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CTRI Number  CTRI/2021/08/035814 [Registered on: 19/08/2021] Trial Registered Prospectively
Last Modified On: 18/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To find out which of the drugs; Magnesium sulphate or Clonidine given through nasal route, provide optimal conditions during administration of general anesthesia. 
Scientific Title of Study   A Comparative study of Magnesium Sulphate and Clonidine nebulizations in attenuation of pressor response to direct laryngoscopy, intubation and post operative sore throat. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Smitha K S 
Designation  Assistant professor 
Affiliation  Bangalore Medical College and Research Institute  
Address  Department of Anesthesia Bangalore Medical College and Research Institute Fort K R Road Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9886935506  
Fax    
Email  smi9685@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Smitha K S 
Designation  Assistant professor 
Affiliation  Bangalore Medical College and Research Institute  
Address  Department of Anesthesia Bangalore Medical College and Research Institute Fort K R Road Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9886935506  
Fax    
Email  smi9685@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Smitha K S 
Designation  Assistant professor 
Affiliation  Bangalore Medical College and Research Institute  
Address  Department of Anesthesia Bangalore Medical College and Research Institute Fort K R Road Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9886935506  
Fax    
Email  smi9685@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute 
 
Primary Sponsor  
Name  Dr Smitha K S 
Address  Bangalore Medical College and Research Institute Fort K R Road Bangalore 560002 Karnataka India  
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 Smitha K S  Bangalore Medical College and Research Institute  Department of Anaesthesia Victoria Hospital Fort K R Road Bangalore 560002 India
Bangalore
KARNATAKA 		 9886935506

smi9685@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Medical College and Research Institute  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  Clonidine nebulisation  Patients will be nebulized with Clonidine 150mcg (1ml) diluted to 3ml with normal saline. Total volume being 3ml. 
Intervention  Magnesium Sulphate nebulisation  Patients will be nebulized with Magnesium Sulphate 50%, 500mg(1ml) diluted to 3ml with normal saline prior to intubation. Total volume being 3ml. 
Comparator Agent  Placebo  Patients will be nebulised with 3 ml of normal saline before intubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients who are willing to give written/ informed consent.
2)Patients undergoing elective surgeries under general anaesthesia.
3)Patients belonging to ASA I and II.
4)Patients aged between 18-60 years of age of both genders.
 
 
ExclusionCriteria 
Details  1)Patients not willing to give written/informed consent.
2)Patients prone to allergies.
3)Patients with prior history of sore throat.
4) Patients with neurological pathologies
5) Patients with cardiovascular instabilities
 
 
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 
To evaluate and compare the effect of Magnesium sulphate and Clonidine nebulizations on the haemodynamic response upon laryngoscopy and tracheal intubation.  4- 5 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the effect of Magnesium sulphate and clonidine nebulizations on postoperative sore throat.  24 -36 hours after intubation 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   25/08/2021 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [smi9685@gmail.com].

  6. For how long will this data be available start date provided 01-09-2021 and end date provided 01-02-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   As the procedures of laryngoscopy and tracheal intubation during induction of general anesthesia cause increase in heart rate and blood pressure, the search for an ideal agent to attenuate the pressor response has been ongoing. Any drug given  intravenously for the same has other systemic deleterious effects. Hence, the nebulisation route,a safer and alternative route, will be evaluated is this study using two drugs exclusively which are known to attenuate the response. The two agents being Magnesium Sulphate and Clonidine. Also, their effect on the post operative sore throat will be evaluated. 
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