EEG Characteristics of Different Sedation Depths in Neurosurgery Patients

NCT ID: NCT04365777

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-18
• Study Completion Date: 2021-11-05

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.

Conditions

Electroencephalography

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Awake State

OAA/S=5

OAA/S=5

Intervention Type: OTHER

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

OAA/S=3

Intervention Type: OTHER

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

OAA/S=1

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruquan Han

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Beijing TianTan Hospital

Beijing, , China

Countries

China

Other Identifiers

ChiECRCT20200002

Identifier Type: -

Identifier Source: org_study_id