Laryngeal Reflex Study Under Propofol Anesthesia: Effect of Intravenous Lidocaine

NCT ID: NCT01222169

Last Updated: 2015-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-05-31

Brief 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.

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.

Conditions

Laryngospasm

Study Design

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

Study Groups

larynx assessment under stimulation

Group Type: EXPERIMENTAL

NaCl 0,9%

Intervention Type: DRUG

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

Larynx assessment under stimulation

Group Type: PLACEBO_COMPARATOR

NaCl 0,9%

Intervention Type: DRUG

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

Interventions

NaCl 0,9%

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

Intervention Type: DRUG

Other Intervention Names

Propofol; Disoprivan; Recofol; Natriumchlorid

Eligibility Criteria

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

• Minimum Eligible Age: 25 Months
• Maximum Eligible Age: 84 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Erb

OTHER

Sponsor Role: lead

Responsible Party

Thomas Erb

Prof. Dr. Thomas O. Erb

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas O Erb, Professor MD

Role: PRINCIPAL_INVESTIGATOR

University children's hospital beider Basel

Locations

University children's hospital beider Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

UKBB_ANA_LR 6

Identifier Type: -

Identifier Source: org_study_id