Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure

NCT04188782 | Completed FDA Drug

• 1 other identifier: 0362019
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 2

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).

Conditions

Anesthesia; Tolerance

Keywords

Anesthesia; Electroencephalogram; Spectral analysis

Outcome Measures

Primary Outcomes (1)

• Theta power in the EEG spectrum under anesthesia

  Theta power obtained from the EEG signal, with the patient under general anesthesia

  Last session of radiotherapy (compare to first session) - Up to 6 weeks

Secondary Outcomes (3)

• Time to Laryngeal Mask insertion

  Last session of radiotherapy (compare to first session) - Up to 6 weeks

• Alpha power in the EEG spectrum under anesthesia

  Last session of radiotherapy (compare to first session) - Up to 6 weeks

• Coherence

  Last session of radiotherapy (compare to first session) - Up to 6 weeks

Study Arms (1)

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

Interventions

Sevoflurane DRUG

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

Pediatric patients undergoing radiotherapy

Eligibility Criteria

• Age: 10 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive pediatric patients schedule for radiotherapy treatment under general anesthesia.

You may qualify if:

• Patients undergoing radiotherapy
• Requiring general anesthesia

You may not qualify if:

• Previous Radiotherapy
• Malignant Hyperthermia history

Sponsors & Collaborators

• University of Chile: lead

Study Sites (2)

Instituto Nacional del Cancer

Santiago, Santiago Metropolitan, 7563215, Chile

Location

Centro de Investigacion Clinica Avanzada

Santiago, Chile

Location

Related Publications (1)

• 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.

  PMID: 14739796 BACKGROUND

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 6, 2019
• Study Start: November 20, 2019
• Primary Completion: August 20, 2021
• Study Completion: September 22, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)