- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03805282
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
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 Contact
- Name: Gabriel MN Guimaraes, MSc
- Phone Number: +55 61 996455997
- Email: gabrielmng@gmail.com
Study Locations
-
-
Distrito Federal
-
Brasília, Distrito Federal, Brazil, 70000000
- Recruiting
- Hospital Universitário de Brasília
-
Contact:
- Gabriel MN Guimaraes, MSc
- Phone Number: +55 61 996455997
- Email: gabrielmng@gmail.com
-
-
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.
|
Continuous infusion, variable dose of lidocaine.
Other Names:
|
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.
|
Continuous infusion, variable dose of lidocaine.
Other Names:
|
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.
|
Continuous infusion, variable dose of lidocaine.
Other Names:
|
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.
|
Continuous infusion, variable dose of lidocaine.
Other Names:
|
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
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
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Signs and Symptoms, Respiratory
- Cough
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
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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