Intravenous Lignocaine vs Placebo

December 24, 2018 updated by: Indus Hospital and Health Network

Effect of Intravenous Lignocaine vs Placebo on Hemodynamic Response During Intubation

To assess the mean hemodynamic responses post-intubation in patients given intravenous lignocaine pre-intubation as compared to a placebo pre-intubation in patients undergoing laryngoscopy surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After identifying the candidate, details will be carefully discussed with the subject. The subject (or, when necessary, the parent or legal guardian if the subject is younger than 18 years of age or under guardianship) will be read the approved protocol consent form. Patients who have given informed consent to participate in the study will be randomized into one of the two study arms one day before the procedure. The study team present will open the sealed envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study arm allocation. The envelopes will follow the SNOSE protocol.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sind
      • Karachi, Sind, Pakistan, 75500
        • The Indus Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I and II
  • Age 20-60 years
  • Mallampatti , II
  • All surgeries are done under GA
  • Both genders
  • Those patients giving informed consent

Exclusion Criteria:

  • Difficult airway assessed during pre-op anaesthesia assessment
  • Unanticipated difficult airway based on the previous history of difficult intubation
  • BMI >30,
  • Micrognathia and microglossia based on pre-op anaesthesia assessment,
  • Diabetic patient with autonomic dysfunction liver disease, cardiovascular disease, pheochromocytoma, Cushing syndrome
  • Patients who do not give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lignocaine group
This group will be given 1.5 mg/kg I/V lignocaine before intubation
Drug: iv Lignocaine vs placebo
Lignocaine is available in an ampule of 10 ml containing 20 mg/ml of lignocaine or 2%, Lignocaine will be given in dose of 1.5 mg/kg I/V
Placebo Comparator: Placebo
This group will be given 6 ml normal saline before intubation
Drug: iv Lignocaine vs placebo
Lignocaine is available in an ampule of 10 ml containing 20 mg/ml of lignocaine or 2%, Lignocaine will be given in dose of 1.5 mg/kg I/V

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MAP
Time Frame: post-intubation 3 minutes to 10 minutes
mean arterial pressure
post-intubation 3 minutes to 10 minutes
Pulse
Time Frame: post-intubation 3 minutes to 10 minutes
Heart rate
post-intubation 3 minutes to 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indus Hospital and Health Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2017

Primary Completion (Actual)

July 20, 2018

Study Completion (Actual)

July 20, 2018

Study Registration Dates

First Submitted

December 24, 2018

First Submitted That Met QC Criteria

December 24, 2018

First Posted (Actual)

December 26, 2018

Study Record Updates

Last Update Posted (Actual)

December 26, 2018

Last Update Submitted That Met QC Criteria

December 24, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRD_IRB_2017_07_002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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