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Remimazolam benzenesulfonate in hip replacement anesthesia--a clinical study based on EEG analysis and pharmacokinetics

Remimazolam benzenesulfonate in hip replacement anesthesia--a clinical study based on EEG analysis and pharmacokinetics

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086745
Enrollment
Unknown
Registered
2024-07-09
Start date
2024-07-15
Completion date
Unknown
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases of the elderly

Interventions

remimazolam group1:Induction with 0.2 mg/kg remimazolam
remimazolam group2:Induction with 0.3 mg/kg remimazolam

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Age 65-85 years old, gender is not limited, and unilateral elective hip replacement is to be performed. (2) ASA class I-III, 18Kg/m2=BMI=28kg/m2. (3) No serious cardiopulmonary or cerebral disease, well-controlled hypertension, diabetes mellitus and coronary heart disease. (4) Understand the experiment and participate voluntarily

Exclusion criteria

Exclusion criteria: (1) Difficult airway, lung infection and acute stage of asthma (2) Severe arrhythmia (high atrioventricular block, severe bradycardia <55 beats/min, etc.), unstable angina pectoris, poorly controlled hypertension, diabetes mellitus, coronary heart disease (3) Allergy to remazolam, propofol, long-term application of narcotic analgesics, long-term use of non-steroidal anti-inflammatory drugs and sedative drugs, long-term alcohol dependence. (4) Patients with previous mental illness or disorders of consciousness (5) The presence of metabolic, endocrine diseases, serious liver and kidney function abnormalities

Design outcomes

Primary

MeasureTime frame
The plasma concentration of remimazolam at each time point;Various pharmacokinetic parameters;Dose-response relationship of remimazolam;Time for recovery;

Secondary

MeasureTime frame
Hemodynamic effects of remimazolam;PSI at T0 (before induction of anesthesia), T1 (at the time of loss of consciousness), T2 (immediately before laryngeal mask placement), T3 (1 min after laryngeal mask placement), T4 (3 min after laryngeal mask placement), and T5 (10 min after laryngeal mask placement) were measured at each time point.;Time for Loss of consciousness;Duration when PSI<50;

Countries

Chine

Contacts

Public ContactYanLing Zhang

The Second Xiangya Hospital of Central South University

zhangyanling0618@aliyun.com+86 133 1960 6619

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026