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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04188782
Other study ID # 0362019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 20, 2019
Est. completion date September 22, 2021

Study information

Verified date October 2021
Source University of Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Description:

The purpose of this study is to evaluate the development of tolerance to sevoflurane in children undergoing repeated drug exposure. We will evaluate the development of tolerance in two ways: Clinical: as the time needed to perform the inhalation induction, with a standardized protocol. Electroencephalographic: we will record every 3 sessions the electroencephalographic activity of the patients. We will perform classical spectral analysis, and coherence analysis as well. This observational study will be mainly exploratory since there are no other previous report in this topic


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sevoflurane
Describe how a reiterative anesthesia exposure could induce tolerance to the anesthetic.

Locations

Country Name City State
Chile Centro de Investigacion Clinica Avanzada Santiago
Chile Instituto Nacional del Cancer Santiago Metropolitana

Sponsors (1)

Lead Sponsor Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (1)

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

Outcome

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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