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Clinical Trials/NCT04601350
NCT04601350
Completed
N/A

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

Yangzhou University1 site in 1 country80 target enrollmentNovember 1, 2020

Overview

Phase
N/A
Intervention
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
Conditions
Benzodiazepine
Sponsor
Yangzhou University
Enrollment
80
Locations
1
Primary Endpoint
The average intraoperative power spectral density in the frontal alpha band
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
June 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yangzhou University
Responsible Party
Principal Investigator
Principal Investigator

Zhuan Zhang

Director

Yangzhou University

Eligibility Criteria

Inclusion Criteria

  • 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.

Arms & Interventions

Remimazolam 1

Intervention: 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

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

Outcomes

Primary Outcomes

The average intraoperative power spectral density in the frontal alpha band

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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