A Randomized Controlled Trial on the Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Intraoperative Pain Control Success Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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:
研究组 & 干预措施
Anricofen 0.3 μg/kg + Ciprofol 1.0 mg/kg
干预措施: Anricofen (Drug)
Anricofen 0.5 μg/kg + Ciprofol 1.0 mg/kg
干预措施: Anricofen (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.
干预措施: Anricofen (Drug)
Anricofen 0.5 μg/kg + Ciprofol 1.0 mg/kg
干预措施: 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.
干预措施: Sufentanil (Drug)
Anricofen 0.3 μg/kg + Ciprofol 1.0 mg/kg
干预措施: Ciprofol (Drug)
结局指标
主要结局
Intraoperative Pain Control Success Rate
时间窗: During the ERCP procedure (from induction to end of procedure)
次要结局
未报告次要终点