BIS guided comparision of procedural sedation for endoscopic retrograde cholangiopancreatography (ERCP)using propofol with ketamine versus dexmedetomidine with ketamine based infusion.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare two regimens based on depth of anesthesia using bi spectral index(BIS).
研究概览
简要总结
The study compares the efficacy and safety of two sedation protocols guided by Bispectral Index (BIS) monitoring for endoscopic retrograde cholangiopancreatography (ERCP): propofol with ketamine versus dexmedetomidine with ketamine infusion. Both protocols aim to optimize sedation depth while minimizing adverse events. By analyzing factors such as sedation efficacy, procedural success rates, patient satisfaction, recovery times, hemodynamic stability, respiratory parameters, and cost-effectiveness, the study seeks to identify the optimal sedation strategy for ERCP. The findings will inform clinical practice and enhance patient outcomes in ERCP procedures.
A prospective, hospital based, randomised control trial study including a sample size of 90 patients in a time period between April 2023 to October 2024.
Data will be collected by using self design questionnaire and observational findings during procedure.
Entire data would be entered into a Microsoft office software and appropriate stastical test will be applied and results will be calculated.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA grade 1 and 11 2.Age between 18years to 65 years scheduled for ERCP 3.All genders.
排除标准
- •Patient with preexisting cardiac disease(congestive heart failure,coronary heart disese) 2.Severe renal dysfunction 3.Pregnancy 4.Lactating females 5.Patient with known allergy to drugs 6.Hypertension 7.Increased intracranial tension.
结局指标
主要结局
To compare two regimens based on depth of anesthesia using bi spectral index(BIS).
时间窗: To compare two regimens based on depth of anesthesia using bi spectral index(BIS).
次要结局
- To assess the quality of anesthesia in terms of hemodynamic stability, pain relief and surgeon’s satisfaction between groups.
研究者
dr rohit pareek
mahatma gandhi medical college and hospital