Sevoflurane and Laryngeal Reflex Responses in Pediatric Patients
Primary Purpose
Laryngospasm
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
sevoflurane
Sponsored by
About this trial
This is an interventional prevention trial for Laryngospasm focused on measuring Anesthesia, children, Larynx
Eligibility Criteria
Inclusion Criteria:
- ASA I + II
- Elective intervention under general anesthesia
Exclusion Criteria:
- Reactive airway disease
- Respiratory tract infection (previous 2 weeks)
- Malignant hyperthermia
- Neuromuscular disease
- Cardiac disease
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Occurence of laryngospasm (defined as complete closure of the vocal or false cords with apnea lasting >10sec) after laryngeal stimulation
Secondary Outcome Measures
Full Information
NCT ID
NCT00665418
First Posted
January 23, 2008
Last Updated
March 11, 2009
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00665418
Brief Title
Sevoflurane and Laryngeal Reflex Responses in Pediatric Patients
Official Title
Impact of High Concentrations of Sevoflurane on Laryngeal Reflex Responses in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Terminated
Why Stopped
Recruitment finished earlier, because all 40 patients enrolled
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
Detailed Description
Induction of anesthesia inhaling sevoflurane is a very common practice in pediatric anesthesia.However, unwarranted exaggerated upper airway defensive reflexes that develop into apnea and laryngospasm with resultant hypoxemia is more common and also more severe.
Despite their obvious clinical significance, reflexes that involve the function of the upper airway are only minimally understood and information on such reflexes is scarce in anesthetized humans. Nonetheless, a model was developed by analyzing respiratory variables and endoscopic images after stimulating the laryngeal mucosa with a small amount of distilled water. Clinical experience suggests that laryngeal reflexes occur more frequently under light levels of anesthesia. However, in contrast to other inhalational agents such as halothan, available data for sevoflurane suggest that an inverse correlation of laryngeal responsiveness to depth of hypnosis or end-tidal concentrations of sevoflurane (in adults and children) is less obvious. However, in all previous studies assessing laryngeal reflex responses under sevoflurane only low concentrations of sevoflurane (range of 1.0 - 2.5 Vol%) were examined. This is an important limitation because in clinical practice higher concentrations of sevoflurane are used, especially during manipulation of the airway, while the risk of airway irritation is high. Thus, the proposed study aims to explore the question whether the occurrence of laryngospasm can be reliably suppressed when high concentrations of sevoflurane are used.
Based on results of experiments assessing conditions that facilitate tracheal intubation, it is clear, that increasing the end-tidal concentration of volatile agents obtunds airway reflexes. Regarding intubation conditions, the concept of MACEI 50% or 95% describes the minimum alveolar concentration (MAC) of a volatile anesthetic needed by 50 or 95% of the patients, respectively, to prevent all movement during and immediately after tracheal intubation. The proposed study aims to assess respiratory reflex responses at these levels of anesthesia by analyzing the respiratory variables and endoscopic images. The incidences of well-defined airway reflexes (cough reflex, spasmodic panting, expiration reflex, and apnea with laryngospasm, central apnea) will be examined. Apnea with laryngospasm will be of primary interest in our study and digital video analysis of the glottic opening will allow for a detailed analysis of laryngeal performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngospasm
Keywords
Anesthesia, children, Larynx
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Other Intervention Name(s)
Ultane
Intervention Description
sevoflurane 2.5% versus 4.7% (inhaled concentration) 10min each
Primary Outcome Measure Information:
Title
Occurence of laryngospasm (defined as complete closure of the vocal or false cords with apnea lasting >10sec) after laryngeal stimulation
Time Frame
5min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Months
Maximum Age & Unit of Time
84 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I + II
Elective intervention under general anesthesia
Exclusion Criteria:
Reactive airway disease
Respiratory tract infection (previous 2 weeks)
Malignant hyperthermia
Neuromuscular disease
Cardiac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas O Erb, MD
Organizational Affiliation
Universitiy children's hospital Basel
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
16306725
Citation
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.
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Sevoflurane and Laryngeal Reflex Responses in Pediatric Patients
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