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CTRI Number  CTRI/2021/10/037063 [Registered on: 04/10/2021] Trial Registered Prospectively
Last Modified On: 02/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between Clonidine and Lignocaine in response to laryngoscopy and endotracheal intubation 
Scientific Title of Study   Comparative study between intravenous Clonidine and intravenous Lignocaine in the attenuation of pressor responses to laryngoscopy and endotracheal intubation. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shahbaz Haroon 
Designation  Junior Resident  
Affiliation  Dr. D. Y. Patil Medical College, Hospital & Research Centre 
Address  Dr. D.Y PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Sant Tukaram Nagar Pimpri Pune 411018

Pune
MAHARASHTRA
411018
India 
Phone  8105236310  
Fax    
Email  shahbaz.haroon92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Smita Joshi 
Designation  Professor and HOD 
Affiliation  Dr. D. Y. Patil Medical College, Hospital & Research Centre 
Address  Department of Anaesthesia Dr. D.Y PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Sant Tukaram Nagar Pimpri Pune 411018

Pune
MAHARASHTRA
411018
India 
Phone  9822053792  
Fax    
Email  smitajoshi6@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shahbaz Haroon 
Designation  Junior Resident  
Affiliation  Dr. D. Y. Patil Medical College, Hospital & Research Centre 
Address  Dr. D.Y PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Sant Tukaram Nagar Pimpri Pune 411018

Pune
MAHARASHTRA
411018
India 
Phone  8105236310  
Fax    
Email  shahbaz.haroon92@gmail.com  
 
Source of Monetary or Material Support  
Central pharmacy;Dr.DY Patil Medical College Hospital and Research centre.  
 
Primary Sponsor  
Name  Dr Shahbaz Haroon  
Address  Dr. D.Y PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Sant Tukaram Nagar Pimpri Pune 
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 Shahbaz Haroon  Hightech OT complex, 5th floor, Hightech building  Dr. D.Y. Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri
Pune
MAHARASHTRA 		 8105236310

shahbaz.haroon92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Sub Committee Dr. D.Y. Patil Medical College Hospital and Research Centre  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  Intravenous Clonidine   Intravenous Clonidine 2mcg/kg over 10 min in attenuation of pressor responses in laryngoscopy and endotracheal intubation  
Comparator Agent  Intravenous Lignocaine  Intravenous Lignocaine 1.5mg/kg over 10 min in attenuation of pressor responses in laryngoscopy and endotracheal intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age between 18-60 yr of either sex.
2. ASA grade I and grade II.
3. Patients posted for elective surgeries under general anesthesia requiring intubation.
4. Hemodynamically stable patients having all routine investigations within normal limits.
5. Patients who give written informed consent and are willing to be part of the study. 
 
ExclusionCriteria 
Details  1. Patients refusal.
2. Patients with ASA physical status III and more.
3. Patients with any pre-existing cardiovascular disease.
4. Patients with h/o allergy to test drugs.
5. Patients posted for emergency surgeries.
6. Patients with difficult airway.
7. Patients with neurological disorders and muscle diseases. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To observe the attenuation of pressor responses to laryngoscopy and endotracheal intubation with intravenous clonidine  PRE INTUBATION, SCOPY 0 MINS, EVERY 5 MINUTES, UPTO 2 HOURS INTRA-OP, POST OP VAS, SEDATION 
 
Secondary Outcome  
Outcome  TimePoints 
To study the side effects of Clonidine and Lignocaine, if any and Ramsay sedation scale   Ramsay sedation scale: immediately, 1 hour, 6 hour and 12 hour after surgery 
 
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)   30/10/2021 
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="1"
Months="6"
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 (Others) - 

  6. For how long will this data be available start date provided 06-08-2023 and end date provided 06-08-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   It is a randomized, prospective, comparative, double blinded, observational study where in intravenous lignocaine and intravenous clonidine are compared for the attenuation of hemodynamic pressor responses during laryngoscopy and endotracheal intubation before any surgical procedures in the operation theatre. 
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