Home » Trials » SLCTR/2018/032

Comparison of pregabalin and lignocaine for attenuating stress response during intubation in hypertensive patients


SLCTR Registration Number


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


Scientific Acronym


Public Acronym


Brief title

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

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


Study design


Randomized controlled trial


Double blinded







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


Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source

None (Investigator funded)

Regulatory approvals

State of Ethics Review Approval



Date of Approval


Approval number


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
Department of Anaesthesiology, Vinayaka Missions medical college, Karaikal 609609, India
Tel: +919486489690


Contact Person for Public Queries

Revathy Prakash
Junior resident
Vinayaka Missions Medical College, Karaikal 609609, India
Tel: +919486489690


Primary study sponsor/organization

Vinayaka Missions Medical College

Karaikal, India
Tel: +91 4368 263 340
Fax : +91 427 2477903

Secondary study sponsor (If any)


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


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results