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Application of remazolam in elderly patients undergoing thoracic surgery

Application of remazolam in elderly patients undergoing thoracic surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052311
Enrollment
Unknown
Registered
2021-10-24
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Clinical Anaesthesiology

Interventions

Group P:propofol
Group F:Rimazolam + flumazenil

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 60-80 years old, gender is not limited; 2. Elective surgery, general anesthesia (tracheal intubation and mechanical ventilation); 3. ASA grade II; 4.18 kg/m2<BMI<30 kg/m2; 5. Clearly understand and voluntarily participate in the research, and sign the informed consent form by himself or his legal guardian.

Exclusion criteria

Exclusion criteria: 1. Laboratory indicators do not meet all the following conditions: ANC>=1.5x10^9/L, PLT>=80x10^9/L, Hb>=90 g/L (and no blood transfusion within 14 days), AST and ALT = 180 mmHg, and/or diastolic blood pressure >= 105 mmHg); 5. Systolic blood pressure =11.1 mmol/L, and/or random blood glucose >=13.6 mmol/L); 7. Patients with craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, history of cerebrovascular accident and central nervous system diseases; mental system diseases (schizophrenia, mania, bipolar disorder, insanity, etc.) and Long-term use of psychotropic drugs and cognitive impairment; 8. History of drug and alcohol abuse within 2 years before the start of the screening period; 9. Alcoholism means drinking more than 2 units of alcohol on average per day (1 unit = 360 mL of beer or 45 mL of liquor with 40% alcohol content or 150 mL of wine); 10. Women who are pregnant or breastfeeding; 11. Those who are allergic to or have contraindications to benzodiazepines, opioids, propofol, rocuronium bromide, atropine, neostigmine mesylate and their drug components; 12. Patients who are judged to have difficulty in airway management: the modified Markov score is grade IV; 13. Participated in drug clinical trials as subjects within the past 3 months; 14. The investigators believe that patients should not participate in this trial.

Design outcomes

Primary

MeasureTime frame
Success rate of anesthesia and sedation;

Secondary

MeasureTime frame
Changes of circulatory indicators (blood pressure and heart rate) during perianaesthesia;Time and quality of recovery (MOAA/S score);length of stay in PACU;Inflammatory indexes (TNF-a, IL-6, IL-10) and oxidative stress indexes (ROS, MDA, SOD);

Countries

China

Contacts

Public ContactFang Ningning

Qilu Hospital of Shandong University

ningningfang@126.com+86 18560083771

Outcome results

None listed

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