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CTRI Number  CTRI/2025/09/094076 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Efficacy and safety of two different doses of magnesium sulphate as adjuvant in spinal anaesthesia 
Scientific Title of Study   Efficacy of two different doses of magnesium sulphate as adjuvant to 0.5percent hyperbaric bupivacaine in spinal anaesthesia for lower limb surgeries- A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr P Bhavya Malika 
Designation  post graduate trainee 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, Kalinga Institute of Medical Sciences, KIIT deemed to be university, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  7993061059  
Fax    
Email  pbhavyamalika@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Pradhan 
Designation  Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, Kalinga Institute of Medical Sciences, KIIT deemed to be university, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9437191002  
Fax    
Email  amitpdear@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sapna Das 
Designation  Assistant Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, Kalinga Institute of Medical Sciences, KIIT deemed to be university, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9078826164  
Fax    
Email  dr.sapnadas88@gmail.com  
 
Source of Monetary or Material Support  
Kalinga Institute Of Medical Sciences, Bhubaneswar, Khordha, Odisha, PIN 751024 
 
Primary Sponsor  
Name  P Bhavya Malika 
Address  Department of Anaesthesiology, Kalinga Institute of Medical Sciences, KIIT Deemed to be university, Bhubaneswar PIN: 751024 
Type of Sponsor  Other [[Self]] 
 
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 P Bhavya Malika  Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences  Department of Anaesthesia, Kalinga Institute of Medical Sciences, Bhubaneswar, PIN: 751024
Khordha
ORISSA 		 7993061059

pbhavyamalika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kalinga Institute of Medical Sciences, KIIT deemed to be University, Bhubaneswar-751024  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 
Intervention  Addition of magnesium sulphate as adjuvant to 0.5 percent hyperbaric bupivacaine in spinal anaesthesia for lower limb surgeries  Group A: will receive 15mg(3ml) of 0.5 percent hyperbaric bupivacaine + 100mg(0.2ml) of 50 percent magnesium sulphate + 0.1ml of saline intrathecally.  
Intervention  Addition of magnesium sulphate as adjuvant to 0.5 percent hyperbaric bupivacaine in spinal anaesthesia for lower limb surgeries   Group B: will receive 15mg(3ml) of 0.5 percent hyperbaric bupivacaine + 150mg(0.3ml) of 50 percent magnesium sulphate.  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)ASA physical status 1 or 2
2)Undergoing elective lower limb surgery under spinal anaesthesia
3)Height 140 to 180cms
4)Weight 40 to 80kgs 
 
ExclusionCriteria 
Details  1)Known allergy to study drugs
2)Contraindications to spinal anaesthesia
3)Significant cardiovascular/renal/hepatic/neuromuscular disorders
4)Psychological disorder 
 
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 
Time of requirement of first dose of rescue analgesia(min)  upto 12 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Time of onset of sensory block(min)   
Time of onset of motor block(min)   
Duration of sensory block(min)   
Duration of motor block(min)   
Hemodynamic changes- HR, SBP, DBP, SpO2 every 5 minutes for first 30 minutes and then every 15 minutes till the end of surgery   
Post operative VAS score at 1,2,4,6,12 hours  1,2,4,6,12hours 
Incidence of side effects such as post operative nausea and vomiting(PONV), shivering upto 24hours    
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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   Phase 2 
Date of First Enrollment (India)   01/09/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   Magnesium sulphate acts as a N-methyl-D-aspartate (NMDA) receptor antagonist, modulating central sensitization and enhancing the duration and quality of spinal anaesthesia.
Although magnesium has no direct antinociceptive effects, it inhibits calcium ions from entering cells by blocking NMDA receptors resulting in analgesic effect.
Studies had demonstrated that adding 50mg or 100mg of magnesium sulphate to bupivacaine prolongs the onset and duration of sensory and motor blocks, reduces postoperative analgesic consumption and maintains hemodynamic stability without significant adverse effects.
We expect an increase in the duration of postoperative analgesia without any side effects on increasing the dose of magnesium sulphate as an adjuvant in spinal anaesthesia.
Primary Objective: To compare the efficacy of 100mg and 150mg magnesium sulphate as adjuvant to 0.5 percent hyperbaric bupivacaine in spinal anaesthesia for lower limb surgeries.
Secondary Objective: To ensure patient safety and observe for adverse effects if any.
 
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