EEG Characteristics of Different Sedation Depths in Neurosurgery Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Electroencephalography
• Intervention / Treatment: Other: OAA/S=5; Other: OAA/S=3; Other: OAA/S=1

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100070
    • Beijing Tiantan Hospital
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged between 18 and 60 years with American Society of Anesthesiology status I or II who were scheduled to receive elective surgery under general anesthesia. Patients with supratentorial glioma in right frontal lobe diagnosed by magnetic resonance imaging were included in the glioma group while patients requiring general anesthesia without intracranial-occupying lesion were included in the control group.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Awake State; OAA/S=5	Other: OAA/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.
Sedation State; OAA/S=3	Other: OAA/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.
Unconsciousness State; OAA/S=1	Other: OAA/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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. The time-frequency characteristics of EEG power changes at different sedation depths in neurosurgical patients.	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.	Prior to anesthesia induction, three minutes after reaching the target level of sedation

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2020
• Primary Completion (ACTUAL): November 5, 2021
• Study Completion (ACTUAL): November 5, 2021

Study Registration Dates

• First Submitted: April 25, 2020
• First Submitted That Met QC Criteria: April 25, 2020
• First Posted (ACTUAL): April 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ChiECRCT20200002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No