Effects of Esketamine-Propofol Versus Sufentanil-Propofol Sedation on Hypoxemia and Hypotension During Endoscopic Retrograde Cholangiopancreatography (ERCP)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 530
- 主要终点
- Incidence of intraoperative hypoxemia
研究概览
简要总结
This study compares two anesthesia medications, esketamine and sufentanil, used together with propofol during ERCP procedures. The goal is to find out which combination provides better safety and comfort for people undergoing ERCP.
Participants will be randomly assigned to receive either esketamine or sufentanil during sedation. Researchers will monitor blood oxygen levels, blood pressure, and recovery time during and after the procedure to evaluate safety and effectiveness.
详细描述
This randomized controlled trial compares the effects of intravenous esketamine and intravenous sufentanil as adjuncts to propofol sedation in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).
The study aims to evaluate differences in intraoperative hemodynamic stability, oxygenation, sedation quality, and recovery profiles between the two sedation strategies.
Participants will be randomly assigned to receive either esketamine or sufentanil in combination with propofol during the ERCP procedure. Sedation will be titrated to achieve an adequate level of sedation based on clinical assessment.
Standard monitoring will be applied throughout the procedure, including continuous pulse oximetry and non-invasive blood pressure measurement at predefined time points. Hemodynamic instability, including hypotension and oxygen desaturation, will be managed according to predefined clinical protocols.
Adverse events will be recorded throughout the perioperative period and assessed for severity and relatedness to the study interventions.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Due to pharmacodynamic differences between study drugs, the anesthesiologist may infer treatment allocation based on patients' physiological responses; therefore, strict double-blinding is not feasible in this study. To minimize potential bias, allocation concealment and assessor blinding are implemented. Outcome data are collected and evaluated by study personnel who are not involved in anesthesia administration.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years
- •Patients scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP)
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Body mass index (BMI) between 18.5 and 30 kg/m²
- •Patients requiring sedation for ERCP
- •Ability to provide written informed consent voluntarily
排除标准
- •Allergy or contraindication to propofol, esketamine, sufentanil, or related medications
- •Severe hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg)
- •Severe dysfunction of the heart, lungs, liver, or kidneys
- •History of central nervous system disorders or psychiatric disorders
- •Anticipated difficult airway
- •History of psychiatric disorders or contraindications to ketamine use
- •Inability to communicate or provide informed consent
- •Requirement for general anesthesia with endotracheal intubation or intraoperative conversion to general anesthesia with intubation
研究组 & 干预措施
Esketamine arm
Participants receive intravenous esketamine in combination with propofol for procedural sedation during ERCP. Esketamine is administered as an adjunct analgesic during induction of sedation, while propofol is continuously infused and titrated according to clinical sedation requirements.
干预措施: Esketamine (Drug)
Sufentanil arm
Participants receive intravenous sufentanil in combination with propofol for procedural sedation during ERCP. Sufentanil is administered as an adjunct analgesic during induction of sedation, while propofol is continuously infused and titrated according to clinical sedation requirements.
干预措施: Sufentanil (Drug)
结局指标
主要结局
Incidence of intraoperative hypoxemia
时间窗: Six time points:T0, upon arrival in the procedure room (baseline); T1, after anesthesia induction; T2, when the endoscope passed the vocal cords; T3, when the endoscope passed the duodenal papilla; T4, at the end of the procedure; and T5, upon recovery.
Hypoxemia is defined as peripheral oxygen saturation (SpO₂) \< 90% lasting ≥ 10 seconds. Peripheral oxygen saturation (SpO₂) were recorded at six predefined time points: T0, T1, T2, T3, T4, T5.
次要结局
- Incidence of intraoperative hypotension(Six time points:T0, upon arrival in the procedure room (baseline); T1, after anesthesia induction; T2, when the endoscope passed the vocal cords; T3, when the endoscope passed the duodenal papilla; T4, at the end of the procedure; and T5, upon recovery.)
研究者
Ren Da
Attending Anesthesiologist
Beijing Friendship Hospital