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CTRI Number  CTRI/2023/03/050300 [Registered on: 03/03/2023] Trial Registered Prospectively
Last Modified On: 16/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effect of intraoperative magnesium sulphate in craniotomy patients 
Scientific Title of Study   Effect of intraoperative magnesium sulphate infusion on total anaesthetic requirement and postoperative analgesia in craniotomy patients: A prospective interventional 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 Manoj Kumar Giri 
Designation  Professor 
Affiliation  DR RMLIMS 
Address  Department of Anaesthesiology Administrative block Dr RMLIMS campus Vibhuti Khand Gomti Nagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  9044479649  
Fax    
Email  drmanoj.giri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manoj Kumar Giri 
Designation  Professor 
Affiliation  DR RMLIMS 
Address  Department of Anaesthesiology Administrative block Dr RMLIMS campus Vibhuti Khand Gomti Nagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  9044479649  
Fax    
Email  drmanoj.giri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nidhi Varma 
Designation  Junior Resident 
Affiliation  DR RMLIMS 
Address  Dr RMLIMS ROOM No 601 Vibhuti khand Gomti nagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  9933208279  
Fax    
Email  nidhivarma2424@gmail.com  
 
Source of Monetary or Material Support  
Dr RMLIMS Lucknow Uttar Pradesh 
 
Primary Sponsor  
Name  Dr Manoj Kumar Giri 
Address  Faculty apartment Dr.RMLIMS campus Vibhuti Khand Gomti Nagar Lucknow 
Type of Sponsor  Other [Individual] 
 
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 Manoj Kumar Giri  Dr. Ram Manohar Lohia Institute of Medical Sciences  Neurosurgery ot 2nd floor Dr.RMLIMS
Lucknow
UTTAR PRADESH 
9044479649

drmanoj.giri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR RMLIMS LUCKNOW  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system, (2) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Magnesium sulphate  Administration of magnesium sulphate infusion in craniotomy patients after induction till dura closure 
Intervention  nil  In control group patients undergoing craniotomy will not be given MgSO4 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  ASA Grade 1 and 2 patients
Elective craniotomies (both supratentorial and posterior fossa surgeries)
GCS 15
 
 
ExclusionCriteria 
Details  ASA Grade III and IV
Pregnant female
Patients with neuromuscular renal cardiovascular 0r hepatic insufficiency
BMI<18.5 or > 24.9kg/m2
Allergy to the study drugs
Those on treatment with calcium channel blockers or magnesium
Patients who will be shifted on ventilator post craniotomy
Anaesthesia time more than 5 hrs preventing excessive infusion of MgSO4
Any other mental or physical illness rendering them incapable of answering pain score
Patient on any previous chronic pain medications like gabapentin or pregabalin
Trauma and emergency craniotomies  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Effect of magnesium sulphate on reduction in post operative rescue analgesic requirement and post operative pain in the study group  start magnesium sulphate after induction till closure of dura.Post operative pain will be assessed at 1st hr 2nd hr 4th hr 6th hr 8th hr 12th hr 16th hr 20th hr and 24 hrs  
 
Secondary Outcome  
Outcome  TimePoints 
Effect of MgSO4 on reduction of intraop dose of Propofol and Vecuronium during surgery  start magnesium sulphate after induction till closure of dura 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   15/03/2023 
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 Yet Recruiting 
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)?  

Response - NO
Brief Summary   AIM : This study has to evaluate effect of MgSO4 on total anaesthetic requirement intraoperatively as well as post operative total analgesic requirement in craniotomy patients .
OBJECTIVE : Primary - Comparing total post operative rescue analgesic (tramadol) requirement in patients on MgSO4 infusion during craniotomy to that of patients not on MgSO4 infusion during craniotomy .
Secondary : 1. Comparing post operative VAS score in both the groups for 24 hours .
2. Comparing total dose of Propofol and Vecuronium required in the study and control group till the end of surgery .

 
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