EEG Data AnalysisNCT07468162
Characteristic Electroencephalogram of General Anesthesia
An observational study of EEG Data Analysis and Orthopedic Surgery, run by First Affiliated Hospital of Zhejiang University.
Trial summary
Patients were enrolled according to predefined inclusion and exclusion criteria. Following surgical admission, standard monitoring was initiated, including continuous assessment of heart rate, blood pressure, electrocardiogram (ECG), and peripheral capillary oxygen saturation (SpO₂). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- EEG Data Analysis, Orthopedic Surgery
- What is being tested?
- After the use of sedative drugs, the changes in the electroencephalogram (EEG) spectrum were observed with an EEG monitor
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2026to 12 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients undergoing elective orthopedic surgery under nerve block combined with intravenous anesthesia
Who may be able to join
- Age: 20 - 60 years old. BMI: 18 ≤ BMI ≤ 24 kg/m2. Right-handed. ASA classification: I - II. Patients scheduled for extremity surgery of upper and lower limbs and undergoing nerve block, those who understand and sign the informed consent form, and those receiving non-endotracheal general anesthesia with remimazolam or dexmedetomidine or midazolam, with Mallampati classification: I - II.
Who cannot join
- Skin infection at the site of nerve block puncture; history of smoking and alcohol abuse, history of brain surgery, history of cerebral infarction, mental and neurological disorders (MMSE < 18, 3D-CAM positive), history of taking any psychotropic or opioid drugs within 2 weeks, hearing impairment, cardiovascular disease, expected difficulty in airway management or sleep apnea syndrome, drug (including those with a history of allergic reaction to the test drug or contraindications for use) or food allergies, pregnant or lactating patients, patients or family members who refuse to participate, and those who refuse to undergo nerve block.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analysis of the Characteristic Electroencephalogram of Patients Undergoing Orthopedic Surgery During the Induction of General Anesthesia and the Unconscious State and Recovery Period With Electroencephalogram Monitoring Device
Patients were enrolled according to predefined inclusion and exclusion criteria. Following surgical admission, standard monitoring was initiated, including continuous assessment of heart rate, blood pressure, electrocardiogram (ECG), and peripheral capillary oxygen saturation (SpO₂). A peripheral intravenous line was established. Bispectral index (BIS) monitoring was performed continuously using a BIS monitor to assess frontal lobe electroencephalographic activity. Based on the type of surgical procedure, regional nerve block was administered. Upon confirmation of adequate block efficacy, patients were assigned to treatment groups according to sealed envelope randomization, and corresponding intravenous sedative regimens were initiated. Sedative induction agents were administered as follows: Group A received remimazolam at 0.08 mg/kg; Group B received dexmedetomidine at 1 μg/kg over 10 minutes; Group C received midazolam at 0.05 mg/kg. Maintenance infusions were as follows: Group A received remimazolam at 1 mg/kg·h; Group B received dexmedetomidine at 0.2-0.7 μg/kg·h; for Group C, if consciousness was not sufficiently suppressed with the initial dose, midazolam was supplemented in increments of 0.01 mg/kg, not exceeding a total dose of 0.1 mg/kg. Following induction, sedation depth was assessed every 2 minutes using the Observer's Assessment of Alertness/Sedation (OAA/S) scale, with auditory stimulation applied every 30 seconds until the patient no longer responded. The time to loss of response to auditory stimuli and the time to loss of consciousness were recorded. Surgical intervention was then performed. Ten minutes prior to anticipated completion of surgery, sedative infusion was discontinued. Sedation depth was reassessed every 2 minutes using the OAA/S scale, with repeated auditory stimulation every 30 seconds to determine the time to return of response and time to recovery of consciousness. If the patient had not achieved an OAA/S score of 5 within 30 minutes after discontinuation of sedation, flumazenil was administered as a reversal agent. Once the OAA/S score reached 5 or spontaneous responses to auditory stimuli were observed-indicating transition back to a responsive state-and complete electroencephalographic data had been collected, no further intervention was required.
