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CTRI Number  CTRI/2023/06/053563 [Registered on: 05/06/2023] Trial Registered Prospectively
Last Modified On: 29/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparative Clinical Study Of Dexmedetomidine Vs Clonidine For Hemodynamic Stability 
Scientific Title of Study   Randomised Prospective Comparative Clinical Study Of Dexmedetomidine Vs Clonidine For Hemodynamic Stability During Laproscopic Surgeries In General Anaesthesia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ARTI YADAV 
Designation  JUNIOR RESIDENT 
Affiliation  Swami vivekanand subharti university  
Address  Department of Anaesthesiology & Critical Care, Subharti Medical College, Meerut 250005

Meerut
UTTAR PRADESH
Meerut 250005
India 
Phone  9456997264  
Fax    
Email  artiy573@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Salony Agarwal 
Designation  Professor 
Affiliation  Swami vivekanand subharti university  
Address  Subharti medical college ,Meerut
Subharti Medical College, Meerut u.p.
Meerut
UTTAR PRADESH
Meerut 250005
India 
Phone  9557038599  
Fax    
Email  Drsalonysumitagarwal@gmail.com  
 
Details of Contact Person
Public Query  
Name  ARTI YADAV 
Designation  JUNIOR RESIDENT 
Affiliation  Swami vivekanand subharti university  
Address  Department of Anaesthesiology & Critical Care, Subharti Medical College, Meerut 250005

Meerut
UTTAR PRADESH
Meerut 250005
India 
Phone  9456997264  
Fax    
Email  artiy573@gmail.com  
 
Source of Monetary or Material Support  
SUBHARTI MEDICAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  ARTI YADAV 
Address  Begum hazrat mahal girls hostel subharti medical college  
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 
ARTI YADAV  Subharti medical college meerut  Department of anaesthesiology and critical care ,Subharti University ,Subhartipuram ,Meerut UTTARPRADESH
Meerut
UTTAR PRADESH 		 9456997264

artiy573@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
UNIVESITY ETHICS COMMITTEE(MEDICAL),SWAMI VIVEKANAND UNIVERSITY  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  Clonidine is Alfa2 receptor agonist DOSE 1 microgram/kg iv infusion over 10 min 
Intervention  Dexmedetomidine  Dexmedetomidine is Alfa2 receptor agonist Dose 2microgram/kg iv infusion over 10 min  
Comparator Agent  Normal Saline   Control Group Normal Saline 100 ml NS with in 10 min  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA Physical status I and II 
 
ExclusionCriteria 
Details  1. Patient refusal
2. History of laryngeal or tracheal surgery or pathology.
3. History of Bronchial asthma,
4. History of smoking, alcohol addiction or drug abuse.
5. Patients with coexisting systemic illness, morbid obese patient, neurological or psychological disease, hepatic or renal dysfunction, endocrinal or metabolic disorder.
6. Patients with hypertensive heart disease or on antihypertensives, beta blockers or calcium channel blockers.
7. Patient with known hypersensitivity or drug allergies.
8. Age less than 18 or more than 60.
9. Basal heart rate less than 60 and patient with heart block or with conduction defect.
10. Active upper respiratory tract infections.
11. Patients with difficult airway MP grade III and IV.
12. Pregnant or lactating female


 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate and compare the intraoperative hemodynamic parameter with intravenous dexmedetomidine and intravenous clonidine as premedication during laproscopic surgeries under general anaesthesia.  vital monitoring was done at baseline ,1 min before premedication ,1 min after premedication,1 min before induction,1 min after induction,1 min before intubation ,1 min after intubation,2 min,4 min,6 min,8 min ,10 min ,1 min after CO2 insufflation,after 15 min,at 5 min time interval up to 90 min . 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate Side effects of intravenous dexmedetomidine and clonidine.  1 min after giving drugs,2min,4min,6min,8min 10 min at 5 min time interval up to 90 min . 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   10/06/2023 
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 Yet Recruiting 
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 - Informed Consent Form
    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 [artiy573@gmail.com].

  6. For how long will this data be available start date provided 15-03-2023 and end date provided 15-12-2026?
    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   This study is randomized ,controlled,parallel group,single centre trial comparing the hemodynamic stability of dexmedetomidine and clonidine during laproscopic surgery in general anesthesia.The study will be conducted over 18 months in 120 patients in subharati medical college,Meerut,UP ,India.The Primary Outcome measures will be to evaluate and compare the intraoperative hemodynamic parameter with intravenous dexmedetomidine and cloniodine as premedication during laproscopic surgeries in general anaesthesia.The secondary outcomes will be to evaluate side effects of intravenous dexmedetomidine and clonidine. 
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