Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188782
• Other study ID #: 0362019
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia
• Tolerance

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