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
|
|
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
|
|
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. |