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Oliceridine-assisted propofol or ciprofol sedation for bidirectional endoscopy in elderly patients: a randomized, factorial design, multicenter clinical study

Oliceridine-assisted propofol or ciprofol sedation for bidirectional endoscopy in elderly patients: a randomized, factorial design, multicenter clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110992
Enrollment
Unknown
Registered
2025-10-23
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Bidirectional endoscopy in the elderly

Interventions

Oliceridine and propofol group:0.02mg/kg oliceridine+2mg/kg propofol ,additional intraoperative propofol 0.5mg/kg as needed.
Oliceridine and ciprofol group:0.02mg/kg oliceridine+0.4mg/kg ciprofol ,additional intraoperative ciprofol 0.1mg/kg as needed.
Saline placebo and propofol group:Saline placebo+2mg/kg propofol ,additional intraoperative propofol 0.5mg/kg as needed.
Saline placebo and ciprofol group:Saline placebo+0.4mg/kg ciprofol ,additional intraoperative ciprofol 0.1mg/kg as needed.

Sponsors

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Able to fully understand the study and voluntarily agree to participate; written informed consent obtained from the participant (or a legally authorized representative, if applicable). 2. ASA class II -III. 3. Age 65-80 years. 4. 18.5kg/m^2<=BMI<28kg/m^2. 5. Elective, same-visit bidirectional endoscopy performed consecutively under a single sedation session (same-session EGD and colonoscopy).

Exclusion criteria

Exclusion criteria: 1. Language, visual, or hearing impairment that interferes with communication. 2. Mental illness, psychological disorders, or neurological disease. 3. History of cerebrovascular accident, myocardial infarction, or unstable angina within the past 3 months; severe hepatic or renal dysfunction. 4. Known allergy or contraindication to propofol, ciprofol, opioids, or their components. 5. Recent use of analgesic, sedative, or hypnotic drugs, or a history of alcohol/substance abuse. 6. Participation in another clinical drug trial within the past 3 months. 7. Anticipated examination duration >30 minutes. 8. Determined by the investigator to be unsuitable for the trial.

Design outcomes

Primary

MeasureTime frame
Time to awakening;

Secondary

MeasureTime frame
Sedation success rate;Induction time;Procedure time;Time to discharge;Study drug utilization;Hemodynamic parameters;Use of hemodynamic support and antagonistic agents;Satisfaction;

Countries

China

Contacts

Public ContactChun Yang

Jiangsu Province People's Hospital

2037419@qq.com+86 186 2781 6797

Outcome results

None listed

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