Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Acute physiology and chronic health evaluation IIScore sheet
研究概览
简要总结
Increased production of vasodilating substances such as NO plays an important role in the development of vasoplegic syndrome caused by obstructive jaundice.Methylene blue plays a role in raising blood pressure by inhibiting the vasodilator Nitric Oxide (NO)
详细描述
The level of circulating hydrogen sulfide (H2S) in patients with obstructive jaundice is significantly increased. As a direct opener of KATP channels in vivo, H2S also has diastolic peripheral vasculature . H2S participates in the occurrence of vasoplegic syndrome in patients with obstructive jaundice by interacting with NO. However, it is unclear whether methylene blue can relieve vasoplegic syndrome in patients with obstructive jaundice by inhibiting the vasodilating effect of substances such as H2S and NO.
Therefore, this clinical study intends to include patients with obstructive jaundice, using randomized, controlled, prospective study to explore the effect of methylene blue on the occurrence of vasoplegic syndrome, organ function and prognosis in patients with obstructive jaundice.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18~70 years old;
- •ASA grade I~III;
- •Ability to comply with research protocols;
- •Patients with obstructive jaundice: patients with total bilirubin greater than 50umol/L;
- •Voluntarily participate in the study and sign the informed consent form. -
排除标准
- •ASA IV~V grade;
- •women during lactation and pregnancy;
- •Patients with severe heart disease or lung disease before surgery;
- •Participating in other trials in the last 2 months;
- •Those whose mental state cannot cooperate, who suffer from mental illness, have no self-control, and cannot express clearly;
- •Those who refuse to sign the informed consent form. -
研究组 & 干预措施
Methylene blue group
Before the anesthesia was intubated, the patients in the methylene blue group were given a 2 mg/Kg methylene blue 50 ml intravenously for 10 min; continuous constant speed pumping methylene blue(0.5mg/Kg/h).
干预措施: Methylene Blue (Drug)
Placebo group
Before the anesthesia was intubated, the placebo group was given 50 ml of normal saline for 10 min.continuous constant speed pumpingnormal saline (10ml/h).
干预措施: Saline (Drug)
结局指标
主要结局
Acute physiology and chronic health evaluation IIScore sheet
时间窗: 3 days
use this Score sheet to evaluation of postoperative organ function in patients.The total score is 0 to 71
次要结局
未报告次要终点
研究者
Jiaolin Ning,MD
Professor of department of anesthesia
Southwest Hospital, China