AnesthesiaNCT04188782
Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure
An observational study of Anesthesia and Tolerance, run by University of Chile at 2 sites in Chile.
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. Read more about this study
- Who is it for?
- Ages 10 months to 12 years
- Conditions the study is for
- Anesthesia, Tolerance
- What is being tested?
- Sevoflurane
- How many people
- 24 participants
- Where
- 2 sitesChile
- Study dates
- 20 Nov 2019to 22 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 months to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: All consecutive pediatric patients schedule for radiotherapy treatment under general anesthesia.
Who may be able to join
- Patients undergoing radiotherapy
- Requiring general anesthesia
Who cannot join
- Previous Radiotherapy
- Malignant Hyperthermia history
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Instituto Nacional del Cancer
Santiago, Santiago Metropolitan, 7563215
Centro de Investigacion Clinica Avanzada
Santiago
About this study
Official title: Evaluation of the Development of Tolerance to Sevoflurane in Children Undergoing Repeated Anesthesia Exposure
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).
Read the 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
- Being tested
- Sevoflurane
- Keywords
- Anesthesia, Electroencephalogram, Spectral analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Describe how a reiterative anesthesia exposure could induce tolerance to the anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Theta power in the EEG spectrum under anesthesia
Theta power obtained from the EEG signal, with the patient under general anesthesia
Measured: Last session of radiotherapy (compare to first session) - Up to 6 weeks
Secondary outcomes (3)
Time to Laryngeal Mask insertion
The time in seconds between the induction beginning and the correct laryngeal mask placement
Measured: Last session of radiotherapy (compare to first session) - Up to 6 weeks
Alpha power in the EEG spectrum under anesthesia
Alpha power obtained from the EEG signal, with the patient under general
Measured: Last session of radiotherapy (compare to first session) - Up to 6 weeks
Coherence
Coherence between frontal electrodes in bands of the spectrum
Measured: Last session of radiotherapy (compare to first session) - Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start20 Nov 2019
- Primary completion20 Aug 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Gutiérrez, University of Chile
- Investigators
- Antonello Penna, MD PhD, Principal investigator, University of ChileJose I Egaña, MD PhD, Principal investigator, University of ChileFelipe Maldonado, Md MSc, Principal investigator, University of ChileRodrigo Gutierrez, MD PhD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188782
- Sponsor's protocol ID
- 0362019
- Status last verified
- Oct 2021
- First submitted
- 3 Dec 2019
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14739796
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Development of Tolerance to Sevoflurane in Children Undergoing Repeated Anesthesia Exposure
- ClinicalTrials.gov ID
- NCT04188782
- Acronym / sponsor ID
- 0362019
- Conditions
- Anesthesia, Tolerance
- Keywords
- Anesthesia, Electroencephalogram, Spectral analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients undergoing radiotherapy | – | Drug: SevofluranePediatric 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 |
Who may qualify
- Ages
- 10 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All consecutive pediatric patients schedule for radiotherapy treatment under general anesthesia.
Key inclusion criteria (2 listed)
- Patients undergoing radiotherapy
- Requiring general anesthesia
Key exclusion criteria (2 listed)
- Previous Radiotherapy
- Malignant Hyperthermia history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneDescribe how a reiterative anesthesia exposure could induce tolerance to the anesthetic. | Drug | Pediatric patients undergoing radiotherapy |
Primary outcome
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
3 secondary outcomes
Time to Laryngeal Mask insertion
Time frame: Last session of radiotherapy (compare to first session) - Up to 6 weeks
Alpha power in the EEG spectrum under anesthesia
Time frame: Last session of radiotherapy (compare to first session) - Up to 6 weeks
Coherence
Time frame: Last session of radiotherapy (compare to first session) - Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Background: PubMed 14739796Keidan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonello Penna, MD PhD principal investigator
University of Chile
Jose I Egaña, MD PhD principal investigator
University of Chile
Felipe Maldonado, Md MSc principal investigator
University of Chile
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Tolerance, run by University of Chile at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Theta power in the EEG spectrum under anesthesia (time frame: Last session of radiotherapy (compare to first session) - Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04188782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.