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The impact of remimazolam tosylate for injection on intraoperative stress response and postoperative cognitive function in elderly patients undergoing ERCP

The impact of remimazolam tosylate for injection on intraoperative stress response and postoperative cognitive function in elderly patients undergoing ERCP

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111750
Enrollment
Unknown
Registered
2025-11-05
Start date
2022-09-01
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Cholecystectasis

Interventions

Remimazolam group:The sedative drugs used for anesthesia induction and maintenance are remimazolam.
Propofol group:The sedative drugs used for anesthesia induction and maintenance are propofol.

Sponsors

Shandong Provincial Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years old, gender unrestricted; 2. Patients undergoing routine ERCP diagnosis and treatment; 3. ASA score of I or II; 18 kg/m² < BMI < 30 kg/m²; 4.Clearly understand and voluntarily participate in this study, and sign the informed consent form by themselves.

Exclusion criteria

Exclusion criteria: 1. Patients with mental disorders, significant memory impairment, and neurological dysfunction; 2. Patients suspected of having gastric and duodenal outlet obstruction with retained contents; 3. Acute heart failure; unstable angina pectoris; myocardial infarction within 6 months before screening; 4. Patients with severe respiratory diseases; 5. Anemia or thrombocytopenia, PLT = 1.5×ULN; 7. Hypertensive patients whose blood pressure is not well controlled despite antihypertensive drug treatment; 8. Individuals who are allergic or have contraindications to benzodiazepines.

Design outcomes

Primary

MeasureTime frame
mini mental state examinsation;

Secondary

MeasureTime frame
systolic blood pressure;diastolic blood pressure;heart rate;modified observer’s assessment of alert/sedation;time of operation;anesthesia duration;Intraoperative blood loss;Total remimazolam dosage;Total amount of propofol;Total amount of remifentanil;blood glucose;NE;S100ß;

Countries

China

Contacts

Public ContactHu Jing

Shandong Provincial Third Hospital

hujing2180@126.com+86 151 6888 2671

Outcome results

None listed

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