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OpenTrials
Completed

NCT Number: NCT04365777

EEG Characteristics of Different Sedation Depths in Neurosurgery Patients

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.

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Key information

Conditions

Electroencephalography

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 1. The time-frequency characteristics of EEG power changes at different sedation depths in neurosurgical patients.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2020
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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