Comparison of mean blood pressure variability in conox-guided total intravenous anaesthesia and closed-loop anaesthesia delivery system in adult patients undergoing elective laparoscopic surgery: a randomized control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- To evaluate intraoperative hemodynamic stability, specifically mean arterial pressure (MAP), during elective laparoscopic surgeries, with a target MAP variation of ±25% from baseline in CONOX-guided Total Intravenous Anaesthesia (TIVA) and BIS-monitored Closed-Loop Anesthesia Delivery Systems (CLADS).
研究概览
简要总结
This study is a randomized, double blinded, single centre trial comparing the mean blood pressure variability in CONOX guided TIVA and CLADS based TIVA in patients undergoing elective laparoscopic surgery that will be conducted in DNT OT of AIIMS Jodhpur over a period of 1 year. The primary outcome is to evaluate intraoperative heomdynamic variability as measured by Mean Arterial Pressure in both groups. Secondary outcomes would be heart rate variability, time to extubation, modified aldrete score, propofol and fentanyl drug consumption, incidence of PONV in both groups. Both primary and secondary outcomes will be assessed after a period of 1 year for 52 cases for each group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients ( more than 18 years) b.
- •Undergoing elective laparoscopic surgery requiring general anesthesia for more than 120 minutes c.
- •ASA (American society of anesthesiologists) physical status 1-3.
排除标准
- •Known allergies to propofol, fentanyl, or other anesthetics b.
- •Significant cardiovascular, respiratory, neurological disorders, or uncontrolled endocrine diseases c.
- •Pregnant or lactating women.
结局指标
主要结局
To evaluate intraoperative hemodynamic stability, specifically mean arterial pressure (MAP), during elective laparoscopic surgeries, with a target MAP variation of ±25% from baseline in CONOX-guided Total Intravenous Anaesthesia (TIVA) and BIS-monitored Closed-Loop Anesthesia Delivery Systems (CLADS).
时间窗: Throughout duration of intraoperative period at 5 minutes intervals from induction to extubation, study to be conducted over a period of 1 year from date of approval.
次要结局
- 1. Heart Rate Variability:(To evaluate intraoperative heart rate variability (±25% from baseline) every 5 minutes as an indicator of autonomic stability & anesthetic effects.)
研究者
Dr Manoj Kamal
All India Institute of Medical Sciences Jodhpur