CTRI/2024/08/072483招募中4 期
Comparison Study Of Recovery Characteristics And Clinical Effect Of Ketamine Vs Fentanyl As An Adjuvant To Propofol And Midazolam In Dilatation And Curettage : A Randomized Double-Blind Interventional Study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- To compare difference in Mean Modified Aldrete’s score & post-operatively and mean recovery time taken.
研究概览
简要总结
In this study, two sedation protocols prepared by adding fentanyl or ketamine to the combination of midazolam-propofol applied on Dilatation & curettage will be compared with respect to patient satisfaction, side effects, and the technical characteristics such as the duration of the procedure and the total propofol consumption.
MEASURING INDICATOR:
Modified Aldrete’s score , Visual Analog Scale , Ramsay sedation scale, Time duration taken for need for first rescue analgesia.
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
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA physical status classification I- II
- •Patients who were scheduled for Dilation & Curettage procedures.
排除标准
- •ASA physical status class III-IV
- •Allergic to study drugs
- •Patients denying consent for study.
- •Body mass index ≥ 35 kg/m
- •Chronic use of sedatives or opioid analgesics, and presence of a psychiatric disorder with chronic medical treatment, presence of liver or kidney dysfunctions, cardiac and endocrine diseases .
- •Non-cooperative patients.
结局指标
主要结局
To compare difference in Mean Modified Aldrete’s score & post-operatively and mean recovery time taken.
时间窗: AT 30 min, 1hour , 2 hour, 4 hrs & 6 hrs
次要结局
- 1) To evaluate difference in change in hemodynamic parameters during intra-operative from baseline(2) To assess difference in mean time duration taken for need for first rescue analgesia in both group.)
研究者
Dr Rajnikant Shandilya
Heritage Institute of medical Sciences, varanasi
研究点 (1)
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