Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing ERCP

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Conditions studied: Anesthesia, Sedation, ERCP, Ciprofol

In brief

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.

Key facts

Study ID: NCT07376577
Run by: The First Affiliated Hospital of Xinxiang Medical College
People needed: 141
Starts: 2026-01-01
Expected to finish: 2028-05-01
Last updated by the study team: 2026-01-29

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Severe neurological disorders (acute stroke, uncontrolled seizures, epilepsy).
Psychiatric disorders or cognitive impairment (Mini-Mental State Examination score <24).
Uncontrolled hypertension (preoperative blood pressure ≥180/110 mmHg) or hypotension (<90/60 mmHg).
Severe cardiac disease: sinus bradycardia, sick sinus syndrome, unstable angina, or myocardial infarction within the past 3 months.
Severe hepatic or renal dysfunction.
Difficult airway or severe respiratory disease.
Achalasia.
Known allergy to anricofen, sufentanil, ciprofol, or other study medications.
Use of opioid analgesics or sedatives within 7 days prior to surgery.
Preoperative pulse oxygen saturation (SpO₂) <90% on room air.
Pregnancy or lactation.
Participation in any other drug clinical trial within the past 3 months.
Refusal to participate in the study.
Exclusion Criteria:

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