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Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure

Evaluation of the Development of Tolerance to Sevoflurane in Children Undergoing Repeated Anesthesia Exposure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04188782
Enrollment
24
Registered
2019-12-06
Start date
2019-11-20
Completion date
2021-09-22
Last updated
2021-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Tolerance

Keywords

Anesthesia, Electroencephalogram, Spectral analysis

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

Interventions

DRUGSevoflurane

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

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Months to 12 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing radiotherapy * Requiring general anesthesia

Exclusion criteria

* Previous Radiotherapy * Malignant Hyperthermia history

Design outcomes

Primary

MeasureTime frameDescription
Theta power in the EEG spectrum under anesthesiaLast session of radiotherapy (compare to first session) - Up to 6 weeksTheta power obtained from the EEG signal, with the patient under general anesthesia

Secondary

MeasureTime frameDescription
Time to Laryngeal Mask insertionLast session of radiotherapy (compare to first session) - Up to 6 weeksThe time in seconds between the induction beginning and the correct laryngeal mask placement
Alpha power in the EEG spectrum under anesthesiaLast session of radiotherapy (compare to first session) - Up to 6 weeksAlpha power obtained from the EEG signal, with the patient under general
CoherenceLast session of radiotherapy (compare to first session) - Up to 6 weeksCoherence between frontal electrodes in bands of the spectrum

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026