Laryngeal Reflex Study Under Propofol Anesthesia: Effect of Intravenous Lidocaine

Laryngospasm Clinical Trial

— LR6  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222169
• Other study ID #: UKBB_ANA_LR 6
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2010
• Last updated: October 29, 2015
• Start date: September 2010
• Est. completion date: May 2012

Study information

• Verified date: October 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Months to 84 Months

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Laryngospasm

Intervention

Drug:
• NaCl 0,9%
Propofol 3micrgr/ml (TCI plasma concentration) and NaCl 0,9% 2min. and 10min. application

Locations

Country	Name	City	State
Switzerland	University children's hospital beider Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Erb

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of laryngospasm (defined as complete adduction of vocal cords and/or fals cords) with apnea lasting >10sec after laryngeal stimulation		10 min.	No