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Clinical trial

Effect of General Anesthesia With Remimazolam Versus Propofol on Postoperative Delirium in Elderly Patients

ID
Name
XJH-A-20220628
Description
Remimazolam is a novel benzodiazepine with ultra-short onset and offset of its effect. It can be used for general anesthesia. However, classical benzodiazepine such as midazolam was reported to increase the risk of postoperative delirium. Thus, the investigators aim to investigate the effect of remimazolam general anesthesia on postoperative delirium in elderly patients.
Trial arms
Trial start
2022-05-25
Estimated PCD
2024-01-25
Trial end
2024-01-30
Status
Recruiting
Treatment
remimazolam
continuous infusion
Arms:
remimazolam
propofol
continuous infusion
Arms:
propofol
Size
190
Primary endpoint
incidence of delirium by 3 days after surgery
from end of surgery to 3 days after surgery, in a total of 3 days
Eligibility criteria
Inclusion Criteria: * Age ≥65 years * patients scheduled for elective surgery under general anesthesia Exclusion Criteria: * American Society of Anesthesiologists status ≥Ⅳ * history of neurologic or psychiatric diseases * difficulty in communication * abuse of drug or alcohol * suspected allergy to propofol or benzodiazepines
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 190, 'type': 'ESTIMATED'}}
Updated at
2023-12-26

1 organization

2 products

1 indication

Organization
Zhihong Lu
Product
remimazolam
Indication
General Anesthetic Drug Adverse Reaction
Product
propofol