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

NCT ID: NCT04601350

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-06-01

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.

Conditions

Benzodiazepine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Remimazolam 1

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

remimazolam group was remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia

Control

Group Type: OTHER

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

Intervention Type: DRUG

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

Interventions

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

remimazolam group was remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia

Intervention Type: DRUG

control 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Zhang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

20200922

Identifier Type: -

Identifier Source: org_study_id