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CompletedNCT04601350Updated Jan 16, 2024

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

An interventional study of 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 and control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1 in Benzodiazepine, sponsored by Yangzhou University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2024-01-16.

Sponsored by Yangzhou University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Benzodiazepine

Keywords

  • remimazolam
  • recovery
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In context

Lead sponsor

Yangzhou University is the lead sponsor of 40 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Remimazolam 1

    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

  • Other
    Control

    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

  • Drugremimazolam 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

  • Drugcontrol 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Preoperatively, During operation,End of operation

  2. 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

    Time frame: 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

    Time frame: The outcome above should be measured the day before surgery and 1,3 days after surgery

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Study locations

1 site
  • the Affiliated Hospital of Yangzhou University, Yangzhou University
    Yangzhou, Jiangsu, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04601350
Lead sponsor
Yangzhou University
Responsible party
Zhuan Zhang (Director, Yangzhou University) — Principal investigator
First posted
Oct 23, 2020
Start date
Nov 1, 2020
Primary completion
May 1, 2022
Completion
Jun 1, 2022
Last update
Jan 16, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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