Clinical trial NCT01445847: The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm
Official title: Effect of Intravenous Lidocaine on the Incidence of Post-extubation Laryngospasm: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Laryngospasm
Keywords: Laryngospasm
Lidocaine
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2011-10-04
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Patients With Laryngospasm Postoperatively
timeFrame: within first 15 minutes post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: College of Medicine - King Saud University Medical City
Study officials:
affiliation: King Saud University
name: Khalid I Aljonaieh, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: