The Effect of Intravenous Lidocaine on 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.
|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|
- 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
- = Stridor or partial laryngospasm
- = Complete Laryngospasm
- = Cyanosis
- 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
- = Mild cough (1-2 coughs)
- = Moderate cough (3-7 coughs)
- = Severe cough (more than 7 coughs)
|Study Start Date:||January 2012|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: 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||
1 mg/kg prior to extubation period. Injection of placebo will be immediately when inhalational agent (Desflurane) turned off.
Other Name: Normal Saline
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445847
|College of Medicine - King Khalid University Hospital|
|Riyadh, Saudi Arabia, 11472|
|Principal Investigator:||Khalid I Aljonaieh, Principal Investigator||King Saud University|