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CTRI Number  CTRI/2020/01/022685 [Registered on: 10/01/2020] Trial Registered Prospectively
Last Modified On: 08/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between oral clonidine and oral pregabalin tablet on vitals during operation and pain duration after laproscopic gall bladder operation 
Scientific Title of Study   A comparative study between oral clonidine and oral pregabalin on perioperative haemodynamic response and post operative analgesia in patients undergoing laparoscopic cholecystectomy under 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  Dr Rajendrapal Singh Rathore 
Designation  Postgraduate student 
Affiliation  Jawahar lal nehru medical college, Ajmer 
Address  Department of anaesthesiology, JLN medical college, ajmer, rajasthan Ajmer RAJASTHAN 305001 India
JLN medical college, ajmer, rajasthan Ajmer RAJASTHAN 305001 India
Ajmer
RAJASTHAN
305001
India 
Phone  9672140069  
Fax    
Email  drrajendrapalsingh0952@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena mathur 
Designation  Senior professor 
Affiliation  Jawahar lal nehru medical college, Ajmer 
Address  Department of anaesthesiology, JLN medical college, ajmer, rajasthan Ajmer RAJASTHAN 305001 India
Department of anaesthesiology, JLN medical college, ajmer, rajasthan Ajmer RAJASTHAN 305001 India
Ajmer
RAJASTHAN
305001
India 
Phone  949460517947  
Fax    
Email  veenamathur41@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Veena mathur 
Designation  Senior professor 
Affiliation  Jawahar lal nehru medical college, Ajmer 
Address  Department of anaesthesiology, JLN medical college, ajmer, rajasthan Ajmer RAJASTHAN 305001 India
Department of anaesthesiology, JLN medical college, ajmer, rajasthan Ajmer RAJASTHAN 305001 India
Ajmer
RAJASTHAN
305001
India 
Phone  949460517947  
Fax    
Email  veenamathur41@gmail.com  
 
Source of Monetary or Material Support  
J.L.N. Medical College and Hospitals, Ajmer 
 
Primary Sponsor  
Name  JLN Medical college and hospital Ajmer 
Address  Department of anaesthesiology, J.L.N. Medical College, Ajmer, Rajasthan 
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 
Rajendrapal singh rathore  J.L.N. Medical college   Department of anaesthesiology J.L.N. Medical hospital,ajmer Ajmer RAJASTHAN
Ajmer
RAJASTHAN 		 9672140069

drrajendrapalsingh0952@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee,J.L.N. medical college Ajmer  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral Clonidine 200 µg or Oral Pregabalin 150 mg once 120 minutes prior to surgery   Haemodynamic changes Post operative analgesia and Level of Sedation will be assessed upto 24 hours postoperatively and duration of study is around 1 year 
Intervention  Oral tablet  Haemodynamic changes Post operative analgesia Level of Sedation will be assessed upto 24 hours postoperatively and duration of study is around 1 year  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients of ASA grade I and II aged between 18 and 60 years of either sex posted for laparoscopic cholecystectomy surgery under general anaesthesia 
 
ExclusionCriteria 
Details  ASA grade III and above.
Age <18 years & > 60 years.
Patients with severe systemic disease like IDDM, uncontrolled hypertension, kidney and liver disease, severe respiratory disease.
Seizure disorder.
Coronary artery disease or recent history of MI.
Anticipated difficult intubation.
Body weight>100 kg or obese.
Pregnant and lactating women.
Mentally impaired patients.
Patients of psychiatric disorders and sleep disorders.
Patients on steroids since last 6 months.
Hypersensitivity to study drugs.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Haemodynamic changes
 		 1 year
 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative analgesia
Level of Sedation
Any significant side effects or complications.

 		 1 year 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   11/01/2020 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The aim of this study is to compare and evaluate the efficacy of two different drug oral clonidine and oral pregabalin in perioperative haemodynamic response to laryngoscopy, endotracheal intubation, pneumoperitonium and post operative analgesia and sedation with respect to-

PRIMARY OBJECTIVE-

  1. Haemodynamic changes  

SECONDARY OBJECTIVES-

  1. Post operative analgesia

  2. Level of Sedation

  3. Any significant side effects or complications

 
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