Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function

Not Applicable

Completed

• Conditions: Benzodiazepine
• Interventions: 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; 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

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-23
• Study Start: 2020-11-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-06-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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