Laryngeal Reflex Study Under Propofol Anesthesia: Effect of Intravenous Lidocaine (LR6)

Impact of Intravenous Lidocaine on Laryngeal Reflex Responses in Pediatric Patients Anesthetized With Propofol

To describe respiratory and laryngeal responses to laryngeal stimulation during propofol anesthesia in children. To determine whether the co-administration of lidocaine blunts these reflex responses. The outcome of primary interest is the reflex laryngospasm.

Hypotheses:

I: The severity of laryngospasm evoked by laryngeal stimulation is reduced 2 min. after iv. administration on 2mg/kg lidocaine in pediatric patients anesthetized with propofol (3mcg/ml).

II:The incidence of laryngospasm elicited by controlled stimulation 10min. after iv. administration of lidocaine is equivalent to the response before the administration of lidocaine.

Study Overview

• Status: Completed
• Conditions: Laryngospasm
• Intervention / Treatment: Drug: NaCl 0,9%

Detailed Description

Based on our previous work assessing the laryngeal reflex responses in children, the use of propofol appears to be promising regarding a low incidence of laryngospasm. Compared with a sevoflurane-based anesthesia, the incidence was found to be significantly lower, but there is a high incidence of other reflex responses, such as coughing and expiration reflexes. The use of lidocaine has been advocated to reduce the incidence of laryngospasm in anesthetized children. However, based on clinical studies its effectiveness in the prevention or attenuation of laryngospasm is controversial.

In a previous work using a established stimulation model (stimulating the laryngeal mucosa with a small amount of distilled water under direct fiberbronchoscopic observation), we observed a risk reduction of 60% of laryngospasm 2min. after the application of 2mg/kg bolus of lidocaine. This effect had already diminished after 10 min.

The laryngeal reflex responses differ largely in children anesthetized with either inhalational anesthetics or with propofol. The impact iv administered lidocaine on laryngeal and respiratory reflex responses in children anesthetized with propofol has not been assessed, although this combination might result in a profound suppression of laryngeal reflex responses.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University children's hospital beider Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 25 - 84 months
• gender: female / male
• elective surgery or diagnostic procedure requiring general anesthesia

Exclusion Criteria:

• respiratory infection within the last 2 weeks
• reactive airway disease under therapy
• cardiovascular disease
• neuromuscular disease
• positive family history of malignant hyperthermia
• known hypersensitivity to the investigational medical product
• Participation in another study
• Inability of the parents to read and understand the participant's information

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: larynx assessment under stimulation	Drug: NaCl 0,9%; Propofol 3micrgr/ml (TCI plasma concentration) and NaCl 0,9% 2min. and 10min. application; Other Names: Propofol; Disoprivan; Recofol; Natriumchlorid
Placebo Comparator: Larynx assessment under stimulation	Drug: NaCl 0,9%; Propofol 3micrgr/ml (TCI plasma concentration) and NaCl 0,9% 2min. and 10min. application; Other Names: Propofol; Disoprivan; Recofol; Natriumchlorid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurence of laryngospasm (defined as complete adduction of vocal cords and/or fals cords) with apnea lasting >10sec after laryngeal stimulation	10 min.

Collaborators and Investigators

• Sponsor: Thomas Erb
• Investigators: Principal Investigator: Thomas O Erb, Professor MD, University children's hospital beider Basel

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: September 23, 2010
• First Submitted That Met QC Criteria: October 14, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Estimate): October 30, 2015
• Last Update Submitted That Met QC Criteria: October 29, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Children; Anesthesia; Larynx
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Laryngeal Diseases; Vocal Cord Dysfunction; Laryngismus; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: UKBB_ANA_LR 6