Benzodiazepine
Conditions
Keywords
remimazolam, recovery
Brief 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 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.
Interventions
DRUGremimazolam 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
remimazolam group was remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia
DRUGcontrol group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1
control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1
Sponsors
Yangzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* ASAⅠ-Ⅱ * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The average intraoperative power spectral density in the frontal alpha band | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | The outcome above should be measured the day before surgery and 1，3 days after surgery |
Countries
China
Outcome results
None listed