A Randomized, Controlled Trial to Compare the Efficacy and Safety Profile of a Remimazolam-alfentanil Combination With a Propofol-alfentanil Combination for ERCP
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- The number of hypoxia
研究概览
简要总结
Moderate to deep levels of sedation and analgesia are required for ERCP. Propofol-based sedation is simple, easy to use, and effective, but is not without cardiovascular and respiratory adverse effects. The combination of remimazolam and alfentanil has shown promising results for sedation in other similar scenarios. The aim of this study was to compare the efficacy and safety of a standard propofol-alfentanil regimen with a remimazolam-alfentanil combination.
详细描述
What is already known about this topic is that propofol-based sedation techniques are effective for ERCP procedures but are not without cardiovascular and respiratory adverse effects.
- Title:A randomized, controlled trial to compare the efficacy and safety profile of a remimazolam-alfentanil combination with a propofol-alfentanil combination for ERCP.
- Research center: Single center.
- The Design of the study: Randomized, double-blind, controlled study.
- The population of the study: Age is between 18 and 85 years; ASA I-III levels; Patients undergone elective ERCP surgery, non-intubation patients;
- Sample size: Based on Akhondzadeh R et al. research, propofol based sedation resulted in 43% patients present oxygen desaturation, and assuming a 15% reduction in hypoxic events in remimazolam group. From this, we have estimated that oxygen desaturation rate will be 43% in the propofol group and 28 % in the remimazolam group. We have estimated that, with a sample size of 207 patients, the study will have 80% power to detect a significant difference using the log-rank test. We have estimated that the rate of dropout or withdrawal will be approximately 20%, and thus we plan to enroll 259 patients each group
- Interventions: Group remimazolam-alfentanil combination received 10 µg/kg alfentanil and 0.3mg/kg remimazolam over 30 seconds, followed by an infusion of remimazolam at 0.2 to 1 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, remimazolam 0.1mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed.
Group propofol-alfentanil combination received 10 µg/kg alfentanil and 1.5 to 2 mg/kg propofol over 30 seconds followed by an infusion of propofol at 2 to 6mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope,propofol 0.5mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed. 7. Outcome： Primary outcome： The occurrence of hypoxia, defined by any event of SpO2 (oxygen saturation measured by pulse oximetry) < 90% of any duration.
Secondary outcome： Number of events of hypoxia, defined as desaturation < 90%. The mean number of events during the procedure will be compared between the two groups.
Lowest recorded SpO2 during the procedure. Requirement of minor airway manoeuvres: jaw lift/jaw thrust, nasopharyngeal airway insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is between 18 and 85 years
- •ASA I-III levels;
- •Patients undergone elective ERCP surgery, non-intubation patients;
排除标准
- •Chronic pain with long-term use of analgesics, psychotropic substances (including opioids, NSAIDs, sedatives, antidepressants), alcohol abusers, with known drug allergy;
- •BMI<18 or BMI>30;
- •Abnormal renal function ;
- •Previous abnormal surgical anesthesia recovery history;
- •Hypertension or systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg when the patient admission to the operating room
- •Sedatives, analgesics and antipruritic drugs were used 24 hours before operation;
- •Expected difficult intubation ;
- •Opioids allergy history;
- •Take monoamine oxidase inhibitor or antidepressant within 15 days;
- •Pregnant or parturient women;
- •Involved in other drug trials within three months;
- •Patients who can not communicate well with the researcher
研究组 & 干预措施
remimazolam-alfentanil combination
Group remimazolam-alfentanil combination received 10 µg/kg alfentanil and 0.3mg/kg remimazolam over 30 seconds, followed by an infusion of remimazolam at 0.2 to 1 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, remimazolam 0.1mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed
干预措施: remimazolam-alfentanil combination (Drug)
propofol-alfentanil combination
Group propofol-alfentanil combination received 10 µg/kg alfentanil and 1.5 to 2mg/kg propofol over 30 seconds followed by an infusion of propofol at 2 to 6 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, propofol 0.5 mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed
干预措施: propofol-alfentanil combination (Drug)
结局指标
主要结局
The number of hypoxia
时间窗: 1 day
defined by any event of SpO2 (oxygen saturation measured by pulse oximetry) \< 90% of any duration.
次要结局
- Sensation of abdominal bloating(1-3 days)
- Lowest recorded SpO2 during the procedure(1 day)
- the number of requirement for minor airway manoeuvres(1 day)
- Requirement of antispasmodic agent(1 day)
- Rescued sedation:(1 day)
- Duration under sedation/anaesthesia(1day)
- Successful completion of the procedure(1 day)
- Number of events of hypoxia, defined as desaturation < 90%.(1 day)
- Endoscope re-insertion rate(1 day)
- Total duration of procedure(1 day)
- quality of recovery score-15(1-3 days)
- the number of requirement for major airway manoeuvres(1 day)
- Total alfentanyl dose(1 day)
- Patients' satisfaction score on leaving recovery(1-3 days)
- The endoscopist assessed the ease of performing at the end of the procedure as I-satisfactory, II-difficult or III-impossible(1 days)
- Recovery time(1 day)
研究者
Jianbo Yu
Director
Tianjin Nankai Hospital