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

Sponsor

Postgraduate Institute of Medical Education and Research, Chandigarh (Other)

Overall Status

Completed

CT.gov ID

NCT02867930

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Valve Disease Heart Septal Defects, Atrial	Drug: Dexmedetomidine Drug: Ketofol(ketamine+propofol)	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Dexmedetomidine drug for moderate sedation in trans-esophageal echocardiography
Active Comparator: 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	Drug: Ketofol(ketamine+propofol) drug for moderate sedation in trans-esophageal echocardiography

Arm

Intervention/Treatment

Active Comparator: 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

Drug: Dexmedetomidine

drug for moderate sedation in trans-esophageal echocardiography

Active Comparator: 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

Drug: Ketofol(ketamine+propofol)

drug for moderate sedation in trans-esophageal echocardiography

Outcome Measures

Primary Outcome Measures

Time taken to achieve adequacy of sedation before probe insertion. [maximum of 10 minutes]
Adequacy of sedation to be measured using Ramsay Sedation Scale (>=3 considered adequate for probe insertion)

Secondary Outcome Measures

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