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Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing ERCP
Sponsor: The First Affiliated Hospital of Xinxiang Medical College
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.
Official title: A Randomized Controlled Trial on the Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography
Key Details
Gender
All
Age Range
60 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
141
Start Date
2026-01-01
Completion Date
2028-05-01
Last Updated
2026-01-29
Healthy Volunteers
No
Conditions
Interventions
Sufentanil
Sufentanil is a potent synthetic opioid analgesic acting primarily on μ-opioid receptors. It is commonly used for analgesia during surgical and endoscopic procedures. In this study, it serves as the active comparator in combination with ciprofol. It is administered intravenously.
Anricofen
Anricofen is a novel peripherally selective κ-opioid receptor agonist. It provides analgesia primarily through peripheral mechanisms with minimal central nervous system penetration, thereby reducing the risk of respiratory depression and addiction compared to traditional μ-opioid agonists. It is administered intravenously.
Ciprofol
Ciprofol is a novel intravenous sedative agent with higher lipophilicity than propofol, leading to faster onset and recovery. It exhibits less cardiovascular depression compared to propofol and is suitable for procedural sedation, particularly in elderly patients. It is administered intravenously.