Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence

Brasilia University Hospital

Status and phase: Unknown; Phase 3

Conditions: Cough

Treatments: Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03805282

LidoTosse

Details and patient eligibility

About

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.

Full 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

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 4 patient groups

Female 18 to 60 years old

Experimental group

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.

Treatment:

Drug: Lidocaine

Male 18 to 60 years old

Active Comparator group

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.

Treatment:

Drug: Lidocaine

Male > 60 years old

Active Comparator group

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.

Treatment:

Drug: Lidocaine

Female > 60 years old

Active Comparator group

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.

Treatment:

Drug: Lidocaine