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

NCT04601350 | Completed

• 1 other identifier: 20200922
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

remimazolam; recovery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• 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 Arms (2)

Remimazolam 1

EXPERIMENTAL

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

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 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

Remimazolam 1

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASAⅠ-Ⅱ
• Patients undergoing elective surgery under general anesthesia.
• Age, sex, and weight were not limited.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Location

MeSH Terms

Interventions

remimazolam; Anesthesia, General; Midazolam

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 23, 2020
• Study Start: November 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

CN (1)