Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure

NCT ID: NCT04188782

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2021-09-22

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

Conditions

Anesthesia; Tolerance

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric patients undergoing radiotherapy

Pediatric patients undergoing general anesthesia for radiotherapy treatment. General anesthesia will be accomplished exclusively by the administration of sevoflurane.

The inhalatory induction will be performed with sevofluorane at 8% with O2 4Lt/min. The maintenance will be with sevofluorane at an end tidal of 2.5% with 1Lt/min of O2.

The EEG will be obtain with SedLine monitor

Sevoflurane

Intervention Type: DRUG

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

Interventions

Sevoflurane

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients undergoing radiotherapy
• Requiring general anesthesia

Exclusion Criteria

• Previous Radiotherapy
• Malignant Hyperthermia history

• Minimum Eligible Age: 10 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Gutiérrez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonello Penna, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Jose I Egaña, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Felipe Maldonado, Md MSc

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Rodrigo Gutierrez, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Locations

Instituto Nacional del Cancer

Santiago, Santiago Metropolitan, Chile

Centro de Investigacion Clinica Avanzada

Santiago, , Chile

Countries

Chile

References

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.

Reference Type: BACKGROUND

PMID: 14739796 (View on PubMed)

Other Identifiers

0362019

Identifier Type: -

Identifier Source: org_study_id