- Conditions
- EEG Data Analysis, Orthopedic Surgery
- Being tested
- After the use of sedative drugs, the changes in the electroencephalogram (EEG) spectrum were observed with an EEG monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
After the use of sedative drugs, the changes in the electroencephalogram (EEG) spectrum were observed with an EEG monitorOther
Electroencephalogram changes under moderate deep sedation
| Study group | Role | What they receive |
|---|---|---|
| sedation of remimazolam | Electroencephalogram changes under moderate deep sedation induced by remimazolam Receives: Other: After the use of sedative drugs, the changes in the electroencephalogram (EEG) spectrum were observed with an EEG monitor | |
| sedation of dexmedetomidine | Electroencephalogram changes under moderate deep sedation induced by dexmedetomidine Receives: Other: After the use of sedative drugs, the changes in the electroencephalogram (EEG) spectrum were observed with an EEG monitor | |
| sedation of midazolam | Electroencephalogram changes under moderate deep sedation induced by midazolam Receives: Other: After the use of sedative drugs, the changes in the electroencephalogram (EEG) spectrum were observed with an EEG monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalogram changes during the perioperative period
Power changes in α and β bands of electroencephalogram during the perioperative period
Measured: From the date of random grouping until the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion12 Jan 2028 (estimated)
- Study completion12 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EEG Data AnalysisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Weiliu, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468162
- Sponsor's protocol ID
- IIT20251166B-R2
- Status last verified
- Mar 2026
- First submitted
- 8 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
Publications
Schuttler J, Eisenried A, Lerch M, Fechner J, Jeleazcov C, Ihmsen H. Pharmacokinetics and Pharmacodynamics of Remimazolam (CNS 7056) after Continuous Infusion in Healthy Male Volunteers: Part I. Pharmacokinetics and Clinical Pharmacodynamics. Anesthesiology. 2020 Apr;132(4):636-651. doi: 10.1097/ALN.0000000000003103.
PubMed 31972655Zhang H, Zhou QQ, Chen H, Hu XQ, Li WG, Bai Y, Han JX, Wang Y, Liang ZH, Chen D, Cong FY, Yan JQ, Li XL. The applied principles of EEG analysis methods in neuroscience and clinical neurology. Mil Med Res. 2023 Dec 19;10(1):67. doi: 10.1186/s40779-023-00502-7.
PubMed 38115158Schartner M, Seth A, Noirhomme Q, Boly M, Bruno MA, Laureys S, Barrett A. Complexity of Multi-Dimensional Spontaneous EEG Decreases during Propofol Induced General Anaesthesia. PLoS One. 2015 Aug 7;10(8):e0133532. doi: 10.1371/journal.pone.0133532. eCollection 2015.
PubMed 26252378Valizadeh SA, Riener R, Elmer S, Jancke L. Decrypting the electrophysiological individuality of the human brain: Identification of individuals based on resting-state EEG activity. Neuroimage. 2019 Aug 15;197:470-481. doi: 10.1016/j.neuroimage.2019.04.005. Epub 2019 Apr 9.
PubMed 30978497White-Dzuro GA, Du A, Brown EN, Akeju O, Peterfreund RA. The Effect of Midazolam Induction on Frontal Electroencephalogram Power. Anesth Analg. 2025 Nov 1;141(5):1185-1187. doi: 10.1213/ANE.0000000000007556. Epub 2025 May 23. No abstract available.
PubMed 40408296
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Characteristic Electroencephalogram of Patients Undergoing Orthopedic Surgery During the Induction of General Anesthesia and the Unconscious State and Recovery Period With Electroencephalogram Monitoring Device
- ClinicalTrials.gov ID
- NCT07468162
- Acronym / sponsor ID
- IIT20251166B-R2
- Conditions
- EEG Data Analysis, Orthopedic Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 12 Jan 2028 (estimated)
- Study completion
- 12 Jan 2028 (estimated)
- First posted
- 12 Mar 2026 (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.
Patients were enrolled according to predefined inclusion and exclusion criteria. Following surgical admission, standard monitoring was initiated, including continuous assessment of heart rate, blood pressure, electrocardiogram (ECG), and peripheral capillary oxygen saturation (SpO₂). A peripheral intravenous line was established. Bispectral index (BIS) monitoring was performed continuously using a BIS monitor to assess frontal lobe electroencephalographic activity. Based on the type of surgical procedure, regional nerve block was administered. Upon confirmation of adequate block efficacy, patients were assigned to treatment groups according to sealed envelope randomization, and corresponding intravenous sedative regimens were initiated. Sedative induction agents were administered as follows: Group A received remimazolam at 0.08 mg/kg; Group B received dexmedetomidine at 1 μg/kg over 10 minutes; Group C received midazolam at 0.05 mg/kg. Maintenance infusions were as follows: Group A received remimazolam at 1 mg/kg·h; Group B received dexmedetomidine at 0.2-0.7 μg/kg·h; for Group C, if consciousness was not sufficiently suppressed with the initial dose, midazolam was supplemented in increments of 0.01 mg/kg, not exceeding a total dose of 0.1 mg/kg. Following induction, sedation depth was assessed every 2 minutes using the Observer's Assessment of Alertness/Sedation (OAA/S) scale, with auditory stimulation applied every 30 seconds until the patient no longer responded. The time to loss of response to auditory stimuli and the time to loss of