Remifentanil and Laryngeal Reflex Responses in Pediatric Patients With URI
Impact of Remifentanil Administration on Laryngeal Reflex Responses in Pediatric Patients With Upper Respiratory Anesthetized With Propofol
2 other identifiers
interventional
62
1 country
1
Brief Summary
To describe respiratory and laryngeal responses to laryngeal stimulation during propofol anesthesia in children with upper airway infections. To determine whether the co-administration of remifentanil blunts these reflex responses. To test whether the co-administration of remifentanil results in a significant reduction of apnea with laryngospasm in these patients. Hypotheses: I: In children with a URI undergoing anesthesia with propofol, the incidence of apnea and laryngospasm after controlled stimulation is expected to occur 2.5 times more frequently than in children without URI (20 vs. 8%). II: The incidence of apnea and laryngospasm is diminished after administration of remifentanil.
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 Jan 2008
Longer than P75 for phase_4
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
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 25, 2008
CompletedFirst Posted
Study publicly available on registry
February 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedOctober 30, 2015
October 1, 2015
4.8 years
January 25, 2008
October 29, 2015
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
OTHERLarynx assessment under stimulation
Interventions
propofol 3micrgr/ml (TCI plasma concentration Kataria model) versus propofol 3micrgr/ml and remifentanil 0.05microgr/kg/min
Eligibility Criteria
You may qualify if:
- ASA I + II
- elective intervention under general anesthesia
- acute upper respiratory tract infection
You may not qualify if:
- chronic respiratory tract infection
- fever \>38,3° celsius
- productive cough
- neuromuscular disease
- malignant hyperthermia
- cardiac disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas Erblead
Study Sites (1)
University children's hospital
Basel, 4058, Switzerland
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
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof.Dr. Thomas Erb
Study Record Dates
First Submitted
January 25, 2008
First Posted
February 8, 2008
Study Start
January 1, 2008
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
October 30, 2015
Record last verified: 2015-10