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CTRI Number  CTRI/2025/09/094426 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 24/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   In this trial I will compare nebulization with magnesium sulphate versus dexmedetomidine for controlling blood pressure spikes during securing airway in pregnant mothers with high blood pressure undergoing Caesarean section  
Scientific Title of Study   Comparison of preoperative magnesium sulphate versus dexmedetomidine nebulisation for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation in severe preeclampsia parturients undergoing caesarean section: A Randomised clinical 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  Dr Arvind Khare  
Designation  Senior Professor and Head of Department  
Affiliation  Jawahar lal Nehru Medical College  
Address  Head of Department chamber, New OT block 1st floor, Jawahar lal Nehru Medical College, Ajmer

Ajmer
RAJASTHAN
305001
India 
Phone  9414306114  
Fax    
Email  arvindkhare68@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arvind Khare  
Designation  Senior Professor and Head of Department  
Affiliation  Jawahar lal Nehru Medical College  
Address  Head of Department chamber, New OT block 1st floor, Jawahar lal Nehru Medical College, Ajmer

Ajmer
RAJASTHAN
305001
India 
Phone  9414306114  
Fax    
Email  arvindkhare68@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arvind Khare  
Designation  Senior Professor and Head of Department  
Affiliation  Jawahar lal Nehru Medical College  
Address  Head of Department chamber, New OT block 1st floor, Jawahar lal Nehru Medical College, Ajmer

Ajmer
RAJASTHAN
305001
India 
Phone  9414306114  
Fax    
Email  arvindkhare68@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology New OT 1st floor,Jawahar Lal Nehru medical college and hospital,ajmer.305001 
 
Primary Sponsor  
Name  JLN Medical College  
Address  kalabagh,Ajmer,Rajasthan, 305001. 
Type of Sponsor  Government 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 Megha Agarwal   Janana hospital, Ajmer   OT Block, 1st floor, Janana hospital
Ajmer
RAJASTHAN 		 9462011843

meghaagarwal261@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawahar lal Nehru Medical College, Ajmer   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O141||Severe pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group D- Dexmedetomidine   With due approval from institutional ethical committee a randomised clinical study will be conducted on severe preeclampsia parturients undergoing caesarean section under general anaesthesia nebulization with Inj Dexmedetomidine 1microgram/kg diluted upto 5ml with normal saline will be done before induction for 10min in sitting position. We will observe for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation for first 10 minutes. A Written informed consent will be taken in prior to procedure.  
Comparator Agent  Group M - Magnesium Sulphate   With due approval from institutional ethical committee a randomised clinical study will be conducted on severe preeclampsia parturients undergoing caesarean section under general anaesthesia nebulization with Inj Magnesium Sulphate 40mg/kg diluted upto 5ml with normal saline will be done before induction for 10min in sitting position. We will observe for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation for first 10 minutes. A Written informed consent will be taken in prior to procedure.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Parturients with severe preeclampsia undergoing caesarean section under general anaesthesia with asa physical status 1 and 2 
 
ExclusionCriteria 
Details  1)ASA status more than 2
2) Mallampati grade more than 2
3) Allergic to study drug
4) Anticipated difficult intubation
5) Requiring more than 2 attempts at intubation
6)BMI 40 or more than 40kg/m2
7) Comorbidities
8) Emergency Caesarean section
9) Consent not given to participate in clinical study  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess changes in hemodynamic parameters like heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure   Assessed before nebulization, after completion of nebulization, at the time of laryngoscopy and intubation, at 1 min, 2min, 3min, 4min, 6min, 8min, 10min after intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
Cough at time of extubation  At the time of extubation  
Post operative sore throat   At time of extubation, at 6hr post extubation and at 12hr post extubation  
Side effects of drug   
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   08/09/2025 
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="1"
Months="0"
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   Laryngoscopy and endotracheal intubation cause significant sympathetic stimulation, resulting in tachycardia and hypertension, responses that are exaggerated and potentially hazardous in severe preeclampsia due to already elevated vascular resistance. This randomised clinical study aims to compare the efficacy of preoperative nebulization with inj magnesium sulphate 40mg/kg versus preoperative nebulization with inj dexmedetomidine 1 microgram/kg in attenuating the pressor response during induction and intubation in preeclamptic parturients scheduled for caesarean section. Patient will be divided in two groups, Group D receiving inj dexmedetomidine nebulization and Group M receiving inj magnesium Sulphate nebulization. Patient is assessed for changes in heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure in peri-intubation period. This study will help us to compare efficacy of both of these agents in attenuating the hemodynamic response. 
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