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Remimazolam on hemodynamics in older patients under lower extremity orthopedic surgery with spinal anesthesia

Remimazolam on hemodynamics in older patients under lower extremity orthopedic surgery with spinal anesthesia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083380
Enrollment
Unknown
Registered
2024-04-23
Start date
2024-04-23
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

intraoperative hemodynamic

Interventions

Rimazolam sedation group (Group R):In group R, rimazolam 0.1 mg/kg was given after plane fixation, followed by 5 µg/kg/min continuous pumping until the BIS dropped to 75, then the infusion rate was gr

Sponsors

Central Hospital Of Dalian University of Technology(Dalian Municipal Central Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. All sexes, aged > 60 years, ASA Class I-III; 2. Patients undergoing elective lower limb orthopaedic surgery; 3. Patients who have signed the informed consent and subject declaration.

Exclusion criteria

Exclusion criteria: Patients or family members who refuse to participate in the experiment; contraindications for combined spinal-epidural anesthesia (i.e., coagulopathy, infection at the puncture site, and refusal of combined spinal-epidural anesthesia); history of brain trauma or brain surgery; concurrent severe anemia, history of psychotropic drug or alcohol abuse; concurrent severe cardiac insufficiency (left ventricular ejection fraction EF < 30%) or bradycardia (heart rate < 60 beats per minute); significant impairment of hearing or vision, inability to communicate and cooperate (coma, dementia, language dysfunction); patients with malignant tumors; allergies to anesthetic drugs; patients or family members with poor compliance; those who change the original treatment plan.

Design outcomes

Primary

MeasureTime frame
Changes of mean arterial pressure (MAP);Changes of heart rate (HR);Incidence of cardiovascular adverse events;

Secondary

MeasureTime frame
Changes of Bispectral index value(BIS);Consumption of atropine;Postoperative delirium;Visual Analogue Scale (VAS) score;Consumption of norepinephrine;

Countries

China

Contacts

Public ContactCongjie Bi

Central Hospital Of Dalian University of Technology(Dalian Municipal Central Hospital)

bcj0411@126.com+86 135 0425 1513

Outcome results

None listed

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