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Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure

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ClinicalTrials.gov Identifier: NCT04188782
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Rodrigo Gutiérrez, University of Chile

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).


Condition or disease Intervention/treatment
Anesthesia Tolerance Drug: Sevoflurane

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

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Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Development of Tolerance to Sevoflurane in Children Undergoing Repeated Anesthesia Exposure
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Group/Cohort Intervention/treatment
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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   10 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive pediatric patients schedule for radiotherapy treatment under general anesthesia.
Criteria

Inclusion Criteria:

  • Patients undergoing radiotherapy
  • Requiring general anesthesia

Exclusion Criteria:

  • Epilepsy
  • Malignant Hyperthermia history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188782


Contacts
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Contact: Rodrigo G Gutierrez, MD PhD 56995993665 rggutierrez1@gmail.com

Locations
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Chile
Instituto Nacional del Cancer Recruiting
Santiago, Metropolitana, Chile, 7563215
Contact: Rodrigo Gutierrez, MD    +56995993665    rggutierrez1@gmail.com   
Centro de Investigacion Clinica Avanzada Active, not recruiting
Santiago, Chile
Sponsors and Collaborators
University of Chile
Investigators
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Principal Investigator: Antonello Penna, MD PhD University of Chile
Principal Investigator: Jose I Egaña, MD PhD University of Chile
Principal Investigator: Felipe Maldonado, Md MSc University of Chile
Principal Investigator: Rodrigo Gutierrez, MD PhD University of Chile

Publications:
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Responsible Party: Rodrigo Gutiérrez, Principal Investigator, University of Chile
ClinicalTrials.gov Identifier: NCT04188782    
Other Study ID Numbers: 0362019
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rodrigo Gutiérrez, University of Chile:
Anesthesia
Electroencephalogram
Spectral analysis
Additional relevant MeSH terms:
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Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General