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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

September 29, 2011
January 1, 2015
January 2012
April 2012   (final data collection date for primary outcome measure)
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
Number of Patients With Laryngospasm Postoperatively [ Time Frame: within first hour post‐dose ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01445847 on ClinicalTrials.gov Archive Site
Not Provided
  • Number of patients had incidence of nausea and vomiting postoperatively [ Time Frame: 0, 1, 2 hours post‐dose ] [ Designated as safety issue: Yes ]
  • Number of Patients With Incidence of Cough Postoperatively [ Time Frame: within first hour post‐dose ] [ Designated as safety issue: Yes ]
  • Change in pain severity postoperatively [ Time Frame: 0, 1, 2 hours post‐dose ] [ Designated as safety issue: Yes ]
  • Number of patients with incidence of aggressive behavior postoperatively [ Time Frame: 0,1,2 hours post‐dose ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm
Effect of Intravenous Lidocaine on the Incidence of Post-extubation Laryngospasm: A Randomised Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Laryngospasm
  • 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
  • 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
  • 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
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Placebo
    Normal saline was prepared in 10 mL syringe, dosage was 1 mL/10 kg.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
400
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia
 
NCT01445847
E-11-491
Yes
Not Provided
Not Provided
Khalid Ibrahim Aljonaieh, King Saud University
King Saud University
Not Provided
Principal Investigator: Khalid I Aljonaieh, Lecturer King Saud University
King Saud University
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP