Effects of Bispectral Index on Oxidative Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Effects of BIS on oxidative stress
研究概览
简要总结
Objective Endoscopic Retrograde Cholangiopancreatography (ERCP) is performed for resolving cholestasis by sphincterotomy and/or stone extraction and is done with deep sedation or general anesthesia. The investigators primary outcome was to evaluate the effects of the depth of anesthesia on oxidative stres provided via Bispectral Index (BIS) monitorisation during the ERCP procedure by analyzing the biochemical parameters. And their secondary outcome was the effects of anesthesia depth on propofol consumption and postoperative sedation status.
详细描述
50 patients undergoing ERCP procedure were randomly allocated in two groups. Propofol was given to provide the patients Ramsey sedation scale as 3 and 4 in Group R (n=25) patients whereas it was given to Group B (n=25) patients to provide BIS values between 65 to 85. The levels of total oxidant status (TOS), total antioxidant status (TAS), and Oxidative stres index (OSI) were measured. Hemodynamic signs, propofol consumption, postoperative recovery time were recorded.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with American Society of Anesthesiologists physical status I-II
- •Patients undergoing ERCP procedures
排除标准
- •uncontrolled comorbidities (hypertension, diabetes mellitus, kidney-liver failure)
- •difficulty in communication (language problems, such as deafness)
- •who are allergic to the drugs used
- •pregnant women
研究组 & 干预措施
Group R (Ramsey)=25 patients
Propofol infusion was administered to provide Ramsey Sedation Scale 3-4 in Group R
干预措施: Ramsey Sedation Scale (Other)
Group B (BIS)=25 patients
Propofol infusion was given to maintain the Bispectral index monitorisation (BIS) levels between 60 and 85 in Group B.
干预措施: Bispectral Index Monitorisation (BIS) (Device)
结局指标
主要结局
Effects of BIS on oxidative stress
时间窗: one day
The investigators aimed to investigate the effects of anesthesia with monitoring the depth of anesthesia using BIS on oxidative stres by measuring the total oxidant status (TAS) and total antioxidant status (TOS) , propofol consumption, and postoperative recovery during ERCP procedures in this study.
次要结局
未报告次要终点