SLCTR Registration Number
Date of Registration
The date of last modification
Oct 11, 2018
Scientific Title of Trial
Comparison of pregabalin and lignocaine for attenuating stress response during intubation in hypertensive patients
Public Title of Trial
A randomized controlled trial comparing the efficacy of pregabalin versus lignocaine for attenuating the intubation response in hypertensive patients.
Disease of Health Condition(s) Studied
The efficacy of pregabalin vs lignocaine in attenuating the hypertensive response in hypertensive patients
Universal Trial Number
Any other number(s) assigned to the trial and issuing authority
Institutional Ethics Committee, Vinayaka Missions Medical College, Karaikal. VMMC07/2308/18
What is the research question being addressed?
Can oral pregabalin compared to lignocaine attenuate the stress response during intubation in hypertensive patients?
Type of study
Randomized controlled trial
The study setting will be a teaching hospital in South India
The patients will be randomized according to computer generated randomization tables in blocks of 5
The control arm will receive IV lignocaine 1.5mg/kg, 3 minutes before and a placebo capsule 45 minutes before intubation
The active arm will receive oral pregabalin 75mg, 45 minutes before and a saline infusion 3 minutes before intubation.
Immediately before general anaesthesia is administered, the baseline pulse rate and blood pressure will be recorded.
Participants, data collector and data analysts will be blinded.
Primary outcome(s) - Time of assessment(s)
Immediately after Intubation
Secondary outcome(s) - Time of assessment(s)
Outcomes 1 and 2 will be assessed immediately after anaesthesia
Outcome 3 will be assessed every 5 minutes till the patient responds to verbal commands
Target number/sample size
120 (60 patients per arm)
Countries of recruitment
Anticipated start date
Anticipated end date
State of ethics review approval
Approved by Institutional Ethical Committee, Vinayaka Mission’s Medical College, Karaikal, India on 23rd August 2016 (valid for 3 years) VMMC07/2308/18
None (Investigator funded)
Contact person for Scientific Queries/Principal Investigator
Department of Anaesthesiology, Vinayaka Missions medical college, Karaikal 609609, India
Contact Person for Public Queries
Vinayaka Missions Medical College, Karaikal 609609, India