Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Out-patients Undergoing Diagnostic Trans-esophageal Echocardiography: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time taken to achieve adequacy of sedation before probe insertion.
研究概览
简要总结
The purpose of the study is to compare dexmedetomidine and ketofol to find a suitable alternative for moderate sedation in out-patient diagnostic trans-esophageal echocardiography.
详细描述
Sample size was estimated based on previous studies with sedation in equally invasive procedures that in 2 groups difference in time to achieve Ramsay sedation scale was 0.8min.(In group dexmedetomidine 12.4 & group ketofol 13.2 with S.D of 0.8). The sample size came out to be 22 subjects per group at a power of 90 % & confidence interval of 95 %. For possible dropouts, it was decided to include 10% extra subjects so finally it was decided to include 25 subjects per group. (Total sample size 50 subjects)
Normality of quantitative data will be checked by measures of Kolmogorov Smirnov tests of normality. If data is normally distributed Student t-test will be applied for comparison of 2 groups. Mann-Whitney U-test will be used for statistical analysis of skewed continuous variables or ordered categorical data. Proportions will be compared using Chi square or Fisher's exact test whichever is applicable. Wilcoxon Signed rank test will be used for skewed data or for scores (time related variables). . For comparison (time related variables) of Hemodynamics Repeated Measure ANOVA will be applied. All statistical tests will be two-sided and will be performed at a significance level of α=0.05. Analysis will be conducted using SPSS for Windows
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Atrial septal defect/Valvular Heart disease (MS/MR/AS/AR)
排除标准
- •Atrial fibrillation with fast ventricular rate
- •Congestive cardiac failure
- •BMI > 30
- •Perforated viscus/active GI bleed
- •Esophageal stricture/tumor/laceration
- •H/o radiation to neck & mediastinum
- •H/o GI surgery or H/o dysphagia
- •Restriction of neck mobility
- •Active esophagitis/peptic ulcer disease
- •Symptomatic bradycardia
- •Seizure disorder
- •Coagulopathy/thrombocytopenia
研究组 & 干预措施
Group D
Dexmedetomidine- drug used for moderate sedation prepared as 200 mic in 20 ml syringe.with intravenous loading dose at 1ml/kg/hour till required sedation is achieved and maintenance infusion of 0.05mg/kg/hour till completion of transesophageal echocardiography
干预措施: Dexmedetomidine (Drug)
Group KF
Ketamine+Propofol -drugs used for sedation-as ratio 1:3with 19ml of 1% propofol + 1.3ml ketamine(50mg/ml) as loading intravenous infusion dose at 1ml/kg/hour till required sedation is achieved and maintenance infusion of 0.05mg/kg/hour till completion of transesophageal echocardiography
干预措施: Ketofol(ketamine+propofol) (Drug)
结局指标
主要结局
Time taken to achieve adequacy of sedation before probe insertion.
时间窗: maximum of 10 minutes
Adequacy of sedation to be measured using Ramsay Sedation Scale (\>=3 considered adequate for probe insertion)
次要结局
- Oxygen saturation during procedure(every 5 minutes till end of procedure)
- End tidal carbondioxide during procedure(every 5 minutes till end of procedure)
- Recovery time(Upto 30 minutes)
- Heart rate during procedure(every 5 minutes till end of procedure)
- mean arterial pressure during procedure(every 5 minutes till end of procedure)
研究者
Sruthi Sankar
Post graduate student Junior resident
Post Graduate Institute of Medical Education and Research, Chandigarh