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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.
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:
Patients groups will be determined by sex and age group (18-60 or >60 years old), therefore, four independent groups will be studied:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Continuous infusion, variable dose of lidocaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cough during anesthesia emergence | Dichotomic variable, true if any cough is detected from anesthesia weaning to extubation. | Anytime during anesthesia emergence, before extubation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriel MN Guimaraes, MSc | Contact | +55 61 996455997 | gabrielmng@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Brasilia | Recruiting | BrasÃlia | Federal District | 70000000 | Brazil |
we will make IPD available in www.anestesiologiaunb.com.br
In a year following the study
Open
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Four parallel groups will be studied:
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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.
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |