded, placebo-controlled study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Charu Mahajan 
Designation  Assistant professor 
Affiliation  AIIMS 
Address  Department of Neuroanaesthesiology and Critical Care, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  charushrikul@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Charu Mahajan 
Designation  Assistant professor 
Affiliation  AIIMS 
Address  Department of Neuroanaesthesiology and Critical Care, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  charushrikul@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Charu Mahajan 
Designation  Assistant professor 
Affiliation  AIIMS 
Address  Department of Neuroanaesthesiology and Critical Care, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  charushrikul@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS 
Address  AIIMS, New Delhi, India. 
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 
Dr Charu Mahajan  AIIMS, New Delhi.  Department of Neuroanaesthesiology and Critical care, AIIMS, New Delhi, India
New Delhi
DELHI 
09868398588

charushrikul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients having supratentorial tumours scheduled for craniotomy and excision of tumour ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lignocaine  Group B will receive Lignocaine bolus of 1.5 mg/Kg followed by 2 mg/Kg/hr iv infusion till the surgery ends  
Intervention  Magnesium  Group A will receive a bolus of magnesium sulphate(50%)50 mg/Kg followed by infusion 25 mg/Kg/hr intravenously till the surgery ends  
Comparator Agent  Normal Saline  Patients will receive 10 ml bolus of normal saline followed by intravenous infusion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having supratentorial tumours undergoing elective craniotomy and excision of tumour. 
 
ExclusionCriteria 
Details  patients having cardiovascular, respiratory, renal or hepatic disease, on treatment with calcium channel blockers, having brain tumour larger than 30 mm in any dimension, having mental diability, neurological or cognitive deficits (precluding their use of patient controlled analgesia device, having allergy to study medications, having history of myopathy or substance abuse. Patients who are mechanically ventilated in the postoperative period will be excluded from the final analysis.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of magnesium and lignocaine on postoperative pain as assessed using visual analogue scale (VAS).  To evaluate the effect of magnesium and lignocaine on postoperative pain as assessed using visual analogue scale (VAS). 
 
Secondary Outcome  
Outcome  TimePoints 
To determine total fentanyl consumption  intraoperative and 24 hours postoperatively 
To asees S100 B levels  Baseline, at end of surgery and at 24 hrs postoperatively. 
Side effects of study drugs if any  intraoperative period till 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   01/09/2015 
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)  Open to Recruitment 
Publication Details    
Brief Summary   Cranoitomy is often associated with moderate to severe pain in about 69% of patients on the first postoperative day. Intravenous magnesiuma and lignocaine have been used in various types of surgery and have been found to reduce perioperative pain as assessed by visual analogue scale and decreased opioid requirement perioperatively. Both these drugs also have cerebral protectent effect. Although these drugs have been used individually in neurosurgical cases for providing analgesia, their comparative study in patients undergoing craniotomy has been not performed till date. Thus, this study wll be undertaken to compare the analgesic efficacy of magnesium with lignocaine in patients undergoing craniotomy for supratentorial tumours and also to assess the effect of these drugs on S 100 B level, an indication of cerebral protectant effect. 
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