EEG Characteristics of Different Sedation Depths in Neurosurgery Patients

Completed

• Conditions: Electroencephalography
• Interventions: Other: OAA/S=1; Other: OAA/S=3; Other: OAA/S=5

• Registration Number: NCT04365777
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-04-25
• Study First Posted: 2020-04-28
• Study Start: 2020-06-18
• Primary Completion: 2021-11-05
• Study Completion: 2021-11-05
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unconsciousness State	OAA/S=1	OAA/S=1
Sedation State	OAA/S=3	OAA/S=3
Awake State	OAA/S=5	OAA/S=5

Primary Outcome Measures

Name	Time	Method
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 sedation	The 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.

Trial Locations

Locations (2)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China

Beijing TianTan Hospital; 🇨🇳 Beijing, China