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Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure

NCT04188782 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2021-10-07

No results posted yet for this study

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).

Conditions

  • Anesthesia
  • Tolerance

Interventions

DRUG

Sevoflurane

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

Sponsors & Collaborators

  • University of Chile

    lead OTHER

Principal Investigators

  • Antonello Penna, MD PhD · University of Chile

  • Jose I Egaña, MD PhD · University of Chile

  • Felipe Maldonado, Md MSc · University of Chile

  • Rodrigo Gutierrez, MD PhD · University of Chile

Eligibility

Min Age
10 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2021-08-20
Completion
2021-09-22
FDA Drug
Yes

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188782 on ClinicalTrials.gov