Lidocaine to Prevent Cough and Hemodynamic Changes in Tracheal Extubation

Lidocaine Clinical Trial

Official title:

Efficiency of Intravenous Lidocaine to Reduce Coughing and the Hemodynamic Changes Associated to Tracheal Extubation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03731429
• Other study ID #: 201824
• Status: Recruiting
• Phase: Phase 4
• Start date: April 5, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: February 2020
• Source: Hospital Fernandez
• Contact: Sofia De Estrada, Doctor
• Phone: +5491151096340
• Email: sofiaestrada89[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: November 1, 2020
• Est. primary completion date: September 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

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).

Related Conditions & MeSH terms

• Lidocaine

Intervention

Drug:
• Lidocaine
prior to extubation
• Saline Solution
Prior to extubation

Locations

Country	Name	City	State
Argentina	Hospital Fernandez	Capital federal	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Fernandez

Country where clinical trial is conducted

Argentina, 

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Monitor the adverse reactions (AR) that may occur after the administration of IV lidocaine and report them	Severe and unexpected AR shall be reported according to Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) with the means appropriate and intended for that purpose. Likewise, this scenario will be immediately reported to the Fernández hospital Ethics and Research Committee.	24 hours after extubation
Primary	Determine the efficiency of IV lidocaine in reducing the incidence of coughing	Apply the Minogue scale to assess the coughing associated to tracheal extubation.; Modified Minogue scale by Likert: (ordinal, 0 to 5); Grade 1: absence of coughing and muscle stiffness Grade 2: transient coughing while removing EDT Grade 3: moderate cough (3 or less coughing episodes each lasting one or two seconds) Grade 4: muscular stiffness or severe cough (4 ore more episodes lasting more tham two seconds) Grade 5: laryngospasm	From the moment the endotracheal tube is retired to 5 minutes after
Primary	Determine the efficiency of IV lidocaine in reducing the arterial hypertension associated with tracheal extubation	Gather mean arterial pressure (MAP) record at the time of the extubation.; Difference in MAP between anesthesia ceasing (time 0) and extubation (time 2) (continuous, mmHg) Difference in MAP between time 0 and 5 minutes after extubation (time 3) (continuous, mmHg)	From the end of anesthesia to 5 minutes after tracheal extubation (At time 0, time 2 and time 3)
Primary	Determine the efficiency of IV lidocaine in reducing the increase in heart rate (HR) associated with tracheal extubation	Gather HR record at the time of the extubation.; Difference in HR between time 0 and time 2 (discreet, bpm) Difference in HR between time 0 and time 3 (discreet, bpm)	From the end of anesthesia to 5 minutes after tracheal extubation (At time 0, time 2 and time 3)
Secondary	Record the time elapsed from the end of anesthesia and the administration of lidocaine to extubation.	As a safety event. Record time between t0 and t2 (continuous, minutes)	Intraoperative. From the end of anesthesia (time 0) to tracheal extubation (time 2)
Secondary	Assess immediate POP sore throat	using the Likert ten-point severity pain scale. The scale ranges from 0 to 10. 0 equals no pain, and 10 indicates the worst pain.	30 minutes after extubation