Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Und… (NCT07376577) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing ERCP
141 participantsStarted 2026-01-01
Plain-language summary
Background: Endoscopic retrograde cholangiopancreatography (ERCP) is a key technique for treating pancreatobiliary diseases in the elderly. However, traditional sedative and analgesic regimens (e.g., sufentanil combined with propofol) are associated with a high incidence of respiratory depression, postoperative nausea and vomiting (PONV), and delayed recovery in elderly patients. Anricofen is a novel peripherally selective κ-opioid receptor agonist that provides analgesia with minimal central respiratory depression. Ciprofol is a new sedative agent characterized by rapid onset and quick recovery. The combination of these two drugs may offer a safer sedation and analgesia regimen for elderly patients undergoing ERCP.
Objective: To evaluate the efficacy and safety of anricofen combined with ciprofol for deep sedation in elderly patients undergoing ERCP, compared with the traditional regimen (sufentanil combined with ciprofol).
Methods: This is a single-center, randomized, double-blind, controlled trial. A total of 141 elderly patients aged 60-90 years with ASA physical status II-III scheduled for elective ERCP will be enrolled and randomly assigned in a 1:1:1 ratio to three groups: Anricofen 0.3 μg/kg + Ciprofol 1.0 mg/kg, Anricofen 0.5 μg/kg + Ciprofol 1.0 mg/kg, or Sufentanil 0.1 μg/kg + Ciprofol 1.0 mg/kg. The primary efficacy endpoint is the intraoperative pain control success rate (proportion of time with Behavioral Pain Scale \[BPS\] score ≤3 ≥90%). The primary safety endpoint is the incidence of respiratory depression (respiratory rate \<10 breaths/min or SpO₂ \<90% requiring intervention). Secondary outcomes include sedation depth, body movement episodes, recovery time, PONV incidence, and others.
Significance: This study aims to provide a sedation and analgesia regimen with lower risk of respiratory depression and faster recovery for elderly patients undergoing ERCP.
Who can participate
Age range
60 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 60-90 years.
. American Society of Anesthesiologists (ASA) physical status II or III.
. Scheduled for elective endoscopic retrograde cholangiopancreatography (ERCP).
. Body mass index (BMI) between 18 and 30 kg/m².
. Willing and able to provide written informed consent.
Exclusion criteria
. Severe neurological disorders (acute stroke, uncontrolled seizures, epilepsy).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intraoperative Pain Control Success Rate
Timeframe: During the ERCP procedure (from induction to end of procedure)
Trial details
NCT IDNCT07376577
SponsorThe First Affiliated Hospital of Xinxiang Medical College