Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence

January 14, 2019 updated by: Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital

Intravenous Lidocaine Continuous-infusion to Supress of Cough Reflex During Anesthesia Emergence: Dose-finding Adaptive Trial

Introduction: Although inflating tracheal cuff using lidocaine is effective for cough suppression, it may pressure tracheal cuff too much. Intravenous continuous infusion of lidocaine has emerged recently for most general anesthesia in the context of opioid-sparing anesthesia for cancer, but the 95% effective dose (ED95) for cough suppression during anesthesia emergence is not determined yet. Objective: the objectives of this study are to determine the ED95 of continuous infusion lidocaine for suppressing cough reflex during extubation by sex and age group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Ideal patient weight in kg will be considered.

Initial dose will be 0.5mg/kg.h and dose-change steps of 0.5mg/kg.h will occur depending on the incidence of emergence cough in the previous patient of the same group:

  • It will increase if coughed in a probability of 95%
  • It will decrease if not coughed in a probability of 5%.
  • It will remain the same otherwise. Maximum dose will be 3mg/kg.h. All patients will receive remifentanil 0.025mcg/kg.min continuous infusion until extubation.

Patients groups will be determined by sex and age group (18-60 or >60 years old), therefore, four independent groups will be studied:

  • Female 18 to 60 years old
  • Male 18 to 60 years old
  • Female > 60 years old
  • Male > 60 years old

Study Type

Interventional

Enrollment (Anticipated)

132

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

  • Brazil
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 70000000
        • Recruiting
        • Hospital Universitario de Brasilia
        • Contact:

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 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Understands study risks and benefits, signs informed consent.
  • Not pregnant.
  • Not an airway surgery
  • No acute or chronic respiratory disease.
  • Non smoker
  • No chronic cough

Exclusion Criteria:

  • Any protocol violation.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Female 18 to 60 years old
This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.
Drug: Lidocaine
Continuous infusion, variable dose of lidocaine.
Other Names:
  • Xylocaine
Active Comparator: Male 18 to 60 years old
This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.
Drug: Lidocaine
Continuous infusion, variable dose of lidocaine.
Other Names:
  • Xylocaine
Active Comparator: Male > 60 years old
This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.
Drug: Lidocaine
Continuous infusion, variable dose of lidocaine.
Other Names:
  • Xylocaine
Active Comparator: Female > 60 years old
This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.
Drug: Lidocaine
Continuous infusion, variable dose of lidocaine.
Other Names:
  • Xylocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cough during anesthesia emergence
Time Frame: Anytime during anesthesia emergence, before extubation.
Dichotomic variable, true if any cough is detected from anesthesia weaning to extubation.
Anytime during anesthesia emergence, before extubation.

Collaborators and Investigators

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

Sponsor

Brasilia University Hospital

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)

March 1, 2018

Primary Completion (Anticipated)

December 15, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

December 26, 2017

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LidoTosse

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

we will make IPD available in www.anestesiologiaunb.com.br

IPD Sharing Time Frame

In a year following the study

IPD Sharing Access Criteria

Open

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

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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