Benzodiazepine Clinical Trial
Official title:
Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function
NCT number | NCT04601350 |
Other study ID # | 20200922 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2020 |
Est. completion date | June 1, 2022 |
Verified date | January 2024 |
Source | Yangzhou University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | June 1, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - ASA?-? - Patients undergoing elective surgery under general anesthesia. - Age, sex, and weight were not limited. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | the Affiliated Hospital of Yangzhou University, Yangzhou University | Yangzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Yangzhou University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Preoperatively, During operation,End of operation | |
Primary | 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 | The outcome above should be measured the day before surgery and 1,2,3,5,7 days after surgery | |
Secondary | Changes in IL-6, IL-10, and S100-ß levels | The outcome above should be measured the day before surgery and 1,3 days after surgery | The outcome above should be measured the day before surgery and 1,3 days after surgery |
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