Clinical Trial: Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Out-patients Undergoing Diagnostic Trans-esophageal Echocardiography: A Randomized Controlled Trial

Brief Summary: 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.

Detailed Summary:

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


Sponsor: Postgraduate Institute of Medical Education and Research, Chandigarh

Current Primary Outcome: Time taken to achieve adequacy of sedation before probe insertion. [ Time Frame: maximum of 10 minutes ]

Adequacy of sedation to be measured using Ramsay Sedation Scale (>=3 considered adequate for probe insertion)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Recovery time [ Time Frame: Upto 30 minutes ]
    Time to achieve modified aldrete score >9
  • Heart rate during procedure [ Time Frame: every 5 minutes till end of procedure ]
    Heart rate in beats/min, , facial pain score as 0-10
  • mean arterial pressure during procedure [ Time Frame: every 5 minutes till end of procedure ]
    mean arterial pressure in mmHg,
  • Oxygen saturation during procedure [ Time Frame: every 5 minutes till end of procedure ]
    oxygen saturation in %
  • End tidal carbondioxide during procedure [ Time Frame: every 5 minutes till end of procedure ]
    End tidal carbon dioxide in mm Hg


Original Secondary Outcome: Same as current

Information By: Postgraduate Institute of Medical Education and Research, Chandigarh

Dates:
Date Received: June 30, 2016
Date Started: June 2016
Date Completion:
Last Updated: August 13, 2016
Last Verified: August 2016