Clinical trial NCT04188782: Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure
Official title: Evaluation of the Development of Tolerance to Sevoflurane in Children Undergoing Repeated Anesthesia Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Tolerance
Keywords: Anesthesia
Electroencephalogram
Spectral analysis
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive pediatric patients schedule for radiotherapy treatment under general anesthesia.

Brief 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).

Detailed 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

Eligibility criteria: Inclusion Criteria:

* Patients undergoing radiotherapy
* Requiring general anesthesia

Exclusion Criteria:

* Previous Radiotherapy
* Malignant Hyperthermia history

Primary outcomes:
measure: Theta power in the EEG spectrum under anesthesia
timeFrame: Last session of radiotherapy (compare to first session) - Up to 6 weeks
Secondary outcomes:
measure: Time to Laryngeal Mask insertion
timeFrame: Last session of radiotherapy (compare to first session) - Up to 6 weeks
measure: Alpha power in the EEG spectrum under anesthesia
timeFrame: Last session of radiotherapy (compare to first session) - Up to 6 weeks
measure: Coherence
timeFrame: Last session of radiotherapy (compare to first session) - Up to 6 weeks
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Instituto Nacional del Cancer
state: Metropolitana
city: Santiago
country: Chile
facility: Centro de Investigacion Clinica Avanzada
Study officials:
affiliation: University of Chile
name: Antonello Penna, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Jose I Egaña, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Felipe Maldonado, Md MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Rodrigo Gutierrez, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/00000542-200402000-00011.