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

11 Oct 2018

The date of last modification

Jan 28, 2019



Application Summary


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


Trial Details


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

  1. Males and females under the age limit of 60 years
  2. Undergoing elective surgery requiring general anaesthesia
  3. Hypertensive patients on antihypertensive medications with BP (blood pressure) less than or equal to 160/90 mmHg

Exclusion criteria

  1. Uncontrolled hypertension defined as blood pressure above 160/90 mmHg
  2. Significant cardiorespiratory illness such as IHD, left heart failure, severe COPD and cor pulmonale
  3. Psychiatric medication including sedative intake (Tricyclic antidepressants, Selective serotonin reuptake inhibitors, Serotonin and norepinephrine reuptake inhibitors)


Primary outcome(s)

    1. Change in pulse rate
    2. Change in mean arterial pressure
    [

    Immediately after Intubation

    ]

Secondary outcome(s)

    1. Laryngospasm
    2. Arrthymias
    3. Time taken for patients to respond to verbal commands from the termination of general anaesthesia
    [

    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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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