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CTRI Number  CTRI/2026/03/105185 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 28/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study in Patients Undergoing Keyhole (Laparoscopic) Surgery to Compare Magnesium Alone Versus Magnesium with Vitamin C for Reducing Pain After Surgery. 
Scientific Title of Study   Evaluation of the efficacy of magnesium sulphate vs magnesium sulphate with vitamin c for post operative pain in laproscopic surgeries under general anaesthesia : a randomised clinical 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 Arpita Sajjanar 
Designation  Post Graduate Resident  
Affiliation  BLDE SHRI B M PATIL MEDICAL COLLEGE ( DEEMED TO BE UNIVERSITY)  
Address  3rd floor OT Complex , Department of Anaesthesiology

Bijapur
KARNATAKA
586103
India 
Phone  8296130685  
Fax    
Email  sajjanararpita@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Nirmala Devi kagalkar 
Designation  Associate Professor 
Affiliation  BLDE SHRI B M PATIL MEDICAL COLLEGE ( DEEMED TO BE UNIVERSITY)  
Address  3rd floor OT Complex , Department of Anaesthesiology

Bijapur
KARNATAKA
586103
India 
Phone  8217618954  
Fax    
Email  nirmalakagalkar77@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Arpita Sajjanar 
Designation  Post Graduate Resident  
Affiliation  BLDE SHRI B M PATIL MEDICAL COLLEGE ( DEEMED TO BE UNIVERSITY)  
Address  3rd floor OT Complex , Department Of Anaesthesiology

Bijapur
KARNATAKA
586103
India 
Phone  8296130685  
Fax    
Email  sajjanararpita@gmail.com   
 
Source of Monetary or Material Support  
SHRI B M PATIL MEDICAL COLLEGE 3rd floor OT Complex , Department Of Anaesthesiology,bangaramma sajjan campus 
 
Primary Sponsor  
Name  nil 
Address  nil 
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 Arpita  BLDE,SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE  3 rd floor ot complex,department of anesthesia,bangaramma sajjan campus
Bijapur
KARNATAKA 		 8296130685

sajjanararpita@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: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group M(Magnesium Sulfate)  Received 40 mg/kg of magnesium sulfate diluted in 40 ml saline. A bolus was infused over 20 minutes T 1 before anesthesia, followed by continuous infusion (10 mg/kg/h) T 2 during surgery. total time :_till 24 hrs post surgery 
Comparator Agent  Group MV(Magnesium + Vitamin C)  T1 BEFORE INDUCTION Received a combined bolus of magnesium sulfate (40 mg/kg) and vitamin C (50 mg/kg) before anesthesia, followed by a magnesium-only infusion T2 during surgery. total time : till 24 hrs post surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1Adults of either sex age between 18 to 65 years
2ASAgradeI andII
3Duration of surgery expected to exceed 60 minutes.
4BMIbetween18.5 and 30 kg/m2 
 
ExclusionCriteria 
Details  1 RenalImpairment
2MyastheniaGravis
3HeartBlock or Severe Cardiac Dysfunction
4Hypotension
5Hypermagnesemia
6KnownAllergyorHypersensitivity to Magnesium
7Concurrent Use of Calcium Channel Blockers or CNS Depressants 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
.Postoperative pain intensity is measured using the visual analogue
score (VAS). 		 .Postoperative pain intensity is measured using the visual analogue score (VAS).
Baseline,2 nd ,4th,6th,12th,24th hour post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1 Hemodynamic monitoring-heart rate , systolic blood pressure , diastolic blood pressure , mean
arterial pressure , SpO2%
2. Time for first rescue analgesia.
3 .To know the incidence of post operative nausea vomiting 		 POST OPERATIVE  
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   11/03/2026 
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="8"
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 randomised controlled trial evaluates the effect of magnesium sulfate with and without vitamin c on postoperative pain following laproscopic surgeries under general anesthesia.the primary objective is to access postoperative pain intensity using the visual analogue scale .secondary outcomes include hemodynamic parameters,time to first rescue analgesia,and the incidence of postoperative nausea and vomiting. 
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