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

RecruitingNAAges 60 Years - 90 YearsAllThe First Affiliated Hospital of Xinxiang Medical…
NCT07376577 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 regim

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📋 Eligibility rules (as published)
Inclusion Criteria: \- Inclusion Criteria: 1. Age 60-90 years. 2. American Society of Anesthesiologists (ASA) physical status II or III. 3. Scheduled for elective endoscopic retrograde cholangiopancreatography (ERCP). 4. Body mass index (BMI) between 18 and 30 kg/m². 5. Willing and able to provide written informed consent. Exclusion Criteria: 1. Severe neurological disorders (acute stroke, uncontrolled seizures, epilepsy). 2. Psychiatric disorders or cognitive impairment (Mini-Mental State Examination score \<24). 3. Uncontrolled hypertension (preoperative blood pressure ≥180/110 mmHg) or hypotension (\<90/60 mmHg). 4. Severe cardiac disease: sinus bradycardia, sick sinus syndrome, unstable angina, or myocardial infarction within the past 3 months. 5. Severe hepatic or renal dysfunction. 6. Difficult airway or severe respiratory disease. 7. Achalasia. 8. Known allergy to anricofen, sufentanil, ciprofol, or other study medications. 9. Use of opioid analgesics or sedatives within 7 days prior to surgery. 10. Preoperative pulse oxygen saturation (SpO₂) \<90% on room air. 11. Pregnancy or lactation. 12. Participation in any other drug clinical trial within the past 3 months. 13. Refusal to participate in the study. Exclusion Criteria: \-
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What it tests

  • Sufentanil
  • Anricofen
  • Ciprofol
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Where

1 site
The First Affiliated Hospital of Henan Medical University
Xinxiang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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