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Study on remimazolam for general anesthesia in geriatric orthopedic surgery

Study on remimazolam for general anesthesia in geriatric orthopedic surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072351
Enrollment
Unknown
Registered
2023-06-12
Start date
2023-06-12
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Postoperative delirium

Interventions

Remimazolam group:Remimazolam
Propofol group:Propofol

Sponsors

Xi'an International Medical Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: Geriatrc patients undergoing orthopedic surgery under general anesthesia, 90>age>65, 30>BMI>18, no gender limitation, ASA I-III, surgery duration time>1 hour.

Exclusion criteria

Exclusion criteria: 1) Patients with endocrine diseases such as Cushing syndrome, pituitary adenomas and adrenal tumors; 2) Patients who use hormone drugs within three months before operation; 3) Patients with asthma; 4) Patients with severe respiratory diseases (obstructive sleep apnea syndrome, acute respiratory infection, acute attack of chronic obstructive pulmonary disease, uncontrolled asthma, active massive hemoptysis, severe pulmonary hypertension, etc.). 5) Acute heart failure; unstable angina pectoris; myocardial infarction within 6 months before screening; resting ECG heart rate ULN+3s and / or APTT > ULN+10s); 10) Abnormal liver function: AST and / or ALT = 2.5 × ULN,TBIL = 1.5 × ULN. 11) Abnormal renal function: urea or urea nitrogen = 1.5 × ULN, serum creatinine was higher than the normal limit; 12) History of drug abuse, drug use and alcohol abuse in the 2 years before the beginning of the screening period. Alcoholism means drinking an average of more than 2 units of alcohol per day (1 unit = 360mL beer or 45mL liquor or 150mL wine with 40% alcohol content). 13) Patients who did not receive regular antihypertensive therapy or poorly controlled blood pressure (sitting systolic blood pressure = 160mmHg or = 90mmHg during screening, and / or diastolic blood pressure = 100 mmHg during screening); 14) Patients whose blood sugar was not satisfactorily controlled (random blood glucose = 11.1mmol/L during screening); 15) Patients who are allergic or contraindicated to benzodiazepines, opioids, sevoflurane and their drug components; 16) Patients who are determined to have difficulties in respiratory tract management (modified M score IV); 17) Patients have participated in any clinical drug trials as subjects in the past 3 months and have used the trial drugs; 18) The expected operation time is less than 1 hour; 19) other factors that may interfere with the results of the experiment.

Design outcomes

Primary

MeasureTime frame
Postoperative delirium ;

Secondary

MeasureTime frame
Postoperative cognitive dysfunction ;Awakening time;PACU residence time;Ramsay Sedation Score when leaving PACU;NRS score when leaving PACU;Length of stay in hospital;Mortality rate;Adverse reactions during anesthesia and recovery period;

Countries

China

Contacts

Public ContactJiaxuan He

Xi'an International Medical Center Hospital

hjx1001004@163.com+86 139 9196 1432

Outcome results

None listed

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