NCT03805282

Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Brasilia University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	Lidocaine	Continuous infusion, variable dose of lidocaine.

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-12-15
• Completion: 2019-12-31
• First posted: 2019-01-15
• Last updated: 2019-01-15

Locations

1 site across 1 country: Brazil