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CTRI Number  CTRI/2025/04/085338 [Registered on: 22/04/2025] Trial Registered Prospectively
Last Modified On: 05/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Two Medications for Numbing the Scalp During Brain Surgery: Effects on Blood Pressure, Heart Rate, and Pain After Surgery 
Scientific Title of Study   Comparative Study of Magnesium Sulphate Vs Dexmedetomidine as Adjuvants to Bupivacaine in Scalp Nerve Block: Effects on Intraoperative Hemodynamic Parameters and Postoperative Pain for Patients Undergoing Supratentorial Brain Tumour Craniotomy (A Prospective Randomized Comparative Study) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swati Gupta 
Designation  Senior Resident 
Affiliation  Mahatma Gandhi Medical College & Hospital 
Address  Okay plus venus, Jagatpura, Jaipur
Sitapura, Ricco industrial area, Jaipur
Jaipur
RAJASTHAN
302022
India 
Phone  9621103819  
Fax    
Email  gupta.swati0922@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sunita Sharma 
Designation  Professor and Head of Department 
Affiliation  Mahatma Gandhi Medical College & Hospital 
Address  Department of Neuroanesthesia Mahatma Gandhi Medical College & Hospital, Jaipur
Sitapura, Ricco industrial area, Jaipur
Jaipur
RAJASTHAN
302022
India 
Phone  7597053927  
Fax    
Email  drsunitakhs@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Swati Gupta 
Designation  Senior Resident 
Affiliation  Mahatma Gandhi Medical College & Hospital 
Address  Okay Plus Venus, Jagatpura, Jaipur
Sitapura, Ricco industrial area, Jaipur
Jaipur
RAJASTHAN
302022
India 
Phone  9621103819  
Fax    
Email  gupta.swati0922@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College & Hospital Sitapura Industrial Area, Jaipur Rajasthan, India Pin Code: 302022 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College Hospital 
Address  RIICO industrial area, Sitapura, Tonk road, Jaipur Rajasthan, India Pin Code: 302022 
Type of Sponsor  Private 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 Swati Gupta  Mahatma Gandhi Medical College & Hospital  Neurosurgery OT, Department of Neuroanesthesia, 4th floor, SRCC building, Jaipur RAJASTHAN
Jaipur
RAJASTHAN 		 9621103819

gupta.swati0922@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  bupivacaine magnesium sulphate dexmedetomidine  scalp block with 0.25%bupivacaine (28ml) + normal saline (2ml) with general anaesthesia scalp block with 0.25%bupivacaine (28ml) + normal saline (1.5ml) + dexmedetomidine (0.5ml/ 50 mcg) with general anaesthesia scalp block with 0.25%bupivacaine (28ml) + normal saline (1ml) + magnesium sulphate (1ml of 50%) with general anaesthesia 
Intervention  scalp nerve block  To be given at 5 points. 1. supraorbital 2.supratrochlear 3.zygomaticotemporal 4. greater occipital 5. lesser occipital to block the nerves supplying the scalp 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient fulfilling criteria ASA Classes I/ II
2. Patient aged 18-65 years of both sexes.
3. Patients undergoing elective supratentorial craniotomy under general anaesthesia.
 
 
ExclusionCriteria 
Details  Patient with ASA CLASS III, IV & V
Refusal of patient
Patient with difficult surgical anatomy
Patient with previous craniotomy incision
Local infection at the site of injection
History of allergy to opioid or local anaesthesia
Inability to comprehend or participate in pain scoring system.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate and compare intraoperative hemodynamic parameters, including heart rate (HR), systolic blood pressure, diastolic blood pressure, and mean arterial pressure.
2. To measure and compare postoperative Visual Analogue Scale (VAS) scores.
3. To determine the time until the first request for rescue analgesia
 		 intraoperatively
postoperatively
 
 
Secondary Outcome  
Outcome  TimePoints 
• To observe and compare the need for supplemental analgesics during surgery.
• To analyze and compare serum cortisol levels.
• To quantify the total dose of analgesics required within 24 hours.
• To calculate the total intraoperative dose of Inj. Propofol.
• To calculate the total intraoperative dose of Inj. Fentanyl.
 		 intraoperatively
postoperatively 
 
Target Sample Size   Total Sample Size="177"
Sample Size from India="177" 
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)   22/04/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study compares Magnesium Sulphate vs. Dexmedetomidine as adjuvants to Bupivacaine in scalp nerve block for patients undergoing supratentorial brain tumor craniotomy. It evaluates intraoperative hemodynamic stability, postoperative pain relief, and opioid consumption. 177 patients are randomized into three groups receiving Bupivacaine alone, with Dexmedetomidine, or with Magnesium Sulphate. Hemodynamic parameters, pain scores (VAS), cortisol levels, and analgesic requirements are assessed. The goal is to determine which adjuvant optimizes pain control and recovery while reducing opioid use. The study aims to improve anesthesia strategies and postoperative outcomes for brain surgery patients.

 
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