Study Stopped
Recruitment finished earlier, because all 40 patients enrolled
Sevoflurane and Laryngeal Reflex Responses in Pediatric Patients
Impact of High Concentrations of Sevoflurane on Laryngeal Reflex Responses in Pediatric Patients
2 other identifiers
interventional
40
0 countries
N/A
Brief Summary
To describe laryngeal and respiratory reflex responses after controlled laryngeal stimulation in pediatric patients anesthetized with sevoflurane and to compare the evoked responses at two levels of anesthesia. To determine whether laryngeal and respiratory reflex responses after controlled laryngeal stimulation are completely suppressed in subjects when anesthetized with a MACEI95 (EI = endotracheal intubation) sevoflurane Hypothesis: The incidence of apnea with laryngospasm evoked by laryngeal stimulation will be reduced by 20% (from 25% to 5%) when the end-tidal concentration of sevoflurane is increased from 2.5% (MAC50) to 4.7% (MACEI95)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2008
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
April 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedMarch 12, 2009
March 1, 2009
6 months
January 23, 2008
March 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurence of laryngospasm (defined as complete closure of the vocal or false cords with apnea lasting >10sec) after laryngeal stimulation
5min
Study Arms (1)
1
EXPERIMENTALInterventions
sevoflurane 2.5% versus 4.7% (inhaled concentration) 10min each
Eligibility Criteria
You may qualify if:
- ASA I + II
- Elective intervention under general anesthesia
You may not qualify if:
- Reactive airway disease
- Respiratory tract infection (previous 2 weeks)
- Malignant hyperthermia
- Neuromuscular disease
- Cardiac disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Oberer C, von Ungern-Sternberg BS, Frei FJ, Erb TO. Respiratory reflex responses of the larynx differ between sevoflurane and propofol in pediatric patients. Anesthesiology. 2005 Dec;103(6):1142-8. doi: 10.1097/00000542-200512000-00007.
PMID: 16306725BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas O Erb, MD
Universitiy children's hospital Basel
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 23, 2008
First Posted
April 23, 2008
Study Start
February 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
March 12, 2009
Record last verified: 2009-03