Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence

Phase 3

• Conditions: Cough
• Interventions: Drug: Lidocaine

• Registration Number: NCT03805282
• Lead Sponsor: Brasilia University Hospital

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

Study Timeline

• Study First Submitted: 2017-12-26
• Study Start: 2018-03-01
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-14
• Last Update Submitted: 2019-01-14
• Study First Posted: 2019-01-15
• Last Update Posted: 2019-01-15
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Female 18 to 60 years old	Lidocaine	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.
Female > 60 years old	Lidocaine	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.
Male 18 to 60 years old	Lidocaine	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.
Male > 60 years old	Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
Cough during anesthesia emergence	Anytime during anesthesia emergence, before extubation.	Dichotomic variable, true if any cough is detected from anesthesia weaning to extubation.

Trial Locations

Locations (1)

Hospital Universitario de Brasilia; 🇧🇷 Brasília, Distrito Federal, Brazil