Comparison of Remimazolam and Propofol on Emergence in Elderly Orthopedic Patients Under General Anesthesia
NCT ID: NCT06513923
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
136 participants
INTERVENTIONAL
2023-02-01
2023-10-31
Brief Summary
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Background: Previous studies have shown that flumazenil accelerates emergence time when used with remimazolam. Remimazolam and propofol have comparable emergence times, although remimazolam can be up to 5 minutes longer than propofol.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Remimazolam group
Patients will receive remimazolam for induction and maintenance of anesthesia.
Remimazolam
In Remimazolam group, the induction dose of remimazolam is 0.3 mg/kg based on previous studies, the maintenance of anesthesia is 0.3-0.7 mg/kg/hr.
Remimazolam + Flumazenil group
Patients will receive remimazolam for induction and maintenance, followed by flumazenil to reverse its effects.
Remimazolam
In Remimazolam group, the induction dose of remimazolam is 0.3 mg/kg based on previous studies, the maintenance of anesthesia is 0.3-0.7 mg/kg/hr.
Flumazenil
Immediately after the cessation of remimazolam infusion in PACU(PACU, Postanesthesia care unit), the nurses who are blind to the anesthesia management were asked to administer the flumazenil.
Propofol group
Patients will receive propofol for induction and maintenance of anesthesia.
Propofol
For propofol group, the induction of propofol is 1.5-2.0 mg/kg, followed by the maintenance of propofol infusion with 6-8 mg/kg/hr throughout the surgical procedure.
Interventions
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Remimazolam
In Remimazolam group, the induction dose of remimazolam is 0.3 mg/kg based on previous studies, the maintenance of anesthesia is 0.3-0.7 mg/kg/hr.
Flumazenil
Immediately after the cessation of remimazolam infusion in PACU(PACU, Postanesthesia care unit), the nurses who are blind to the anesthesia management were asked to administer the flumazenil.
Propofol
For propofol group, the induction of propofol is 1.5-2.0 mg/kg, followed by the maintenance of propofol infusion with 6-8 mg/kg/hr throughout the surgical procedure.
Eligibility Criteria
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Inclusion Criteria
* Scheduled for elective hip replacement surgery.
* ASA (ASA, American Society of Anesthesiologists) physical status I-III.
* Able to provide informed consent.
Exclusion Criteria
* Severe hepatic or renal impairment.
* History of benzodiazepine or alcohol abuse.
* Cognitive impairment that may interfere with the ability to provide consent.
65 Years
ALL
No
Sponsors
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Central South University
OTHER
Responsible Party
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Ru-Ping Dai
professor
Principal Investigators
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Ru-Ping MD Dai, PhD
Role: PRINCIPAL_INVESTIGATOR
Central South University
Locations
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Department of Anesthesiology, The Second Xiangya Hospital
Changsha, Hunan, China
The Second Xiangya Hospital
Changsha, Hunan, China
Countries
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Other Identifiers
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LYG2023002
Identifier Type: -
Identifier Source: org_study_id
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