CTRI/2025/11/098180招募中4 期
Effect of Dexmedetomidine vs Ketamine infusion on the performance of propofol based closed loop anaesthesia delivery system for controlling depth of sedation in patients undergoing endoscopic retrograde cholangiopancreatography: a parallel arm randomised controlled study
Postgraduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月15日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the percentage of valid CLADS time Bispectral Index (BIS) values remain within the target range 60 ± 10 during sedation maintained by Closed Loop Anaesthesia Delivery System for propofol when supplemented with dexmedetomidine versus ketamine.
研究概览
简要总结
This study will assess the anaesthetic depth control using CLADS based on propofol sedation using two interventions. First is the combination of propofol-CLADS with dexmedetomidine infusion and the second is the combination with ketamine infusion. The target BIS for propofol-CLADS will be 60 ± 10.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than equal to 18 Procedural duration more than 20 min.
排除标准
- •Patients failing to achieve MOAAS less than 2 when BIS of 60 is achieved Age more than 80 BMI more than 35 History of snoring or OSA Allergy to any study drug Hemodynamic instability requiring vasopressors LVEF less than 25 percent.
结局指标
主要结局
To compare the percentage of valid CLADS time Bispectral Index (BIS) values remain within the target range 60 ± 10 during sedation maintained by Closed Loop Anaesthesia Delivery System for propofol when supplemented with dexmedetomidine versus ketamine.
时间窗: During the ERCP procedural sedation
次要结局
- Percentage of the valid CLADS time for which BIS remains in the range of 60 ± 5.(During the ERCP procedural sedation)
- Performance error(During the ERCP procedural sedation)
- Median performance error(During the ERCP procedural sedation)
- Median absolute performance error(During ERCP procedural sedation)
- Global score(During the ERCP procedural sedation)
- Wobble(During the ERCP procedural sedation)
- Hemodynamic stability – any fall or increase in blood pressure or heart rate ± 25% of the baseline parameters(During the ERCP procedural sedation)
- Duration for which heart rate or blood pressure remains ± 25% of the baseline(During the ERCP procedural sedation)
- Episodes of apnea requiring intervention to maintain the airway(During the ERCP procedural sedation)
- Total propofol used (mg and mg/kg)(During the ERCP procedural sedation)
- Plasma target concentration of propofol (Marsh model) required to achieve BIS 60(During the ERCP procedural sedation)
- Plasma concentration of propofol required to achieve a BIS of 60(During the ERCP procedural sedation)
- Total dexmedetomidine used (µg and µg/kg)(During the ERCP procedural sedation)
- Total ketamine used in mg and mg/kg(During the ERCP procedural sedation)
- Time to awakening in minutes(During the ERCP procedural sedation)
- Patient discomfort during the procedure(During the ERCP procedural sedation)
- Need to give additional intravenous bolus of the study drugs(During the ERCP procedural sedation)
研究者
Varun Mahajan
Postgraduate Institute of Medical Education and Research
研究点 (1)
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