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CTRI Number  CTRI/2025/12/099730 [Registered on: 23/12/2025] Trial Registered Prospectively
Last Modified On: 22/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study of Magnesium Sulphate Injection for Pain Control After Gallbladder Surgery 
Scientific Title of Study   A prospective randomized controlled study to assess the Effect of Intravenous Injection of Magnesium Sulphate 30 mg per kg on Intraoperative End-Tidal Carbon Dioxide Level and Postoperative Pain in patients undergoing Laparoscopic Cholecystectomy 
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 Bharat Purohit  
Designation  Resident Anesthesiology 
Affiliation  Pacific Medical College and Hospital 
Address  Department of Anesthesiology and critical care, Third floor Pacific Medical College and Hospital, Bilo Ka Bedla Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  8928242489  
Fax    
Email  purohitbharat124@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijay Kumar 
Designation  Professor 
Affiliation  Pacific Medical College and Hospital 
Address  Department of Anesthesiology and critical care, Third floor Pacific Medical College and Hospital, Bilo Ka Bedla Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9413893218  
Fax    
Email  Chaharvijay03@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vijay Kumar 
Designation  Professor 
Affiliation  Pacific Medical College and Hospital 
Address  Department of Anesthesiology and critical care, Third floor Pacific Medical College and Hospital, Bilo Ka Bedla Udaipur


RAJASTHAN
313001
India 
Phone  9413893218  
Fax    
Email  Chaharvijay03@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology and Critical Care, Third floor Main Campus, Pacific Medical College and Hospital, Bilo Ka Bedla, Udaipur Rajasthan Pincode 313001 
 
Primary Sponsor  
Name  Pacific Medical College and Hospital Udaipur 
Address  Department of Anesthesiology and Critical Care, Third floor Pacific Medical College and Hospital, Bilo Ka Bedla Udaipur Rajasthan Pincode 303001 
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 Bharat Purohit  Pacific Medical College and Hospital  Department of Anesthesiology and critical care, Third floor Pacific Medical College and Hospital, Bilo Ka Bedla Udaipur Rajasthan Pincode 313001
Udaipur
RAJASTHAN 		 8928242489

purohitbharat124@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Pacific Medical College and Hospital Udaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R52||Pain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Magnesium Sulphate 30 mg per kg intravenous  Given preoperatively before induction for over 10 minutes 
Comparator Agent  Normal saline intravenous  Equal volume given over 10 minutes before induction 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients of both genders aged between 18 to 65 years
Patients Scheduled for elective laparoscopic cholecystectomy under general anesthesia
American Society of Anesthesiologists physical status I or II

Patients who provide written informed consent
 
 
ExclusionCriteria 
Details  Age 18 and 65 years
Patient not giving written consent for study participation.
ASA physical status III and IV
Known allergy or hypersensitivity to magnesium sulfate
History of renal impairment or dysfunction eg creatinine clearance less than 60 ml per min
Patients with cardiac conduction abnormalities eg heart block
Patients on calcium channel blockers or magnesium-containing medications
Severe hepatic dysfunction 
 
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 assess the changes in intraoperative EtCO2 following administration of intravenous
magnesium sulphate.
To evaluate the effect of magnesium sulphate on postoperative pain scores 		 To assess the changes in intraoperative EtCO2 following administration of intravenous
Magnesium sulphate at 1min, 5min, 10min, 15min, 20min, 25min, 30min, 60min
To evaluate the effect of magnesium sulphate on postoperative pain scores at 1min, 5min, 10min, 15min, 20min, 25min, 30min, 60min 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of intravenous magnesium sulphate on postoperative pain scores using the Visual Analog Scale (VAS) at 1,4,12 and 24 hours postoperatively.
To observe any intraoperative hemodynamic changes (heart rate, mean arterial pressure) associated with magnesium sulphate administration.
To record any adverse effects or complications related to magnesium sulphate administration
 		 To assess the effect of intravenous magnesium sulphate on postoperative pain scores using the Visual Analog Scale (VAS) at 1,4,12 and 24 hours postoperatively.
To observe any intraoperative hemodynamic changes (heart rate, mean arterial pressure) associated with magnesium sulphate administration.
To record any adverse effects or complications related to magnesium sulphate administration at baseline 1min 5min 10min 15min 20min 25min 30min

 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   10/01/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Laparoscopic cholecystectomy often causes increased EtCO2 due to pneumoperitoneum, leading to physiological stress and higher anaesthetic requirements. Magnesium sulphate, through its NMDA-antagonist and analgesic properties, has been shown to reduce sympathetic response, stabilise haemodynamics, and improve postoperative pain control. Although magnesium is widely used as an adjuvant in anaesthesia, its effect on intraoperative EtCO2 levels during laparoscopic surgery has not been clearly established. Hence, further evaluation is justified. 
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