Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03805282
• Other study ID #: LidoTosse
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2019
• Source: Brasilia University Hospital
• Contact: Gabriel MN Guimaraes, MSc
• Phone: +55 61 996455997
• Email: gabrielmng[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 31, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• Lidocaine
Continuous infusion, variable dose of lidocaine.

Locations

Country	Name	City	State
Brazil	Hospital Universitario de Brasilia	Brasília	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough during anesthesia emergence	Dichotomic variable, true if any cough is detected from anesthesia weaning to extubation.	Anytime during anesthesia emergence, before extubation.