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

September 29, 2011
July 11, 2012
January 2012
May 2012   (final data collection date for primary outcome measure)
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
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
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)
  • 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

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Laryngospasm
  • Drug: Lidocaine
    1 mg/kg prior to extubation period. Injection of Lidocaine will be immediately when inhalational agent (Desflurane) turned off.
    Other Name: Xylocaine
  • 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
  • Active Comparator: Lidocaine
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Placebo
    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.
 
Completed
99
May 2012
May 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
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia
 
NCT01445847
E-11-491
Yes
Khalid Ibrahim Aljonaieh, King Saud University
King Saud University
Albany College of Pharmacy and Health Sciences
Principal Investigator: Khalid I Aljonaieh, Principal Investigator King Saud University
King Saud University
July 2012

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