Skip to content

The Clinical Study of Rimazzolam Toluene Sulfonate in ERCP Patients of Different Ages with Half Effective Dose

The Clinical Study of Rimazzolam Toluene Sulfonate in ERCP Patients of Different Ages with Half Effective Dose

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060357
Enrollment
Unknown
Registered
2022-05-29
Start date
2022-05-31
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Choledocholithiasis, suppurative cholangitis, bile duct stenosis

Interventions

50-59 years group : Remimazolam tosylate with high dose
60-69 years group : Remimazolam tosylate with mid-high dose
70-79 years group : Remimazolam tosylate with mid-low dose
80-89 years group : Remimazolam tosylate with low dose

Sponsors

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 89 Years

Inclusion criteria

Inclusion criteria: 1. 50 years old <= age <= 89 years old; 2. ASA I-III level; 3. BMI 18 kg/m2 - 30 kg/m2; 4. Endoscopic retrograde cholangiopancreatography (ERCP) under general anesthesia is needed in the elective period; 5. Be able to understand and voluntarily sign the informed consent form, and be willing to comply with the requirements of the test plan.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone and other drugs and their drug components; 2. Severe organ dysfunction in the decompensation stage: (1) Severe cardiac insufficiency (LVEF = 160 mmHg, and/or diastolic blood pressure >= 110 mmHg); 4. Uncontrolled diabetes (fasting blood sugar >= 10 mmol/L); 5. Uncontrolled coronary heart disease (history of myocardial infarction in the past 3 months, or unstable angina in the past 1 month, or untreated stable angina); 6. Patients with mental illness or those with a history of alcoholism, opioid allergy or such drug abuse; 7. Emergency surgery subjects; 8. Pregnant or lactating women; 9. Other conditions that the researchers think are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Modified observer’s assessment of alert, MOAA/S;Bispectral index (BIS) ;

Secondary

MeasureTime frame
Mean arterial pressure, MAP;Heart rate;Pulse oxygen saturation;

Countries

China

Contacts

Public ContactXu Min

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

seumexumin@163.com+86 13856904576

Outcome results

None listed

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