Sevoflurane and Laryngeal Reflex Responses in Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT00665418|
Recruitment Status : Terminated (Recruitment finished earlier, because all 40 patients enrolled)
First Posted : April 23, 2008
Last Update Posted : March 12, 2009
|Condition or disease||Intervention/treatment||Phase|
|Laryngospasm||Drug: sevoflurane||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of High Concentrations of Sevoflurane on Laryngeal Reflex Responses in Pediatric Patients|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
sevoflurane 2.5% versus 4.7% (inhaled concentration) 10min each
Other Name: Ultane
- Occurence of laryngospasm (defined as complete closure of the vocal or false cords with apnea lasting >10sec) after laryngeal stimulation [ Time Frame: 5min ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665418
|Principal Investigator:||Thomas O Erb, MD||Universitiy children's hospital Basel|