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Efficacy and Safety of Remimazolam Combined with Hydrocodone for Elderly Patients Undergoing ERCP: A Multicenter Randomized Controlled Trial

Efficacy and Safety of Remimazolam Combined with Hydrocodone for Elderly Patients Undergoing ERCP: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123715
Enrollment
Unknown
Registered
2026-04-29
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

choledocholithiasis , Bile duct stenosis

Interventions

Rimazolen combined with hydrocodone (R) group:Intravenous injection of 0.1 mg/kg hydrocodone (injection time 30 seconds), followed by intravenous injection of 0.15-0.3 mg/kg remifentanil 3 minutes lat
Propofol combined with sufentanil (P) group:Intravenous injection of sufentanil at a dose of 0.1 µg/kg (pushed over 30 seconds), followed by intravenous injection of propofol at a dose of 1-2 mg/kg 3

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for ERCP (common bile duct stones, biliary stricture, cholangiocarcinoma, etc.); 2. Age: 65–85 years; 3. American Society of Anesthesiologists (ASA) classification: I–III; 4. Agree to and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Body weight 40 kg/m^2; 2. History of anticipated difficult airway or severe respiratory system disease: acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, sleep apnea syndrome (STOP-Bang score >=5), etc.; 3. History of uncontrolled hypertension (or admission systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg); 4. Obvious clinical symptoms of liver, kidney, hematologic, nervous system, or endocrine system diseases; 5. Chronic pain with long-term use of analgesics or psychotropic drugs; 6. Mental illness with a history of taking monoamine oxidase inhibitors or antidepressants within 15 days; 7. Allergy to any drugs involved in the study; 8. Participation in other drug clinical trials within the past three months; 9. Hearing, vision, or speech impairment that hinders communication; 10. Expected ERCP procedure duration >2 hours.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;Postoperative recovery time;Postoperative nausea and vomiting score;

Secondary

MeasureTime frame
Incidence of hypoxemia;Cardiovascular adverse events;

Countries

China

Contacts

Public ContactLining Huang

The Second Hospital of Hebei Medical University

hlncctv@163.com+86 158 0321 3730

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026