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Remimazolam versus propofol total intravenous anesthesia on postoperative delirium in elderly patients undergoing cardiac valve surgery: A randomised controlled clinical trial

Remimazolam versus propofol total intravenous anesthesia on postoperative delirium in elderly patients undergoing cardiac valve surgery: A randomised controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128326
Enrollment
Unknown
Registered
2026-07-17
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

Postoperative delirium

Interventions

The propofol group (Group P):1. Anesthesia induction: Propofol at 1.0-1.5mg/kg, sufentanil at 0.5-1µg/kg, and rocuronium at 0.6mg/kg are used. 2. Anesthesia maintenance: Propofol 3-10mg/kg/h, cisatrac
The remimazolam group (Group R):1.Anesthesia induction: Remimazolam 0.2-0.3mg/kg (injection time >=30 seconds), sufentanil 0.5-1µg/kg, rocuronium 0.6mg/kg were used
2.Anesthesia maintenance: Remimazolam 0.5-2.0mg/kg/h, cisatracurium 0.1-0.2mg/kg/h 3.During ICU stay: Continuous intravenous infusion of remimazolam (0.1-0.3mg/kg/h)

Sponsors

Zhongda Hospital Affiliated to Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for their first cardiac valve surgery under CPB; 2. Age >= 65 years old, gender not limited; 3. Classified as grade II-IV by the American Society of Anesthesiologists (ASA); 4. It has been reviewed and approved by the ethics committee of this hospital, and an informed consent form has been signed with the patient or their family.

Exclusion criteria

Exclusion criteria: 1. Preoperative cognitive impairment: The Mini-Mental State Examination (MMSE) score was used: illiterate <=17 points, primary school <=20 points, junior high school and above <=24 points; 2. Patients with a history of severe mental disorders (such as depression, bipolar disorder, schizophrenia, etc.) 3. Previous history of neurosurgery, obvious neurological diseases such as epilepsy, Parkinson's disease or dementia; 4. There was severe liver and kidney failure before the operation (Child-Pugh grade C, or serum creatinine clearance rate <30ml/min, or renal replacement therapy was required); 5. Preoperative respiratory failure dependent on mechanical ventilation; 6. Allergic to remimazolam or propofol; 7. Unable to communicate due to severe visual, auditory or language impairments; 8. Patients with myasthenia gravis; 9. Patients undergoing major vascular surgery who require deep hypothermic circulatory arrest.

Design outcomes

Primary

MeasureTime frame
the incidence of delirium within the first 7 postoperative days;

Secondary

MeasureTime frame
Incidence of hypotension after induction;Postoperative recovery parameters: duration of mechanical ventilation (h), length of stay in the ICU (h), total length of stay (days), postoperative nausea and vomiting;Delirium duration;Adverse events related to sedative drugs;30 day all-cause mortality;Other complications;NRS scores at 24 and 48 hours after operation;Subtype of delirium;The changes of inflammatory factors such as IL-6 and IL-1ß and the biomarker S100ß in serology before and 24 hours after the operation;Cumulative EEG burst suppression time;The patient recovered quality 7 days after the operation;

Countries

China

Contacts

Public ContactYao Juan

Zhongda Hospital Affiliated to Southeast University

yaojuanmazui@163.com+86 25 83262529

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026