Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence

NCT03805282 | Unknown Phase 3

• 1 other identifier: LidoTosse
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Keywords

general anesthesia; cough; anesthesia emergence; lidocaine

Outcome Measures

Primary Outcomes (1)

• Cough during anesthesia emergence

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

  Anytime during anesthesia emergence, before extubation.

Study Arms (4)

Female 18 to 60 years old

EXPERIMENTAL

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

Male 18 to 60 years old

ACTIVE COMPARATOR

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

Male > 60 years old

ACTIVE COMPARATOR

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

Female > 60 years old

ACTIVE COMPARATOR

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

Interventions

Lidocaine DRUG

Continuous infusion, variable dose of lidocaine.

Also known as: Xylocaine

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any protocol violation.

Sponsors & Collaborators

• Brasilia University Hospital: lead

Study Sites (1)

Hospital Universitario de Brasilia

Brasília, Federal District, 70000000, Brazil

RECRUITING

MeSH Terms

Conditions

Cough

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Gabriel MN Guimaraes, MSc

CONTACT

+55 61 996455997; gabrielmng@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology

Model Details: 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

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 15, 2019
• Study Start: March 1, 2018
• Primary Completion: December 15, 2019
• Study Completion: December 31, 2019
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: In a year following the study
• Access Criteria: Open

Locations

BR (1)