Lidocaine to Prevent Cough and Hemodynamic Changes in Tracheal Extubation

Sponsor

Hospital Fernandez (Other)

Overall Status

Unknown status

CT.gov ID

NCT03731429

Collaborator

(none)

144

Enrollment

Location

Arms

18.9

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lidocaine	Drug: Lidocaine Drug: Saline Solution	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study was designed as a double-blind randomized controlled trialThis study was designed as a double-blind randomized controlled trial

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 5, 2019

Anticipated Primary Completion Date :

Sep 19, 2020

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group that receives a 1 mg/kg single bolus of 2% IV lidocaine	Drug: Lidocaine prior to extubation Other Names: GOBBI
Placebo Comparator: Placebo group that receives 0.9% saline solution	Drug: Saline Solution Prior to extubation Other Names: GOBBI

Arm

Intervention/Treatment

Experimental: Intervention

Group that receives a 1 mg/kg single bolus of 2% IV lidocaine

Drug: Lidocaine

prior to extubation

Other Names:

GOBBI

Placebo Comparator: Placebo

group that receives 0.9% saline solution

Drug: Saline Solution

Prior to extubation

Other Names:

GOBBI

Outcome Measures

Primary Outcome Measures

Determine the efficiency of IV lidocaine in reducing the incidence of coughing [From the moment the endotracheal tube is retired to 5 minutes after]
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
Determine the efficiency of IV lidocaine in reducing the arterial hypertension associated with tracheal extubation [From the end of anesthesia to 5 minutes after tracheal extubation (At time 0, time 2 and time 3)]
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)
Determine the efficiency of IV lidocaine in reducing the increase in heart rate (HR) associated with tracheal extubation [From the end of anesthesia to 5 minutes after tracheal extubation (At time 0, time 2 and time 3)]
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)

Secondary Outcome Measures

Record the time elapsed from the end of anesthesia and the administration of lidocaine to extubation. [Intraoperative. From the end of anesthesia (time 0) to tracheal extubation (time 2)]
As a safety event. Record time between t0 and t2 (continuous, minutes)
Assess immediate POP sore throat [30 minutes after extubation]
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.

Other Outcome Measures

Monitor the adverse reactions (AR) that may occur after the administration of IV lidocaine and report them [24 hours after extubation]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).