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EEG Characteristics of Different Sedation Depths in Neurosurgery Patients

EEG Characteristics of Different Sedation Depths in Patients With Supratentorial Glioma in Frontal Lobe

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04365777
Enrollment
42
Registered
2020-04-28
Start date
2020-06-18
Completion date
2021-11-05
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electroencephalography

Brief summary

Gliomas are the most common primary intracranial malignancy, and behavioral experiments in patients with supratentorial gliomas under sedation have shown potential neurological abnormalities; however, these behavioral experiments are susceptible to external influences. Therefore, more objective evidence is needed to support and extend the existing conclusions. The purpose of this study is to compare the EEG signatures (such as the EEG signal power) at various levels of anesthetics induced sedation in patients with supratentorial glioma in frontal lobe and in patients without intracranial-occupying lesion.

Interventions

OTHEROAA/S=5

Prior to anesthesia induciton, EEG signatures will be recorded at Observer's Assessment of Alertness/Sedation (OAA/S) score of 5 (awake, eye-close state) for few minutes.

OTHEROAA/S=3

Given sedative anesthetics (propofol, midazolam or dexmetomidine), EEG signatures will be recorded after reaching steady state of OAA/S=3 (responds only after name called loudly and/or repeatedly) for few minutes.

OTHEROAA/S=1

Increasing drug concentration, EEG signatures will be recorded after reaching steady state of OAA/S=1 (does not respond to noxious stimuli) for few minutes.

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Patients with supratentorial glioma in right frontal lobe, and patients requiring general anesthesia without intracranial-occupying lesion; 2. Aged 18-60 years; 3. ASA I to II; 4. All those who sign the informed consent form.

Exclusion criteria

1. Obese patients, BMI\>30kg/m2; 2. Patients with Mallampati class III to IV airway anatomy; 3. Combined with other neurological or psychiatric diseases; 4. Combined with disturbance of consciousness; 5. Previous intracranial surgery; 6. Known or suspected cardiac dysfunction; 7. Allergic to intravenous general anesthetics; 8. Long-term history of analgesia, sedation and drug abuse.

Design outcomes

Primary

MeasureTime frameDescription
1. The time-frequency characteristics of EEG power changes at different sedation depths in neurosurgical patients.Prior to anesthesia induction, three minutes after reaching the target level of sedationThe EEG power will be calculated by raw signal at awake, eye-closed state and after reaching the steady-state sedation depths of OAA/S=3 and OAA/S=1.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026