The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm

Laryngospasm Clinical Trial

Official title:

Effect of Intravenous Lidocaine on the Incidence of Post-extubation Laryngospasm: A Randomised Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01445847
• Other study ID #: E-11-491
• Status: Terminated
• Phase: N/A
• First received: September 29, 2011
• Last updated: January 1, 2015
• Start date: January 2012
• Est. completion date: April 2012

Study information

• Verified date: January 2015
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry for Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

• ß -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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Laryngismus
• Laryngospasm

Intervention

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:
• Placebo
1 mL/10 kg prior to extubation period. Injection of placebo will be immediately when inhalational agent (Desflurane) is discontinued.

Locations

Country	Name	City	State
Saudi Arabia	College of Medicine - King Saud University Medical City	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Laryngospasm Postoperatively	There were 4 scores of laryngospasm: 0 = No Laryngospasm; = Stridor or partial laryngospasm; = Complete Laryngospasm; = Cyanosis	within first 15 minutes post-dose	Yes

External Links

•   King Saud University
•   Ministry of Higher Education