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Completed

NCT Number: NCT04601350

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

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.

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Key information

Conditions

Benzodiazepine

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. 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.

  2. 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

  1. Changes in IL-6, IL-10, and S100-β levels

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 23, 2020
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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