Remimazolam Mild SedationNCT07109362
ERP-Based Research on the Modulation of Remimazolam on Working Memory and Brain Network Mechanisms in Glioma Patients
A study testing mild sedation in people with Remimazolam Mild Sedation and Healthy Brain and Glioma Brain, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Remimazolam is a novel ultra-short-acting benzodiazepine with extensive evidence supporting its safety and efficacy in clinical anesthesia and sedation. Its perioperative use in patients with glioma is becoming increasingly common. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Remimazolam Mild Sedation, Healthy Brain and Glioma Brain
- What is being tested?
- mild sedation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2025to 15 Sep 2026
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy brain group:
- Aged 18-65 years;
- Native speakers of Chinese;
- Right-handed; ④ Normal vision or corrected vision; ⑤ Healthy brain patient population scheduled for non-neurosurgical operations and anesthesia B. Glioma brain group
- Aged 18-65 years old;
- Native speakers of Chinese;
Show all 9Show fewer
- Right-handed; ④ ASA physical status I-II;
- Normal vision or corrected vision;
- Patients with supratentorial glioma who have primary unilateral space-occupying lesions confirmed by CT/MRI and require surgery and anesthesia.
Who cannot join
- Healthy brain group:
- Allergic to remimazolam or with contraindications to remimazolam (myasthenia gravis, schizophrenia, severe depressive state);
- History of drug abuse or alcoholism;
- History of mental or neurological diseases that prevent cooperation in completing the trial; ④ Pregnant or lactating women;
- Score of mini-mental state examination (MMSE) < 27; ⑥ Past history of intracranial diseases or intracranial surgery
- Glioma brain group:
Show all 11Show fewer
- Receiving sedative treatment within 72 hours prior to the study;
- Destruction of cerebral structural integrity such as open head injury or cerebral parenchyma resection;
- Preoperative elevated intracranial pressure requiring mannitol or other intracranial pressure-lowering treatments, or preoperative radiotherapy and chemotherapy;
- History of drug abuse or alcoholism;
- Pregnant or lactating women; ⑥ Mini-Mental State Examination (MMSE) score < 27; ⑦ History of allergic reaction to remimazolam or having contraindications to remimazolam. Remimazolam is a national controlled drug with addictive properties and must be used under the guidance of a doctor; ⑧ Those with other mental or neurological diseases who are unable to cooperate in completing the trial; ⑨ Unsuitable for participating in this study due to other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Remimazolam is a novel ultra-short-acting benzodiazepine with extensive evidence supporting its safety and efficacy in clinical anesthesia and sedation. Its perioperative use in patients with glioma is becoming increasingly common. Glioma is the most common primary intracranial tumor and is often associated with neurocognitive impairment, with memory being the most frequently affected domain. Working memory, which integrates temporary storage and information processing, serves as a cognitive workspace. Currently, the impact of anesthetics on neurocognitive function during the perioperative period in glioma patients remains underexplored. This study aims to investigate the effects of remimazolam-induced mild sedation on working memory in healthy subjects and patients with supratentorial glioma by combining behavioral and electrophysiological measurements, focusing on the relationship with the P3b event-related potential amplitude. Furthermore, it explores how remimazolam sedation influences brain network functional connectivity during the encoding, maintenance, and retrieval phases of memory in healthy individuals and patients with supratentorial glioma.
- Being tested
- mild sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mild sedationDrug
In this experiment, all subjects were administered remimazolam via a TCI pump until they reached a state of mild sedation, as indicated by a MOAA/S score of 4.
| Study group | Role | What they receive |
|---|---|---|
| Healthy brain group | Other | Not described Receives: Drug: mild sedation |
| Glioma brain group | Other | Not described Receives: Drug: mild sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
behavioral results, including d', reaction time and accuracy rate
Participants completed the Sternberg working memory paradigm, with a total of 432 trials. They were required to make yes/no judgments on the memory content, and finally, the accuracy rate and average reaction time will be calculated.
Measured: All participants completed the working memory test one day before the surgery.
P3b event-related potential (ERP)
The primary electrophysiological outcome is encoding-locked P3 event-related potential amplitudes and the probe-locked P3 served as the control for the encoding-locked P3.
Measured: All participants completed the working memory test one day before the surgery, with simultaneous collection of 64-channel scalp electroencephalogram (EEG).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start8 Aug 2025
- Primary completion30 Aug 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Remimazolam Mild SedationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT07109362
- Sponsor's protocol ID
- RM20250717
- Status last verified
- Nov 2026
- First submitted
- 17 Jul 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERP-Based Research on the Modulation of Remimazolam on Working Memory and Brain Network Mechanisms in Glioma Patients
- ClinicalTrials.gov ID
- NCT07109362
- Acronym / sponsor ID
- RM20250717
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 7 Aug 2025 (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.
Remimazolam is a novel ultra-short-acting benzodiazepine with extensive evidence supporting its safety and efficacy in clinical anesthesia and sedation. Its perioperative use in patients with glioma is becoming increasingly common. Glioma is the most common primary intracranial tumor and is often associated with neurocognitive impairment, with memory being the most frequently affected domain. Working memory, which integrates temporary storage and information processing, serves as a cognitive workspace. Currently, the impact of anesthetics on neurocognitive function during the perioperative period in glioma patients remains underexplored. This study aims to investigate the effects of remimazolam-induced mild sedation on working memory in healthy subjects and patients with supratentorial glioma by combining behavioral and electrophysiological measurements, focusing on the relationship with the P3b event-related potential amplitude. Furthermore, it explores how remimazolam sedation influences brain network functional connectivity during the encoding, maintenance, and retrieval phases of memory in healthy individuals and patients with supratentorial glioma.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy brain group | Other | Drug: mild sedation |
| Glioma brain group | Other | Drug: mild sedation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy brain group:
- Aged 18-65 years;
- Aged 18-65 years old;
Key exclusion criteria (11 listed)
- Healthy brain group:
- Allergic to remimazolam or with contraindications to remimazolam (myasthenia gravis, schizophrenia, severe depressive state);
- Glioma brain group:
- Receiving sedative treatment within 72 hours prior to the study;
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 |
|---|---|---|
| mild sedationIn this experiment, all subjects were administered remimazolam via a TCI pump until they reached a state of mild sedation, as indicated by a MOAA/S score of 4. | Drug | Glioma brain group, Healthy brain group |
Primary outcome
behavioral results, including d', reaction time and accuracy rate
Time frame: All participants completed the working memory test one day before the surgery.
Participants completed the Sternberg working memory paradigm, with a total of 432 trials. They were required to make yes/no judgments on the memory content, and finally, the accuracy rate and average reaction time will be calculated.
P3b event-related potential (ERP)
Time frame: All participants completed the working memory test one day before the surgery, with simultaneous collection of 64-channel scalp electroencephalogram (EEG).
The primary electrophysiological outcome is encoding-locked P3 event-related potential amplitudes and the probe-locked P3 served as the control for the encoding-locked P3.
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 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Remimazolam Mild Sedation
RecruitingObservational study
Remimazolam-Fentanyl Mild Conscious Sedation Regimen in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
Atrial Fibrillation (AF)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mild sedation in people with Remimazolam Mild Sedation and Healthy Brain and Glioma Brain, run by Beijing Tiantan Hospital at 1 site 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 9 inclusion and 11 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
behavioral results, including d', reaction time and accuracy rate (time frame: All participants completed the working memory test one day before the surgery.). The study lists 2 primary outcomes in all. 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 4 Nov 2026.