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

Study Overview
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Brief Summary
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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 Description
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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

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

Conditions
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Heart Valve Disease, Heart Septal Defects, Atrial

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Ketofol(ketamine+propofol)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Atrial septal defect/Valvular Heart disease (MS/MR/AS/AR) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group D<br>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<br>* drug for moderate sedation in trans-esophageal echocardiography<br>|
| Active Comparator: Group KF<br>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)<br>* drug for moderate sedation in trans-esophageal echocardiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken to achieve adequacy of sedation before probe insertion. | Adequacy of sedation to be measured using Ramsay Sedation Scale (>=3 considered adequate for probe insertion) | maximum of 10 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Echocardiography, Transesophageal, Dexmedetomidine, Ketamine, Propofol