Lidocaine to Prevent Cough and Hemodynamic Changes in Tracheal Extubation

NCT03731429 | Unknown Phase 4

• 1 other identifier: 201824
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Lidocaine

Keywords

Cough; Sore throat; Hemodynamic changes; Extubation; Lidocaine; Double blind

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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 Outcomes (2)

• 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)

• Assess immediate POP sore throat

  30 minutes after extubation

Other Outcomes (1)

• Monitor the adverse reactions (AR) that may occur after the administration of IV lidocaine and report them

  24 hours after extubation

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

group that receives 0.9% saline solution

Drug: Saline Solution

Interventions

Lidocaine DRUG

prior to extubation

Also known as: GOBBI

Intervention

Saline Solution DRUG

Prior to extubation

Also known as: GOBBI

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Fernandez: lead

Study Sites (1)

Hospital Fernandez

Capital Federal, Buenos Aires, 1425, Argentina

RECRUITING

Related Publications (47)

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MeSH Terms

Conditions

Cough; Pharyngitis

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Santiago Ficcadenti, Doctor

  Hospital Fernandez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia De Estrada, Doctor

CONTACT

+5491151096340; sofiaestrada89@gmail.com

Fernando Sanchez Casco, Doctor

CONTACT

+5491158842153; fersanchezcasco92@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: This study was designed as a double-blind randomized controlled trial

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 6, 2018
• Study Start: April 5, 2019
• Primary Completion: September 19, 2020
• Study Completion: November 1, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)