Laryngeal Reflex Study Under Propofol Anesthesia: Effect of Intravenous Lidocaine

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Erb
• Treatments: Lidocaine; Propofol

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