Efficacy and Safety Profile of Cisatracurium Besylate for Intra-abdominal Hypertensiona: Single Center, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- All-cause 28-day mortality
研究概览
简要总结
This study is a randomized, double-blinded, controlled design. In this study, Cisatracurium Besylate was selected for treatment in Intra-abdominal hypertension or abdominal compartment syndrome,accompanied with evaluating the effects on the duration of organ failure,length of hospital stay and mortality.To clarify the effect of Cisatracurium Besylate on IAH/ACS is of great significance to the clinical applications.
详细描述
- Title: Title: Efficacy and Safety Profile of Cisatracurium Besylate on Intra-abdominal hypertension: A Randomized Clinical Trial
- Research center: single center
- Design of the research: A randomized, double-blind and parallel controlled study
- Object of the research: The patients over 18 years that Intra-abdominal pressure over 12mmHg.
- Sample size of the research: A total of 80patients,40 cases in each group
- Interventions: Participants in the test group received Cisatracurium Besylate 0.12mg/kg/hr continuous infusion during intubation.while participants in the control group was the same as the test group except for received the same volume of saline instead of Cisatracurium Besylate.TOF-Watch was used to monitor the function of nerve and muscle in two groups and the dose was adjusted according to the TOF value.
- The aim of the research:To investigate the effect of Cisatracurium Besylate on IIntra-abdominal hypertension or abdominal compartment syndrome.
- Outcome #Primary outcomes: mortality. Secondary outcomes: Duration of organ failure; Time for enteral nutrition to reach the standard (30kcal/kg); Mechanical ventilation time; Length of hospital stay
- The estimated duration of the study#1-2years
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, Investigator)
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
- •Intra-abdominal pressure≥12mmHg
- •Age ≥18 years old
- •Obtain informed consent.
排除标准
- •Pregnancy pancreatitis
- •Patients who have undergone percutaneous puncture or surgical drainage before admission, and have undergone surgical decompression due to early abdominal hypertension
- •Patients with a history of chronic organ dysfunction (such as uremia, COPD, liver cirrhosis, heart failure, etc.)
- •Those who refuse to participate in the research
研究组 & 干预措施
test group
Participants in the test group received Cisatracurium Besilate 0.12mg/kg/hr Continuous infusion During intubation
干预措施: Cisatracurium Besylate (Drug)
control group
Participants in the control group received saline 0.12ml/kg/hr Continuous infusion During intubation
干预措施: saline 0.12ml/kg/hr (Drug)
结局指标
主要结局
All-cause 28-day mortality
时间窗: 1-2year
All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments
次要结局
- Duration of organ failure(an average of 1-2 year)
- Duration of mechanical ventilation in patients with endotracheal intubation in ICU(an average of 1 year)
- Length of stay in hospital(24 months)
研究者
Jianbo Yu
Department of anesthesiology , Director, Chief physician
Tianjin Nankai Hospital