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Sevoflurane and Laryngeal Reflex Responses in Pediatric Patients

Primary Purpose

Laryngospasm

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
sevoflurane
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laryngospasm focused on measuring Anesthesia, children, Larynx

Eligibility Criteria

25 Months - 84 Months (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 23, 2008
    Last Updated
    March 11, 2009
    Sponsor
    University Hospital, Basel, Switzerland
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    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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