Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04188782|
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : December 6, 2019
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|
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
|Study Type :||Observational|
|Estimated Enrollment :||16 participants|
|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|
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
Describe how a reiterative anesthesia exposure could induce tolerance to the anesthetic.
- 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
- 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
- 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
- Coherence [ Time Frame: Last session of radiotherapy (compare to first session) - Up to 6 weeks ]Coherence between frontal electrodes in bands of the spectrum
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
|Contact: Rodrigo G Gutierrez, MD PhDemail@example.com|
|Instituto Nacional del Cancer||Recruiting|
|Santiago, Metropolitana, Chile, 7563215|
|Contact: Rodrigo Gutierrez, MD +56995993665 firstname.lastname@example.org|
|Centro de Investigacion Clinica Avanzada||Active, not recruiting|
|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|