Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure

• Sponsor: University of Chile (Other)
• Overall Status: Completed
• CT.gov ID: NCT04188782
• Collaborator: (none)
• Enrollment: 24
• Locations: 2
• Actual Duration (Months): 22.1
• Patients Per Site: 12
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	Phase
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

Study Design

• Study Type: Observational
• Actual Enrollment: 24 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: Nov 20, 2019
• Actual Primary Completion Date: Aug 20, 2021
• Actual Study Completion Date: Sep 22, 2021

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

1. Theta power in the EEG spectrum under anesthesia [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 [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 [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 [Last session of radiotherapy (compare to first session) - Up to 6 weeks]

   Coherence between frontal electrodes in bands of the spectrum

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Months to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing radiotherapy

• Requiring general anesthesia

Exclusion Criteria:

• Previous Radiotherapy

• Malignant Hyperthermia history

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional del Cancer	Santiago	Metropolitana	Chile	7563215
2	Centro de Investigacion Clinica Avanzada	Santiago		Chile

Sponsors and Collaborators

• University of Chile

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Rodrigo Gutiérrez, Principal Investigator, University of Chile
• ClinicalTrials.gov Identifier: NCT04188782
• Other Study ID Numbers: 0362019
• First Posted: Dec 6, 2019
• Last Update Posted: Oct 7, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Principal Investigator, University of Chile: Anesthesia; Electroencephalogram; Spectral analysis
• Additional relevant MeSH terms: Sevoflurane

Study Results

No Results Posted as of Oct 7, 2021