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CTRI Number  CTRI/2023/06/054104 [Registered on: 19/06/2023] Trial Registered Prospectively
Last Modified On: 15/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To compare Effectiveness of two drugs Esmolol and Lignocaine for decreasing the Pressor Response during artificial tube insertion in respiratory tube under General Anaesthesia. 
Scientific Title of Study   Comparison of Intravenous Esmolol Versus Dexmedetomidine For Attenuation Of Hemodynamic Responses During Laryngoscopy And Endotracheal Intubation In Adult Patients Undergoing Laproscopic Surgeries: A Prospective Randomized, Interventional Study in deparment of anaesthesia, S.M.S. Medical Collage, Jaipur. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shriphal Meena 
Designation  Senior Proffesor  
Affiliation  Sawai Man Singh Medical Collage & Hospital Jaipur 
Address  Department of Anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR

Jaipur
RAJASTHAN
302004
India 
Phone  9928350391  
Fax    
Email  dr.shriphal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shriphal Meena 
Designation  Senior Proffesor  
Affiliation  Sawai Man Singh Medical Collage & Hospital Jaipur 
Address  Department of Anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR

Jaipur
RAJASTHAN
302004
India 
Phone  9928350391  
Fax    
Email  dr.shriphal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sovit Kumar Jain 
Designation  Resident Doctor 
Affiliation  Sawai Man Singh Medical Collage & Hospital Jaipur 
Address  Department of Anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR.
Department of Anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR
Jaipur
RAJASTHAN
302004
India 
Phone  09802811096  
Fax    
Email  drsovitjain@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology SMS MEDICAL COLLEGE AND JAIPUR RAJASTHAN 
 
Primary Sponsor  
Name  Dr Shriphal Meena 
Address  Department of Anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR 
Type of Sponsor  Other [] 
 
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 Shriphal Meena  SMS MEDICAL COLLEGE AND HOSPITAL  Department of Anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR
Jaipur
RAJASTHAN 		 09928350391

dr.shriphal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  In this study we give drugs in healthy individuals which comes in Operation Theatre for laproscopic surgies to attenuate the hemodynamic responses of Direct Laryngoscopy and Endotracheal Intubation. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Attenuating the pressure Response to Laryngoscopy and Endotracheal intubation under General Anaesthesia.  Attenuating the pressure Response to Laryngoscopy and Endotracheal Intubation by use of injection Dexmedetomidine 0.5 microgm per kg versus injection Esmolol 0.5mg per kg during laproscopic surgeries upto 10 minutes after intubation under General Anaesthesia. 
Comparator Agent  Effect of injection Dexedetomidine 0.5 mg per kg intravenous dose   Effectiveness of injection Dexedetomidine 0.5 mg per kg intravenous dose for Attenuating the Pressor Response to Laryngoscopy and Endotracheal Intubation under General Anaesthesia  
Comparator Agent  Effect of injection Esmolol 0.5 mg per kg intravenous dose.  Effectiveness of injection Esmolol 0.5 mg per kg intravenous dose for Attenuating the Pressor Response to Laryngoscopy and Endotracheal Intubation under General Anaesthesia.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients belonging to American Society of Anaesthesiologist (ASA) physical status grade I and II. 2. Patients willing to give written informed consent. 3. Patients of either sex.4. Age Groups 18 to 60 years. 5. Weighing 40 to 70 kg. 
 
ExclusionCriteria 
Details  1. Patients having history of convulsion and history of allergy to anaesthestic agents used in study.
2. Patients with anticipated difficult intubation i.e Mallampati class 3 or more,restricted neck movement or restricted mouth opening.
3. Pregnant patients and lactating mothers. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the difference in changes in Heart rate from baseline to different time intervals in the two groups.  0,1,3,5,10 minutes after Intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the difference in changes in Heamodynamic Responses (SBP, DBP, MAP) from baseline to different time intervals in the two groups.  0,1,3,5,10 minutes after Intubation. 
 
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   N/A 
Date of First Enrollment (India)   14/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/08/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
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 - Informed Consent Form

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to email ID - drsovitjain@gmail.com

  6. For how long will this data be available start date provided 07-08-2023 and end date provided 07-08-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   In this study we will compare effectiveness of intravenous Dexmedetomidine (0.5microgram/kg) and Esmolol (0.5mg/kg) for attenuating the hemodynamic responses to laryngoscopy and endotracheal intubation in adult patients undergoing laparoscopic surgeries under general anesthesia procedures. 
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