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Effect of different depths of anaesthesia by Remimazolam Besylate infusion on postoperative neurocognitive function in elderly hip fracture surgery

Effect of different depths of anaesthesia by Remimazolam Besylate infusion on postoperative neurocognitive function in elderly hip fracture surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076745
Enrollment
Unknown
Registered
2023-10-17
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Postoperative cognitive dysfunction

Interventions

deep anaesthesia group:Maintaining deep anaesthesia intraoperatively
Light anaesthesia group:Maintenance of intraoperative light anaesthesia

Sponsors

Lishui People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 65 years<Age = 90 years (male and female are not limited); 2. ASA grade ? ~ ?; 3.18 kg/m2 = BMI = 30 kg/m2; 4.Respiratory rate should be = 10 and = 24 times/minute in the screening and baseline periods; SpO2 should be = 95% when aspirating air; SBP = 90 mmHg; DBP = 60 mmHg; heart rate = 60 and = 100 beats/minute; 5. Understand the procedures and methods of this study, participate voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Contraindications to general anesthesia; 2, have a history of benzodiazepine allergy, or long-term use of benzodiazepines; 3, accompanied by infectious heart diseases such as myocarditis or endocarditis, sepsis; 4, craniocerebral injury, possible intracranial hypertension, brain aneurysm, cerebrovascular accident history of disease; 5. Acute heart failure, unstable angina pectoris, myocardial infarction within 6 months before screening, resting ECG heart rate =50 beats/min, third degree atrioventricular block and other serious arrhythmias, and serious heart valve disease; 6, abnormal liver and kidney function (ALT or AST=2.5 times the upper limit of normal value, TBIL=1.5 times the upper limit of normal value), abnormal kidney function (BUN or Urea=1.5 times the upper limit of normal value, Cr> Upper limit of normal, or dialysis treatment within 28 days prior to surgery), or significantly abnormal coagulation function (PT/APTT/TT higher than the upper limit of normal), anemia or thrombocytopenia (Hb=90g/L, PLT=80×109/L); 7. Patients with unsatisfactory blood pressure control (SBP=160mmHg, and/or DBP= 100mmHg during the screening period); 8. Seated systolic blood pressure SBP=90mmHg during the screening period; 9. Diabetic subjects whose blood glucose was not satisfactorily controlled (fasting blood glucose =11.1mmol/L during screening, and/or random blood glucose = 13.6mmol /L); 10, a history of drug use and alcohol abuse within 2 years prior to the start of the screening period, alcohol abuse was defined as regular drinking of more than 14 times/week (1 time =150 ml wine or 360 ml beer or 45 ml spirits); 11. Subjects who are judged to have difficulty managing their respiratory tract have a modified Markov score of level IV; 12. Participants who have participated in any clinical trial as a subject within 3 months before enrollment; 13. Other conditions deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative delirium (POD) at 7 days;

Secondary

MeasureTime frame
Incidence of delayed neurocognitive recovery (DNR) after surgery;Postoperative neurocognitive disorders;Incidence of postoperative nausea and vomiting;Incidence of intraoperative knowledge;Incidence of intraoperative amnesia;

Countries

China

Contacts

Public ContactWujimin

Lishui People's Hospital

wujimin2022@163.com+86 189 5709 1906

Outcome results

None listed

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