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CTRI Number  CTRI/2017/09/009862 [Registered on: 20/09/2017] Trial Registered Retrospectively
Last Modified On: 18/09/2017
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 of the effects of Pregabalin, Dexmedetomidine, and their combination on the haemodynamic response and anaesthetic requirements 
Scientific Title of Study   Comparative Evaluation Of The Effects Of Premedication With Pregabalin, Dexmedetomidine, and Their Combination On the Haemodynamic Response and Anaesthetic Requirements in patients undergoing Laparoscopic Cholecystectomy- A Randomised Double Blind Prospective Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naveen K V 
Designation  post graduate 
Affiliation  VMMC and Safdarjung Hospital 
Address  VMMC and Safdarjung Hospital, New Delhi II0029 India
Department of Anaesthesia
New Delhi
DELHI
110029
India 
Phone  8826773497  
Fax    
Email  naveenkvijayan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vandana Talwar 
Designation  consultant and professor 
Affiliation  VMMC AND SAFDARJUNG HOSPITAL 
Address  VMMC AND SAFDARJUNG HOSPITAL, NEW DELHI II0029 INDIA

New Delhi
DELHI
110029
India 
Phone  9811352251  
Fax    
Email  drvandanatalwar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Naveen K V 
Designation  post graduate 
Affiliation  VMMC and Safdarjung Hospital 
Address  VMMC and Safdarjung Hospital, New Delhi II0029 India
Department of Anaesthesia
New Delhi
DELHI
110029
India 
Phone  8826773497  
Fax    
Email  naveenkvijayan@gmail.com  
 
Source of Monetary or Material Support  
VMMC and Safdarjung Hospital, New Delhi. 110029. 
 
Primary Sponsor  
Name  VMMC and Safdarjung Hospital 
Address  VMMC and Safdarjung Hospital, New Delhi 110029 India 
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 
Naveen K V  SAFDARJUNG HOSPITAL  Operation theatre ,second floor, Department of Anaesthesia, VMMC and Safdarjung Hospital, New Delhi, 110029 India
New Delhi
DELHI 
8826773497
8826773497
naveenkvijayan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, VMMC and Safdarjung Hospital, New Delhi, 110029  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA Grade 1 and 2,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combination group will receive a combination of oral pregabalin 75mg one hour before induction, and a bolus intravenous dose of dexmedetomidine @0.5µg/kg(prepared in 100ml 0.9%normal saline) over 10minutes, ten minutes before induction  Combination group will receive a combination of oral pregabalin 75mg one hour before induction, and a bolus intravenous dose of dexmedetomidine @0.5µg/kg(prepared in 100ml 0.9%normal saline) over 10minutes, ten minutes before induction 
Comparator Agent  Dexmedetomidine group will receive a bolus intravenous dose of dexmedetomidine @1µg/kg over(prepared in 100ml 0.9%normal saline) over 10minutes, ten minutes before induction, and oral placebo tablet one hour before induction  Dexmedetomidine group will receive a bolus intravenous dose of dexmedetomidine @1µg/kg over(prepared in 100ml 0.9%normal saline) over 10minutes, ten minutes before induction, and oral placebo tablet one hour before induction 
Comparator Agent  Pregabalin group will receive oral pregabalin 150mg one hour before induction, and intravenous normal saline(0.9%) 100ml over 10minutes, 10minutes before induction.  Pregabalin group will receive oral pregabalin 150mg one hour before induction, and intravenous normal saline(0.9%) 100ml over 10minutes, 10minutes before induction. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients scheduled to undergo elective laparoscopic cholecystectomy.
ASA grades 1 and 2.
Adult patients 18-65 years of age of either sex.
 
 
ExclusionCriteria 
Details  1) patients with hypertension,morbid obesity, and cardiac, renal, hepatic, endocrine or pulmonary dysfunction
2) ASA grades 3 and 4 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
pulse,blood pressure,oxygen saturation,end tidal carbon dioxide, isoflurane concentration,fentanyl requirement, propofol requirement, ramsay sedation score, Visual Analogue Scale  baseline, 10, 20,30,40,45,50,55,60 minutes after premedication
before induction, after 1,2,3 minutes of induction, after 1,3,5,10,15,30,45,60,75 minutes of intubation, before, after and end of pneumoperitoneum
15 minutes, 1 hour, 2 hours after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
time taken for patient to respond after reversal, time taken for extubation after reversal  15 minutes, 60 minutes, and 120 minutes postoperatively 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   05/11/2012 
Date of Study Completion (India) 24/01/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Bhattacharjee DP, Nayek SK, Dawn S, Bandopadhyay G, Gupta K. Effects of dexmedetomidine on haemodynamics in patients undergoing laparoscopic cholecystectomy- A Comparative Study. Journal of Anaesthesiology Clinical Pharmacology. 2010; 26(1):45-48. Rastogi B, Gupta K, Gupta PK, Agarwal S, Jain M, Chauhan H. Oral pregabalin premedication for attenuation of haemodynamic pressor response of airway instrumentation during general anaesthesia: A dose response study. Indian Journal of Anaesthesia. 2012; 56(1): 49-54. Gurbet A, Mogol EB, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of dexmedetomidine reduces perioperative analgesic requirements. Canadian Journal of Anaesthesia. 2006; 53(7): 646-652. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   arterial pressures  and anaesthetic requirements were significantly lower in the dexmedetomidine group in the perioperative period as compared to the other two groups. 
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