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

Yangzhou University

Status: Completed

Conditions: Benzodiazepine

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT04601350

20200922

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Remimazolam 1

Experimental group

Treatment:

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 group

Treatment:

Drug: control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1