EEG Characteristics of Different Sedation Depths in Neurosurgery Patients

NCT04365777 | Completed

• 1 other identifier: ChiECRCT20200002
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Awake State

OAA/S=5

Other: OAA/S=5

Sedation State

OAA/S=3

Other: OAA/S=3

Unconsciousness State

OAA/S=1

Other: OAA/S=1

Interventions

OAA/S=5 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.

Awake State

OAA/S=3 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.

Sedation State

OAA/S=1 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.

Unconsciousness State

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (2)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Beijing TianTan Hospital

Beijing, 100070, China

Location

Study Design

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

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: April 28, 2020
• Study Start: June 18, 2020
• Primary Completion: November 5, 2021
• Study Completion: November 5, 2021
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)