consciousness were recorded. Surgical intervention was then performed. Ten minutes prior to anticipated completion of surgery, sedative infusion was discontinued. Sedation depth was reassessed every 2 minutes using the OAA/S scale, with repeated auditory stimulation every 30 seconds to determine the time to return of response and time to recovery of consciousness. If the patient had not achieved an OAA/S score of 5 within 30 minutes after discontinuation of sedation, flumazenil was administered as a reversal agent. Once the OAA/S score reached 5 or spontaneous responses to auditory stimuli were observed-indicating transition back to a responsive state-and complete electroencephalographic data had been collected, no further intervention was required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sedation of remimazolam | – | Other: After the use of sedative drugs, the changes in the electroencephalogram (EEG) spectrum were observed with an EEG monitorElectroencephalogram changes under moderate deep sedation induced by remimazolam |
| sedation of dexmedetomidine | – | Other: After the use of sedative drugs, the changes in the electroencephalogram (EEG) spectrum were observed with an EEG monitorElectroencephalogram changes under moderate deep sedation induced by dexmedetomidine |
| sedation of midazolam | – | Other: After the use of sedative drugs, the changes in the electroencephalogram (EEG) spectrum were observed with an EEG monitorElectroencephalogram changes under moderate deep sedation induced by midazolam |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients undergoing elective orthopedic surgery under nerve block combined with intravenous anesthesia
Key inclusion criteria (1 listed)
- Age: 20 - 60 years old. BMI: 18 ≤ BMI ≤ 24 kg/m2. Right-handed. ASA classification: I - II. Patients scheduled for extremity surgery of upper and lower limbs and undergoing nerve block, those who understand and sign the informed consent form, and those receiving non-endotracheal general anesthesia with remimazolam or dexmedetomidine or midazolam, with Mallampati classification: I - II.
Key exclusion criteria (1 listed)
- Skin infection at the site of nerve block puncture; history of smoking and alcohol abuse, history of brain surgery, history of cerebral infarction, mental and neurological disorders (MMSE < 18, 3D-CAM positive), history of taking any psychotropic or opioid drugs within 2 weeks, hearing impairment, cardiovascular disease, expected difficulty in airway management or sleep apnea syndrome, drug (including those with a history of allergic reaction to the test drug or contraindications for use) or food allergies, pregnant or lactating patients, patients or family members who refuse to participate, and those who refuse to undergo nerve block.
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 |
|---|---|---|
| After the use of sedative drugs, the changes in the electroencephalogram (EEG) spectrum were observed with an EEG monitorElectroencephalogram changes under moderate deep sedation | Other | sedation of dexmedetomidine, sedation of midazolam, sedation of remimazolam |
Primary outcome
Electroencephalogram changes during the perioperative period
Time frame: From the date of random grouping until the end of the surgery
Power changes in α and β bands of electroencephalogram during the perioperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Results publication: PubMed 31972655Schuttler J, Eisenried A, Lerch M, Fechner J, Jeleazcov C, Ihmsen H. Pharmacokinetics and Pharmacodynamics of Remimazolam (CNS 7056) after Continuous Infusion in Healthy Male Volunteers: Part I. Pharmacokinetics and Clinical Pharmacodynamics. Anesthesiology. 2020 Apr;132(4):636-651. doi: 10.1097/ALN.0000000000003103.
- Results publication: PubMed 38115158Zhang H, Zhou QQ, Chen H, Hu XQ, Li WG, Bai Y, Han JX, Wang Y, Liang ZH, Chen D, Cong FY, Yan JQ, Li XL. The applied principles of EEG analysis methods in neuroscience and clinical neurology. Mil Med Res. 2023 Dec 19;10(1):67. doi: 10.1186/s40779-023-00502-7.
- Results publication: PubMed 26252378Schartner M, Seth A, Noirhomme Q, Boly M, Bruno MA, Laureys S, Barrett A. Complexity of Multi-Dimensional Spontaneous EEG Decreases during Propofol Induced General Anaesthesia. PLoS One. 2015 Aug 7;10(8):e0133532. doi: 10.1371/journal.pone.0133532. eCollection 2015.
- Results publication: PubMed 30978497Valizadeh SA, Riener R, Elmer S, Jancke L. Decrypting the electrophysiological individuality of the human brain: Identification of individuals based on resting-state EEG activity. Neuroimage. 2019 Aug 15;197:470-481. doi: 10.1016/j.neuroimage.2019.04.005. Epub 2019 Apr 9.
- Results publication: PubMed 40408296White-Dzuro GA, Du A, Brown EN, Akeju O, Peterfreund RA. The Effect of Midazolam Induction on Frontal Electroencephalogram Power. Anesth Analg. 2025 Nov 1;141(5):1185-1187. doi: 10.1213/ANE.0000000000007556. Epub 2025 May 23. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of EEG Data Analysis and Orthopedic Surgery, run by First Affiliated Hospital of Zhejiang University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact weiliu Zhu, Master (+86 15858287662, zhuweiliu1988@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalogram changes during the perioperative period (time frame: From the date of random grouping until the end of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07468162, which also lists 5 linked publications.
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 12 Mar 2026.