The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm
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Purpose
The purpose of this study is to evaluate the effects of intravenous Lidocaine on post-extubation laryngospasm without the present of confounders.
| 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) 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)
| Enrollment: | 99 |
| Study Start Date: | January 2012 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Lidocaine |
Drug: 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 |
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Saudi Arabia | |
| College of Medicine - King Khalid University Hospital | |
| Riyadh, Saudi Arabia, 11472 | |
| Principal Investigator: | Khalid I Aljonaieh, Principal Investigator | 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: | July 11, 2012 |
| Health Authority: | Saudi Arabia: Ministry for Higher Education |
Keywords provided by King Saud University:
|
Laryngospasm Lidocaine |
Additional relevant MeSH terms:
|
Laryngismus Laryngeal Diseases Respiratory Tract Diseases Respiration Disorders Otorhinolaryngologic Diseases Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013