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CTRI Number  CTRI/2025/09/094930 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 12/09/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing two medicines- Injection Dexmedetomidine and Injection Magnesium Sulphate for observing the blood pressure changes in high blood pressure patients during micro surgery. 
Scientific Title of Study   COMPARING DEXMEDETOMIDINE TO MAGNESIUM SULPHATE ON HEMODYNAMIC RESPONSE IN HYPERTENSIVE PATIENTS IN LAPAROSCOPIC SURGERY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Surajit Goswami 
Designation  DNB Post Graduate Trainee 
Affiliation  ESI PGIMSR & Hospital, Manicktala 
Address  Main OT Complex, 3rd floor, Department of Anaesthesiology, ESI PGIMSR & Hospital, Manicktala 54, Bagmari Road, Kolkata

Kolkata
WEST BENGAL
700054
India 
Phone  8420045559  
Fax    
Email  surajitgoswami621@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tanunita Mondal 
Designation  Senior Consultant, Anaesthesiology 
Affiliation  ESI PGIMSR & Hospital, Manicktala, 
Address  Main OT Complex, 3rd floor, Department of Anaesthesiology, ESI PGIMSR & Hospital Manicktala, 54, Bagmari road, Kolkata-700054

Kolkata
WEST BENGAL
700054
India 
Phone  8335952433  
Fax    
Email  tanunita@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Surajit Goswami 
Designation  Secondary DNB postgraduate trainee 
Affiliation  ESI PGIMSR and HOSPITAL, Manicktala 
Address  Main OT Complex, 3rd floor, Department of Anaesthesiology, ESI PGIMSR & Hospital Manicktala, 54, Bagmari road, Kolkata-700054

Kolkata
WEST BENGAL
700054
India 
Phone  8420045559  
Fax    
Email  surajitgoswami621@gmail.com  
 
Source of Monetary or Material Support  
ESI Hospital and PGIMSR, Manicktala, Kolkata 54 
 
Primary Sponsor  
Name  ESI PGIMSR Hospital Manicktala 
Address  Main OT Complex, 3rd floor, Department of Anaesthesiology, ESI PGIMSR & Hospital Manicktala, 54, Bagmari road, Kolkata-700054 
Type of Sponsor  Research institution and hospital 
 
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 Surajit Goswami  ESI PGIMSR & Hospital, Manicktala  Main OT Complex, 3rd floor, Department of Anaesthesiology, ESI PGIMSR & Hospital Manicktala, 54, Bagmari road, Kolkata-700054
Kolkata
WEST BENGAL 		 8420045559

surajitgoswami621@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ESI PGIMSR & Hospital, Manicktala  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  Dexmedetomidine  This group of patients will receive an IV loading dose of Dexmedetomidine at 1 microgram per kg over 10 minutes, followed by maintenance infusion at 0.5 microgram per kg per hour till completion of pneumoperitoneum.  
Intervention  Drug Intervention  Two different group of patients will receive two different drugs. 
Comparator Agent  Magnesium Sulphate   This group of patients will receive an IV loading dose of Magnesium Sulphate at 30 milligram per kg over 10 minutes, followed by maintenance infusion at 10 milligram per kg per hour till completion of pneumoperitoneum.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diagnosed hypertensive patients on regular treatment

Age 25-65 years

Either sex

ASA class II

Scheduled for elective laparoscopic procedure

Surgery duration minimum 40 minutes 
 
ExclusionCriteria 
Details  1. Incidence of bradycardia HR less than 50 bpm
2. Incidence of hypotension MAP less than 60 mmHg
3. Requirement for rescue medications
4. Intraoperative anesthetic requirements
5. Time to extubation
6. Post-operative sedation scores
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Changes in systolic blood pressure (SBP) at predefined time intervals
2. Changes in diastolic blood pressure (DBP) at predefined time intervals
3. Changes in mean arterial pressure (MAP) at predefined time intervals
4. Changes in heart rate (HR) at predefined time intervals 		 baseline, post-intubation, post-pneumoperitoneum creation,
every 15 minutes during pneumoperitoneum, end of pneumoperitoneum,
post-extubation 
 
Secondary Outcome  
Outcome  TimePoints 
1. Incidence of bradycardia
2. Incidence of hypotension
3. Requirement for rescue medications
4. Intraoperative anesthetic requirements
5. Time to extubation
6. Post-operative sedation scores
 		 Incidence of Bradycardia & Hypotension will be recorded every 10-15 minutes during surgery. Requirement for rescue medications during surgery, as per need.
Intraoperative anaesthetic requirements will be noted, as & when required.
Time of extubation will be recorded.
Post-operative sedation scores will assesses at 4th hour, 8th hour & 12th hour from end of surgery.  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/10/2025 
Date of Study Completion (India) 23/07/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 23/07/2026 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   Hypertensive patients commonly exhibit exaggerated cardiovascular responses to perioperative stressors such as laryngoscopy, intubation, pneumoperitoneum creation and extubation. Laparoscopic surgery further provokes sympathetic activation through increased intra-abdominal pressure and carbon dioxide insufflation, potentially precipitating perioperative ischemia or hemodynamic instability in patients with chronic hypertension. This present prospective interventional study will evaluate which of the two drugs between Dexmedetomidine and Magnesium Sulphate is associated with better hemodynamic control and perioperative stability in hypertensive patients undergoing laparoscopic procedures. 
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