Lidocaine to Prevent Cough and Hemodynamic Changes in Tracheal Extubation
NCT ID: NCT03731429
Last Updated: 2020-02-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
144 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-04-05
Study Completion Date
2020-11-01
Brief Summary
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Coughing during tracheal extubation can be associated to adverse effects like tachycardia, arterial hypertension (AHT), increase of intracranial pressure (ICP) and intraocular pressure (IOP), and the dehiscence of surgical wounds. In ophthalmic, head and neck, and abdominal surgery, and in several other neurosurgical interventions it is vital to prevent these effects. The incidence of laryngeal irritation due to orotracheal intubation hinders patient comfort in the immediate postoperative (POP) period and no pharmacological intervention has been yet proven to prevent it.
At the end of the surgical procedure, the depth of the anesthetic plane decreases with the concomitant suspension of the anesthetic agents. However, the patient still requires ventilatory support through the endotracheal tube (EDT). The physical stimulation of the trachea created by this foreign body leads to the activation of the sympathetic nervous system, expressed in AHT, tachycardia, and ICP. To tolerate the EDT and prevent these effects, different maneuvers have been tested such as extubating the patient in a deep anesthetic plane or administering intravenous (IV) narcotics with the entailed complications: airway (AW) obstruction and hypercapnia, and the aspiration of an unprotected AW. Progress has been made with the introduction of ultrashort acting opioids, with significant statistical results. Moreover, beta-blockers, calcium channel blockers, angiotensin converting enzyme inhibitors and dexmedetomidine have been used to decrease the hemodynamic impact associated to tracheal extubation. The use of both IV and intratracheal lidocaine in doses ranging from 1 mg/kg to 3 mg/kg, has been studied with controversial results.
In view of the above, and as lidocaine is the most commonly used low-cost drug in all operating rooms with a good safety profile when used at low doses, the purpose of this study is twofold: to assess its effects at reducing coughing and to evaluate its hemodynamic impact when administering IV 1 mg/kg prior to extubation. Then, the efficiency of reducing the incidence of sore throats after the immediate POP shall be investigated.
At the end of the surgical procedure, the depth of the anesthetic plane decreases with the concomitant suspension of the anesthetic agents. However, the patient still requires ventilatory support through the endotracheal tube (EDT). The physical stimulation of the trachea created by this foreign body leads to the activation of the sympathetic nervous system, expressed in AHT, tachycardia, and ICP. To tolerate the EDT and prevent these effects, different maneuvers have been tested such as extubating the patient in a deep anesthetic plane or administering intravenous (IV) narcotics with the entailed complications: airway (AW) obstruction and hypercapnia, and the aspiration of an unprotected AW. Progress has been made with the introduction of ultrashort acting opioids, with significant statistical results. Moreover, beta-blockers, calcium channel blockers, angiotensin converting enzyme inhibitors and dexmedetomidine have been used to decrease the hemodynamic impact associated to tracheal extubation. The use of both IV and intratracheal lidocaine in doses ranging from 1 mg/kg to 3 mg/kg, has been studied with controversial results.
In view of the above, and as lidocaine is the most commonly used low-cost drug in all operating rooms with a good safety profile when used at low doses, the purpose of this study is twofold: to assess its effects at reducing coughing and to evaluate its hemodynamic impact when administering IV 1 mg/kg prior to extubation. Then, the efficiency of reducing the incidence of sore throats after the immediate POP shall be investigated.
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Detailed Description
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Conditions
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Lidocaine
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This study was designed as a double-blind randomized controlled trial
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
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Intervention
Group that receives a 1 mg/kg single bolus of 2% IV lidocaine
Group Type
EXPERIMENTAL
Lidocaine
Intervention Type
DRUG
prior to extubation
Placebo
group that receives 0.9% saline solution
Group Type
PLACEBO_COMPARATOR
Saline Solution
Intervention Type
DRUG
Prior to extubation
Interventions
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Lidocaine
prior to extubation
Intervention Type
DRUG
Saline Solution
Prior to extubation
Intervention Type
DRUG
Other Intervention Names
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GOBBI
GOBBI
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists Risk I \& II.
* Age 18-65 years.
* Scheduled for: cholecystectomy, hernioplasty or laparoscopic gynecological surgery, under balanced general anesthesia (GA) and orotracheal intubation (OTI).
* Age 18-65 years.
* Scheduled for: cholecystectomy, hernioplasty or laparoscopic gynecological surgery, under balanced general anesthesia (GA) and orotracheal intubation (OTI).
Exclusion Criteria
* Local anesthetic (LA) allergy.
* Presence of predictors of potentially difficult intubation (DI) according to criteria defined by the American Society of Anesthesiologists.
* Upper airway inflammatory symptoms during the previous week.
* Chronic kidney disease with clearance lower than 60 ml/m using the Modification of Diet in Renal Disease (MDRD) equation.
* Child-Pugh B-C liver disease.
* Treated with ACEinhibitors and/or BB.
* Second and third grade atrioventricular block.
* Symptomatic bradycardia.
* Tachyarrhythmias.
* Left bundle branch block (LBBB).
* Presence of predictors of potentially difficult intubation (DI) according to criteria defined by the American Society of Anesthesiologists.
* Upper airway inflammatory symptoms during the previous week.
* Chronic kidney disease with clearance lower than 60 ml/m using the Modification of Diet in Renal Disease (MDRD) equation.
* Child-Pugh B-C liver disease.
* Treated with ACEinhibitors and/or BB.
* Second and third grade atrioventricular block.
* Symptomatic bradycardia.
* Tachyarrhythmias.
* Left bundle branch block (LBBB).
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hospital Fernandez
OTHER
Sponsor Role
lead
Responsible Party
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Santiago Ficcadenti
Principal investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Santiago Ficcadenti, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Fernandez
Locations
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Hospital Fernandez
Capital Federal, Buenos Aires, Argentina
Site Status
RECRUITING
Countries
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Argentina
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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201824
Identifier Type: -
Identifier Source: org_study_id
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