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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 23, 2010
CompletedFirst Posted
Study publicly available on registry
October 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedOctober 30, 2015
October 1, 2015
1.7 years
September 23, 2010
October 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurence of laryngospasm (defined as complete adduction of vocal cords and/or fals cords) with apnea lasting >10sec after laryngeal stimulation
10 min.
Study Arms (2)
larynx assessment under stimulation
EXPERIMENTALLarynx assessment under stimulation
PLACEBO COMPARATORInterventions
Propofol 3micrgr/ml (TCI plasma concentration) and NaCl 0,9% 2min. and 10min. application
Eligibility Criteria
You may qualify if:
- months
- gender: female / male
- elective surgery or diagnostic procedure requiring general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas Erblead
Study Sites (1)
University children's hospital beider Basel
Basel, 4031, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas O Erb, Professor MD
University children's hospital beider Basel
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. Thomas O. Erb
Study Record Dates
First Submitted
September 23, 2010
First Posted
October 18, 2010
Study Start
September 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
October 30, 2015
Record last verified: 2015-10