ElectroencephalographyNCT04365777
EEG Characteristics of Different Sedation Depths in Neurosurgery Patients
An observational study of Electroencephalography, run by Beijing Tiantan Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Electroencephalography
- What is being tested?
- OAA/S=5, OAA/S=3 and OAA/S=1
- How many people
- 42 participants
- Where
- 2 sitesChina
- Study dates
- 18 Jun 2020to 5 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Beijing TianTan Hospital
Beijing, 100070
About this study
Official title: 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.
- Conditions
- Electroencephalography
- Being tested
- OAA/S=5, OAA/S=3, OAA/S=1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OAA/S=5Other
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=3Other
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=1Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Awake State | OAA/S=5 Receives: Other: OAA/S=5 | |
| Sedation State | OAA/S=3 Receives: Other: OAA/S=3 | |
| Unconsciousness State | OAA/S=1 Receives: Other: OAA/S=1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prior to anesthesia induction, three minutes after reaching the target level of sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start18 Jun 2020
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroencephalographyStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365777
- Sponsor's protocol ID
- ChiECRCT20200002
- Status last verified
- Feb 2023
- First submitted
- 25 Apr 2020
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Characteristics of Different Sedation Depths in Patients With Supratentorial Glioma in Frontal Lobe
- ClinicalTrials.gov ID
- NCT04365777
- Acronym / sponsor ID
- ChiECRCT20200002
- Conditions
- Electroencephalography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Awake State | – | Other: OAA/S=5OAA/S=5 |
| Sedation State | – | Other: OAA/S=3OAA/S=3 |
| Unconsciousness State | – | Other: OAA/S=1OAA/S=1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OAA/S=5Prior 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. | Other | Awake State |
| OAA/S=3Given 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. | Other | Sedation State |
| OAA/S=1Increasing drug concentration, EEG signatures will be recorded after reaching steady state of OAA/S=1 (does not respond to noxious stimuli) for few minutes. | Other | Unconsciousness State |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Electroencephalography
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Recruiting
Resting-State Functional Connectivity as a Predictor of tDCS Effects in Adolescents With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD), Transcranial Direct Current Stimulation (tDCS)
Recruiting
Transcranial Random Noise (tRNS) for BPSD in Alzheimer's Disease: A Double-blind Randomized Controlled Trial
Transcranial Random Noise Stimulation (tRNS), Electroencephalography
Recruiting
Integrative Medicine in Pain Management in Sickle Cell Disease, 2.0
Sickle Cell Disease, Pain
Active, not recruiting
Integrative Medicine in Pain Management in Sickle Cell Disease
Sickle Cell Disease, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electroencephalography, run by Beijing Tiantan Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.