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Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence

Primary Purpose

Cough

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
Brasilia University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cough focused on measuring general anesthesia, cough, anesthesia emergence, lidocaine

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario de BrasiliaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Female 18 to 60 years old

Male 18 to 60 years old

Male > 60 years old

Female > 60 years old

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Cough during anesthesia emergence
Dichotomic variable, true if any cough is detected from anesthesia weaning to extubation.

Secondary Outcome Measures

Full Information

First Posted
December 26, 2017
Last Updated
January 14, 2019
Sponsor
Brasilia University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03805282
Brief Title
Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence
Official Title
Intravenous Lidocaine Continuous-infusion to Supress of Cough Reflex During Anesthesia Emergence: Dose-finding Adaptive Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 15, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brasilia University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
Keywords
general anesthesia, cough, anesthesia emergence, lidocaine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Four parallel groups will be studied: Female > 60 years old Male > 60 years old Female 18 to 60 years old Male 18 to 60 years old
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
A study participant who will not participate during assessment of the main outcome will prepare the drug solutions to be infused at 10ml/h accordingly to the response of the previous patient and to the dose calculated for the next patient. The participant who will verify the main outcome during anesthesia emergence will not know the dose the patient is receiving. Participants will not be informed of the dose they will receive. The outcomes assessor will not handle individual data and statistical analysis plan was developed in advance.
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Female 18 to 60 years old
Arm Type
Experimental
Arm Description
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.
Arm Title
Male 18 to 60 years old
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Male > 60 years old
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Female > 60 years old
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Xylocaine
Intervention Description
Continuous infusion, variable dose of lidocaine.
Primary Outcome Measure Information:
Title
Cough during anesthesia emergence
Description
Dichotomic variable, true if any cough is detected from anesthesia weaning to extubation.
Time Frame
Anytime during anesthesia emergence, before extubation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel MN Guimaraes, MSc
Phone
+55 61 996455997
Email
gabrielmng@gmail.com
Facility Information:
Facility Name
Hospital Universitario de Brasilia
City
Brasília
State/Province
Distrito Federal
ZIP/Postal Code
70000000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel MN Guimaraes, MSc
Phone
+55 61 996455997
Email
gabrielmng@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.anestesiologiaunb.com.br

Learn more about this trial

Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence

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