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The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm

This study has been terminated.
(Patient Safety Concerns)
Sponsor:
Information provided by (Responsible Party):
Khalid Ibrahim Aljonaieh, King Saud University
ClinicalTrials.gov Identifier:
NCT01445847
First received: September 29, 2011
Last updated: January 1, 2015
Last verified: January 2015
  Purpose

In the literature, we found no randomized clinical trials addressing the using of IV lidocaine as prophylaxis for postoperative laryngospasm among adults.

The aim of this study was to assess the effects of IV lidocaine on the incidence of postoperative laryngospasm of adults patients.


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, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Intravenous Lidocaine on the Incidence of Post-extubation Laryngospasm: A Randomised Controlled Trial

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 15 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


Enrollment: 400
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lidocaine
Lidocaine 1% was prepared in 10 mL syringe= 10 mg/mL, dosage was 1mg/kg, one bolus or 10 mL/kg, with range of 2mg could be added or missed. The maximum dose is 100 mg for patients with weight of more than 100
Drug: Lidocaine
1 mg/kg or 1 mL/10 kg prior to extubation period. Injection of Lidocaine will be immediately when inhalational agent (Desflurane) is discontinued.
Other Name: Xylocaine
Placebo Comparator: Placebo
Normal saline was prepared in 10 mL syringe, dosage was 1 mL/10 kg.
Other: Placebo
1 mL/10 kg prior to extubation period. Injection of placebo will be immediately when inhalational agent (Desflurane) is discontinued.
Other Name: Normal Saline

Detailed Description:

During anesthesia practice, one of the common complications of airway management is laryngospasm. The etiology of laryngospasm is unknown but may be due to insufficient depth of anesthesia during tracheal intubation, light plane of anesthesia during tracheal extubation, pain, or presence of airway irritant like laryngoscope blade, irritated volatile agent, suction catheter, surgical debris, mucus, blood, or other foreign body. Laryngospasm occurs in both genders and all ages. Incidence of laryngospasm was reported to the Australian incident monitoring study (AIMS) was 5% with of 22% of them without an attributable cause.

Currently, there is no proven prophylaxis for laryngospasm and the known treatments of laryngospasm are used post-occurrence. However, elimination of factors that lead to laryngospasm is the most indispensable item for reduction of its incidence.

Intravenous (IV) lidocaine interrupts nerve conduction by blocking sodium channels. Recent meta-analysis study showed that IV lidocaine was able to prevent laryngospasm in children. However, in the literature, we found no randomized clinical trials addressing the using of IV lidocaine as prophylaxis for postoperative laryngospasm among adults.

The aim of this study was to assess the effects of IV lidocaine on the incidence of postoperative laryngospasm of adults patients.

  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 Saud University Medical City
Riyadh, Saudi Arabia, 11472
Sponsors and Collaborators
King Saud University
Investigators
Principal Investigator: Khalid I Aljonaieh, Lecturer 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: January 1, 2015
Health Authority: Saudi Arabia: Ministry for Higher Education

Keywords provided by King Saud University:
Laryngospasm
Lidocaine

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

ClinicalTrials.gov processed this record on March 02, 2015