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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03805282
Enrollment
132
Registered
2019-01-15
Start date
2018-03-01
Completion date
2019-12-31
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough

Keywords

general anesthesia, cough, anesthesia emergence, lidocaine

Brief 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

Interventions

DRUGLidocaine

Continuous infusion, variable dose of lidocaine.

Sponsors

Brasilia University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

Four parallel groups will be studied: * Female \> 60 years old * Male \> 60 years old * Female 18 to 60 years old * Male 18 to 60 years old

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cough during anesthesia emergenceAnytime during anesthesia emergence, before extubation.Dichotomic variable, true if any cough is detected from anesthesia weaning to extubation.

Countries

Brazil

Contacts

Primary ContactGabriel MN Guimaraes, MSc
gabrielmng@gmail.com+55 61 996455997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026