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

Benzodiazepine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04601350
• Other study ID #: 20200922
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: January 2024
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ASA?-?

• 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.

Related Conditions & MeSH terms

• Benzodiazepine

Intervention

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
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 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

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average intraoperative power spectral density in the frontal alpha band	EEG data were collected at the beginning of the room admission, and the collection was ended at the end of the operation.	Preoperatively, During operation,End of operation
Primary	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	Changes in IL-6, IL-10, and S100-ß 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