Heart Valve Disease Clinical Trial
Official title:
Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Out-patients Undergoing Diagnostic Trans-esophageal Echocardiography: A Randomized Controlled Trial
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.
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
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