Effect of Remimazolam Tosilate on Postoperative Delirium in Elderly Diabetic Patients Undergoing Orthopedic Surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600116154

Enrollment

Unknown

Registered

2026-01-06

Start date

2026-01-09

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Postoperative Cognitive Dysfunction

Interventions

Propofol Group:Propofol-based total intravenous anesthesia

Remimazolam tosilate Group:Remimazolam tosilate-based total intravenous anesthesia

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Elderly diabetic patients aged >= 65 years scheduled for elective orthopedic surgery under general anesthesia; 2.American Society of Anesthesiologists (ASA) physical status I to III; 3. Body Mass Index (BMI) between 18 and 28 kg/m^2 ; 4.Normal coagulation function and independent communication skills; 5. Preoperative Mini-Mental State Examination (MMSE) score >= 26; 6.Provided written informed consent by either the patient or their legal guardian.

Exclusion criteria

Exclusion criteria: 1. Patients with a preexisting history of cognitive impairment, dementia, or delirium; 2. Patients diagnosed with major depressive disorder, schizophrenia, or other psychiatric/neurological disorders, or those with a history of using antipsychotic/antidepressant medications; 3. Presence of visual, speech, or hearing impairments; 4.Long-term use of anti-inflammatory drugs, corticosteroids, other hormonal agents, or a history of alcohol/substance dependence; 5. Known allergy to propofol or RT; 6. Severe cardiac or pulmonary insufficiency; 7. Severe hepatic or renal dysfunction.

Design outcomes

Primary

Measure	Time frame
The incidence of delirium during the first 5 postoperative days;	—

Secondary

Measure	Time frame
Hemodynamic response to intubation;Successful anesthesia induction;Hypotension following induction;Intraoperative hypotension and the types and doses of vasoactive medications used;Intraoperative hypertension and the types and doses of antihypertensive medications used;Discontinuation-to-extubation time;Post-anesthesia care unit (PACU) stay time;Postoperative nausea and vomiting (PONV); Hypoxemia in post-anesthesia care unit (PACU);Postoperative Quality of Recovery Scale (QoR score);Blood sample testing indicators on postoperative days 1–3;Unplanned ICU admission;Cognitive dysfunction at postoperative day 7 and 30;	—

Measure

Time frame

Hemodynamic response to intubation;Successful anesthesia induction;Hypotension following induction;Intraoperative hypotension and the types and doses of vasoactive medications used;Intraoperative hypertension and the types and doses of antihypertensive medications used;Discontinuation-to-extubation time;Post-anesthesia care unit (PACU) stay time;Postoperative nausea and vomiting (PONV); Hypoxemia in post-anesthesia care unit (PACU);Postoperative Quality of Recovery Scale (QoR score);Blood sample testing indicators on postoperative days 1–3;Unplanned ICU admission;Cognitive dysfunction at postoperative day 7 and 30;

—

Countries

China

Contacts

Public ContactJinli Wu

Affiliated Hospital of Guizhou Medical University

534160489@qq.com+86 189 8510 0136

Outcome results

None listed

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