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Effect of different doses of remazolam versus propofol on the incidence of delirium in elderly patients after noncardiac surgery: a single-center, prospective, randomized controlled trial

Effect of different doses of remazolam versus propofol on the incidence of delirium in elderly patients after noncardiac surgery: a single-center, prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082176
Enrollment
Unknown
Registered
2024-03-22
Start date
2024-03-22
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

Postoperative delirium

Interventions

The remazolam group(R1 group):Remazolam was given 0.15mg/kg for general anesthesia induction
The remazolam group(R2 group):Remazolam was given 0.3mg/kg for general anesthesia induction
Propofol group (P group):General anesthesia was induced with propofol 1.5mg/kg

Sponsors

The General Hospital of the PLA Northern Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 60-80 years old, gender unlimited; 2. Patients with tracheal intubation and general anesthesia under non-cardiac surgery; The operation site should be abdominal operation. Duration of operation 4h; 3. ASA scores ? ~ ?; 4. BMI 18-30kg/m2; 5. Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Unable to communicate verbally due to deafness; 2. Patients with difficult airway were improved Mallampati grade ?; 3. Preoperative delirium or dementia; 4. History of severe cardiovascular disease and uncontrollable diabetes before surgery; Serious injury or disease of vital organs such as the lungs, brain, liver or kidney; 5. Patients with severe consciousness disorder or mental system disease (schizophrenia, mania, insanity, etc.) and cognitive dysfunction; 6. Intolerance or allergy to benzodiazepines; 7. History of alcoholism; And a history of drug addiction or other substance abuse.

Design outcomes

Primary

MeasureTime frame
Postoperative delirium;

Secondary

MeasureTime frame
Onset and duration of delirium;Quality of awakening;The time of onset of sedation until loss of consciousness;Induction success rate of general anesthesia;Cumulative doses of vasoactive drugs;Total amount of remazolam, remifentanil and propofol used during operation;Blood pressure, heart rate, BIS ;Correlation between Remazolam and BIS;Pain measurement;Incidence of postoperative nausea and vomiting;Incidence of adverse reactions (hypotension, bradycardia, injection pain);Postoperative recovery quality;

Countries

China

Contacts

Public ContactDiao Yugang

The General Hospital of the PLA Northern Theater Command

diao72@163.com+86 153 0988 1160

Outcome results

None listed

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