A Randomized Controlled Trial on the Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 141
- Primary Endpoint
- Intraoperative Pain Control Success Rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
- •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.
- •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:
Arms & Interventions
Anricofen 0.3 μg/kg + Ciprofol 1.0 mg/kg
Intervention: Anricofen (Drug)
Anricofen 0.3 μg/kg + Ciprofol 1.0 mg/kg
Intervention: Ciprofol (Drug)
Anricofen 0.5 μg/kg + Ciprofol 1.0 mg/kg
Intervention: Anricofen (Drug)
Anricofen 0.5 μg/kg + Ciprofol 1.0 mg/kg
Intervention: Ciprofol (Drug)
Sufentanil 0.1 μg/kg + Ciprofol 1.0 mg/kg
Participants receive intravenous sufentanil at a dose of 0.1 μg/kg (standard clinical dose) combined with ciprofol at 1.0 mg/kg for induction of deep sedation prior to ERCP. This regimen serves as the active control. Supplemental doses (one-third of the initial sufentanil dose and one-fourth of the initial ciprofol dose) may be administered during the procedure if needed based on behavioral pain score (BPS >3) or body movements.
Intervention: Sufentanil (Drug)
Sufentanil 0.1 μg/kg + Ciprofol 1.0 mg/kg
Participants receive intravenous sufentanil at a dose of 0.1 μg/kg (standard clinical dose) combined with ciprofol at 1.0 mg/kg for induction of deep sedation prior to ERCP. This regimen serves as the active control. Supplemental doses (one-third of the initial sufentanil dose and one-fourth of the initial ciprofol dose) may be administered during the procedure if needed based on behavioral pain score (BPS >3) or body movements.
Intervention: Anricofen (Drug)
Outcomes
Primary Outcomes
Intraoperative Pain Control Success Rate
Time Frame: During the ERCP procedure (from induction to end of procedure)
Secondary Outcomes
No secondary outcomes reported