Full Text View
Tabular View
No Study Results Posted
Related Studies
Sevoflurane and Laryngeal Reflex Responses in Pediatric Patients
This study has been terminated.
( Recruitment finished earlier, because all 40 patients enrolled )
First Received: January 23, 2008   Last Updated: March 11, 2009   History of Changes
Sponsored by: University Hospital, Basel, Switzerland
Information provided by: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00665418
  Purpose

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)


Condition Intervention Phase
Laryngospasm
Drug: sevoflurane
Phase IV

Study Type: Interventional
Study Design: Prevention, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study
Official Title: Impact of High Concentrations of Sevoflurane on Laryngeal Reflex Responses in Pediatric Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Occurence of laryngospasm (defined as complete closure of the vocal or false cords with apnea lasting >10sec) after laryngeal stimulation [ Time Frame: 5min ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: sevoflurane
sevoflurane 2.5% versus 4.7% (inhaled concentration) 10min each

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.

  Eligibility

Ages Eligible for Study:   25 Months to 84 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665418

Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Thomas O Erb, MD Universitiy children's hospital Basel
  More Information

Publications:
Responsible Party: Department of Anesthesia ( Albert Urwyler MD )
Study ID Numbers: UNIBAS_UKBB_ANE_LR4, SNF_3200B0-109322
Study First Received: January 23, 2008
Last Updated: March 11, 2009
ClinicalTrials.gov Identifier: NCT00665418     History of Changes
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Anesthesia
children
Larynx

Study placed in the following topic categories:
Anesthetics, Inhalation
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Anesthetics, General
Respiration Disorders
Central Nervous System Depressants
Anesthetics
Platelet Aggregation Inhibitors
Laryngeal Diseases
Laryngismus
Sevoflurane

Additional relevant MeSH terms:
Otorhinolaryngologic Diseases
Physiological Effects of Drugs
Respiration Disorders
Hematologic Agents
Central Nervous System Depressants
Anesthetics
Pharmacologic Actions
Sevoflurane
Anesthetics, Inhalation
Respiratory Tract Diseases
Anesthetics, General
Therapeutic Uses
Platelet Aggregation Inhibitors
Laryngismus
Laryngeal Diseases
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009