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Completed

NCT Number: NCT04188782

Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure

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).

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Key information

Conditions

Anesthesia Tolerance

Age range

10 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional del Cancer, Santiago, Santiago Metropolitan, Chile

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing radiotherapy
  • Requiring general anesthesia

Exclusion criteria

  • Previous Radiotherapy
  • Malignant Hyperthermia history

Treatment and study plan

Sevoflurane

Drug

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

Primary outcomes

  1. Theta power in the EEG spectrum under anesthesia

    Time frame: Last session of radiotherapy (compare to first session) - Up to 6 weeks

    Theta power obtained from the EEG signal, with the patient under general anesthesia

Secondary outcomes

  1. Time to Laryngeal Mask insertion

    Time frame: Last session of radiotherapy (compare to first session) - Up to 6 weeks

    The time in seconds between the induction beginning and the correct laryngeal mask placement

  2. Alpha power in the EEG spectrum under anesthesia

    Time frame: Last session of radiotherapy (compare to first session) - Up to 6 weeks

    Alpha power obtained from the EEG signal, with the patient under general

  3. Coherence

    Time frame: Last session of radiotherapy (compare to first session) - Up to 6 weeks

    Coherence between frontal electrodes in bands of the spectrum

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 6, 2019
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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