Anesthesia Clinical Trial
Official title:
Evaluation of the Development of Tolerance to Sevoflurane in Children Undergoing Repeated Anesthesia Exposure
Verified date | October 2021 |
Source | University of Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Deep sedation or general anesthesia is frequently required for infant that need radiotherapy to treat malignancies. As radiation therapy usually consist of several sessions, these patients are exposure to several consecutive anesthetic exposures (e.g. for some central nervous system tumors 30 sessions of radiotherapy are required). In our center, this 30-min anesthetic exposure are with sevoflurane. Considering that repeated daily exposure to such potent drugs, as general anesthetics, may induce tolerance, it is reasonable to explore whether this phenomenon is occurring in this population. The aim of this observational study was to determine if a repeated exposure to sevoflurane is associated with the development of clinical and electroencephalographic tolerance. We will enroll 16 pediatric patients, and we will measure the time needed to appropriately place the laryngeal mask (clinical effect) and we also will compare the electroencephalographic signal under anesthesia across the different sessions (electroencephalographic effect).
Status | Completed |
Enrollment | 24 |
Est. completion date | September 22, 2021 |
Est. primary completion date | August 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Months to 12 Years |
Eligibility | Inclusion Criteria: - Patients undergoing radiotherapy - Requiring general anesthesia Exclusion Criteria: - Previous Radiotherapy - Malignant Hyperthermia history |
Country | Name | City | State |
---|---|---|---|
Chile | Centro de Investigacion Clinica Avanzada | Santiago | |
Chile | Instituto Nacional del Cancer | Santiago | Metropolitana |
Lead Sponsor | Collaborator |
---|---|
University of Chile |
Chile,
Keidan I, Perel A, Shabtai EL, Pfeffer RM. Children undergoing repeated exposures for radiation therapy do not develop tolerance to propofol: clinical and bispectral index data. Anesthesiology. 2004 Feb;100(2):251-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Theta power in the EEG spectrum under anesthesia | Theta power obtained from the EEG signal, with the patient under general anesthesia | Last session of radiotherapy (compare to first session) - Up to 6 weeks | |
Secondary | Time to Laryngeal Mask insertion | The time in seconds between the induction beginning and the correct laryngeal mask placement | Last session of radiotherapy (compare to first session) - Up to 6 weeks | |
Secondary | Alpha power in the EEG spectrum under anesthesia | Alpha power obtained from the EEG signal, with the patient under general | Last session of radiotherapy (compare to first session) - Up to 6 weeks | |
Secondary | Coherence | Coherence between frontal electrodes in bands of the spectrum | Last session of radiotherapy (compare to first session) - Up to 6 weeks |
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