The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm

King Saud University

Status: Terminated

Conditions: Laryngospasm

Treatments: Other: Placebo; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01445847

E-11-491

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

134 participants in 2 patient groups, including a placebo group

Lidocaine

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo