Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function
- Conditions
- Benzodiazepine
- Interventions
- Drug: control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1
- Registration Number
- NCT04601350
- Lead Sponsor
- Yangzhou University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- ASAⅠ-Ⅱ
- Patients undergoing elective surgery under general anesthesia.
- Age, sex, and weight were not limited.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remimazolam 1 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 control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
the Affiliated Hospital of Yangzhou University, Yangzhou University
🇨🇳Yangzhou, Jiangsu, China
the Affiliated Hospital of Yangzhou University, Yangzhou University🇨🇳Yangzhou, Jiangsu, China