The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm

This study has been completed.
Sponsor:
Collaborator:
Albany College of Pharmacy and Health Sciences
Information provided by (Responsible Party):
Khalid Ibrahim Aljonaieh, King Saud University
ClinicalTrials.gov Identifier:
NCT01445847
First received: September 29, 2011
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to evaluate the effects of intravenous Lidocaine on post-extubation laryngospasm without the present of confounders.


Condition Intervention
Laryngospasm
Drug: Lidocaine
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Intravenous Lidocaine on the Incidence of Post-extubation Laryngospasm

Resource links provided by NLM:


Further study details as provided by King Saud University:

Primary Outcome Measures:
  • Number of Patients With Laryngospasm Postoperatively [ Time Frame: within first 5 minutes post‐dose ] [ Designated as safety issue: Yes ]

    There were 4 scores of laryngospasm:

    0 = No Laryngospasm

    1. = Stridor or partial laryngospasm
    2. = Complete Laryngospasm
    3. = Cyanosis


Secondary Outcome Measures:
  • Number of Patients With Incidence of Cough Postoperatively [ Time Frame: within first 5 minutes post‐dose ] [ Designated as safety issue: Yes ]

    There were 4 scores of cough:

    0 = No cough

    1. = Mild cough (1-2 coughs)
    2. = Moderate cough (3-7 coughs)
    3. = Severe cough (more than 7 coughs)


Enrollment: 99
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lidocaine Drug: Lidocaine
1 mg/kg prior to extubation period. Injection of Lidocaine will be immediately when inhalational agent (Desflurane) turned off.
Other Name: Xylocaine
Placebo Comparator: Placebo Other: Placebo
1 mg/kg prior to extubation period. Injection of placebo will be immediately when inhalational agent (Desflurane) turned off.
Other Name: Normal Saline

Detailed Description:

Laryngospasm is one of major complication with the incidence of 27.6/1000 in children compare to the incidence of 8.6/1000 in adult. Most common reason cause laryngospasm is due to present of foreign materials or substances which may irritate airway mucosa at insufficient depth of anesthesia.

Cough reflexes can be depressed by intravenous Lidocaine in dose-dependent fashion. The mechanism by which Lidocaine blocks the laryngospasm reflex arc may be due to a central interruption of the reflex pathway.

Three clinical trials studied the effect of intravenous Lidocaine on post-extubation laryngospasm. Two of them support that intravenous Lidocaine decreases the incidence of post-extubation laryngospasm and the 3rd one concluded that intravenous Lidocaine has no effect on the incidence of postextubation laryngospasm. All those clinical trials had confounders which may affect the results of their studies. The "No Touch" study showed no incidence of laryngospasm without pharmacology intervention.

This study will evaluate the effect of intravenous Lidocaine without the present of the confounders on post-extubation laryngospasm. If the hypothesis (use of intravenous Lidocaine combined with non-touch technique will prevent the incidence of laryngospasm post-extubation compared to use of non-touch technique alone) is true, intravenous Lidocaine should be given as a standard prior to extubation period which will prevent any kind of injury caused by laryngospasm.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesia score are I or II
  • Undergo for laparoscopic cholecystectomy

Exclusion Criteria:

  • Patient's refusal
  • History of upper respiratory tract infection (URTI) within 2 weeks
  • Persistent type of hyper-reactive airway or asthma
  • History of airway surgery
  • History of gastro-esophageal reflex disease (GERD)
  • Currently receiving sedating or analgesic medication
  • Currently receiving the following medications:

    • Fluvoxamine
    • Erythromycin and Itraconazole
    • β -blocker or Cimetidine
  • History of Lidocaine Allergy
  • History of epilepsy disorder
  • Pregnant or breastfeeding women
  • History of Heavy Smoking ( a smoker with a daily cigarettes consumption of more than 20 pieces
  • History of increased salivation by a disease or medication
  • History of difficult intubation
  • Two or more attempts of intubation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445847

Locations
Saudi Arabia
College of Medicine - King Khalid University Hospital
Riyadh, Saudi Arabia, 11472
Sponsors and Collaborators
King Saud University
Albany College of Pharmacy and Health Sciences
Investigators
Principal Investigator: Khalid I Aljonaieh, Principal Investigator King Saud University
  More Information

Additional Information:
No publications provided

Responsible Party: Khalid Ibrahim Aljonaieh, Principal Investigator, King Saud University
ClinicalTrials.gov Identifier: NCT01445847     History of Changes
Other Study ID Numbers: E-11-491
Study First Received: September 29, 2011
Results First Received: June 11, 2012
Last Updated: July 11, 2012
Health Authority: Saudi Arabia: Ministry for Higher Education

Keywords provided by King Saud University:
Laryngospasm
Lidocaine

Additional relevant MeSH terms:
Laryngismus
Vocal Cord Dysfunction
Laryngeal Diseases
Respiratory Tract Diseases
Respiration Disorders
Otorhinolaryngologic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014