ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01445847
Recruitment Status : Terminated (Patient Safety Concerns)
First Posted : October 4, 2011
Results First Posted : July 12, 2012
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Khalid Ibrahim Aljonaieh, King Saud University

Brief Summary:

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 or disease Intervention/treatment Phase
Laryngospasm Drug: Lidocaine Other: Placebo Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Intravenous Lidocaine on the Incidence of Post-extubation Laryngospasm: A Randomised Controlled Trial
Study Start Date : January 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of Patients With Laryngospasm Postoperatively [ Time Frame: within first 15 minutes post‐dose ]

    There were 4 scores of laryngospasm:

    0 = No Laryngospasm

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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Khalid Ibrahim Aljonaieh, Principal Investigator, King Saud University
ClinicalTrials.gov Identifier: NCT01445847     History of Changes
Other Study ID Numbers: E-11-491
First Posted: October 4, 2011    Key Record Dates
Results First Posted: July 12, 2012
Last Update Posted: May 22, 2017
Last Verified: April 2017

Keywords provided by Khalid Ibrahim Aljonaieh, 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
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action