Home » Trials » SLCTR/2018/032
Comparison of pregabalin and lignocaine for attenuating stress response during intubation in hypertensive patients
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SLCTR Registration Number
SLCTR/2018/032
Date of Registration
The date of last modification
Mar 03, 2019
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 or Health Condition(s) Studied
Hypertension
Scientific Acronym
None
Public Acronym
None
Brief title
The efficacy of pregabalin vs lignocaine in attenuating the hypertensive response in hypertensive patients
Universal Trial Number
U1111-1218-8292
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
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Uncontrolled
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
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.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
|
[ Immediately after Intubation ] |
Secondary outcome(s)
1.
|
[ 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
India
Anticipated start date
2018-10-15
Anticipated end date
2019-06-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Status
Approved
Date of Approval
2018-08-23
Approval number
VMMC07/2308/18
Details of Ethics Review Committee
Name: | nstitutional Ethics Committee, Vinayaka Missions Medical College, |
Institutional Address: | Karaikal 609609, India. |
Telephone: | Not available |
Email: | Not available |
Contact person for Scientific Queries/Principal Investigator
Prasanna Vadhanan
Professor
Department of Anaesthesiology,
Vinayaka Missions medical college,
Karaikal 609609,
India
Tel: +919486489690
vadhanan.prasanna@gmail.com
Contact Person for Public Queries
Revathy Prakash
Junior resident
Vinayaka Missions Medical College,
Karaikal 609609,
India
Tel: +919486489690
vadhanan@outlook.com
Primary study sponsor/organization
Vinayaka Missions Medical College
Karaikal,
India
Tel: +91 4368 263 340
Fax : +91 427 2477903
vmtrust@vinayakamission.com
http://www.vmmckkl.edu.in
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results