BenzodiazepineNCT04601350
Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function
A study testing remimazolam group was induced with remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia in people with Benzodiazepine, run by Yangzhou University at 1 site in China.
Trial summary
Benzodiazepine sedative hypnotics are commonly used intravenous anesthetics in clinical practice. Remimazolam is a new benzodiazepine with the characteristics of rapid onset, short maintenance and recovery time, no accumulation, metabolism independent of liver and kidney function, and no serious side effects, which… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Benzodiazepine
- What is being tested?
- remimazolam group was induced with remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 1 Jun 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASAⅠ-Ⅱ
- Patients undergoing elective surgery under general anesthesia.
- Age, sex, and weight were not limited.
Who cannot join
- Allergic or contraindication to remimazolam/midazolam/remifentanil;
- Abnormal liver and kidney function; Alcohol abuse;
- Long-term use of sedative, analgesic or anxiolytic drugs;
- Hearing and language communication disorders;
- Complicated with severe cardiovascular lesions or neurological diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu
About this study
Benzodiazepine sedative hypnotics are commonly used intravenous anesthetics in clinical practice. Remimazolam is a new benzodiazepine with the characteristics of rapid onset, short maintenance and recovery time, no accumulation, metabolism independent of liver and kidney function, and no serious side effects, which has a good prospect for clinical application. Now we will study the effects of remimazolam on EEG and postoperative cognitive function ，in order to further understand the clinical application of remimazolam.
- Conditions
- Benzodiazepine
- Being tested
- remimazolam group was induced with remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia, control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1
- Keywords
- remimazolam, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolam group was induced with remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesiaDrug
remimazolam group was remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia
control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1Drug
control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam 1 | Experimental | Not described Receives: Drug: remimazolam group was induced with remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia |
| Control | Other | Not described Receives: Drug: control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average intraoperative power spectral density in the frontal alpha band
EEG data were collected at the beginning of the room admission, and the collection was ended at the end of the operation.
Measured: Preoperatively, During operation，End of operation
Changes in the score of MMSE
The outcome above should be measured the day before surgery and 1,2,3,5,7 days after surgery
Measured: The outcome above should be measured the day before surgery and 1,2,3,5,7 days after surgery
Secondary outcomes (1)
Changes in IL-6, IL-10, and S100-β levels
The outcome above should be measured the day before surgery and 1，3 days after surgery
Measured: The outcome above should be measured the day before surgery and 1，3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Nov 2020
- Primary completion1 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BenzodiazepineStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601350
- Sponsor's protocol ID
- 20200922
- Status last verified
- Jan 2024
- First submitted
- 5 Oct 2020
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function
- ClinicalTrials.gov ID
- NCT04601350
- Acronym / sponsor ID
- 20200922
- Conditions
- Benzodiazepine
- Keywords
- remimazolam, recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 23 Oct 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.
Benzodiazepine sedative hypnotics are commonly used intravenous anesthetics in clinical practice. Remimazolam is a new benzodiazepine with the characteristics of rapid onset, short maintenance and recovery time, no accumulation, metabolism independent of liver and kidney function, and no serious side effects, which has a good prospect for clinical application. Now we will study the effects of remimazolam on EEG and postoperative cognitive function ，in order to further understand the clinical application of remimazolam.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam 1 | Experimental | Drug: remimazolam group was induced with remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia |
| Control | Other | Drug: control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ASAⅠ-Ⅱ
- Patients undergoing elective surgery under general anesthesia.
- Age, sex, and weight were not limited.
Key exclusion criteria (5 listed)
- Allergic or contraindication to remimazolam/midazolam/remifentanil;
- Abnormal liver and kidney function; Alcohol abuse;
- Long-term use of sedative, analgesic or anxiolytic drugs;
- Hearing and language communication disorders;
- Complicated with severe cardiovascular lesions or neurological diseases.
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 |
|---|---|---|
| remimazolam group was induced with remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesiaremimazolam group was remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia | Drug | Remimazolam 1 |
| control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1 | Drug | Control |
Primary outcome
The average intraoperative power spectral density in the frontal alpha band
Time frame: Preoperatively, During operation，End of operation
EEG data were collected at the beginning of the room admission, and the collection was ended at the end of the operation.
Changes in the score of MMSE
Time frame: The outcome above should be measured the day before surgery and 1,2,3,5,7 days after surgery
The outcome above should be measured the day before surgery and 1,2,3,5,7 days after surgery
1 secondary outcome
Changes in IL-6, IL-10, and S100-β levels
Time frame: The outcome above should be measured the day before surgery and 1，3 days after surgery
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 16 Jan 2024.
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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. 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 remimazolam group was induced with remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia in people with Benzodiazepine, run by Yangzhou University 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 3 inclusion and 5 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 16 Jan 2024. 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?
The average intraoperative power spectral density in the frontal alpha band (time frame: Preoperatively, During operation，End of operation). 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 16 Jan 2024; AzTrials last refreshed its copy on 26 Oct 2026.