A Phase 3 interventional study of Lidocaine in Cough, sponsored by Brasilia University Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by Brasilia University Hospital · Phase 3, Interventional, and Prevention
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:
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's planned enrollment of 132 is above the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →Brasilia University Hospital is the lead sponsor of 20 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: 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.
Drug: 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.
Drug: 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.
Drug: Lidocaine
Continuous infusion, variable dose of lidocaine.
Also known as: Xylocaine
Cough during anesthesia emergence
Dichotomic variable, true if any cough is detected from anesthesia weaning to extubation.
Time frame: Anytime during anesthesia emergence, before extubation.
Plan to share: Yes — we will make IPD available in www.anestesiologiaunb.com.br
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: In a year following the study
Access criteria: Open
Data sharing details ↗ · www.anestesiologiaunb.com.br
No publications or documents are linked to this record.
Started Mar 2018 (actual). Primary completion is estimated for Dec 2019, 21 months after the start.
Of 18 phase 3 interventional studies under Cough, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 37. This study's planned 21 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
Brasilia University Hospital