The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm

NCT ID: NCT01445847

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-04-30

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.

Conditions

Laryngospasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Lidocaine

Lidocaine 1% was prepared in 10 mL syringe= 10 mg/mL, dosage was 1mg/kg, one bolus or 10 mL/kg, with range of 2mg could be added or missed. The maximum dose is 100 mg for patients with weight of more than 100

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

1 mg/kg or 1 mL/10 kg prior to extubation period. Injection of Lidocaine will be immediately when inhalational agent (Desflurane) is discontinued.

Placebo

Normal saline was prepared in 10 mL syringe, dosage was 1 mL/10 kg.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Xylocaine; Normal Saline

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Khalid Ibrahim Aljonaieh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khalid I Aljonaieh, Lecturer

Role: PRINCIPAL_INVESTIGATOR

King Saud University

Locations

College of Medicine - King Saud University Medical City

Riyadh, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Related Links

http://ksu.edu.sa

King Saud University

Other Identifiers

E-11-491

Identifier Type: -

Identifier Source: org_study_id