Heart Septal Defects, Atrial, Heart Valve Disease
Conditions
Keywords
Echocardiography, Transesophageal, Dexmedetomidine, Ketamine, Propofol
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 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
Interventions
DRUGDexmedetomidine
drug for moderate sedation in trans-esophageal echocardiography
DRUGKetofol(ketamine+propofol)
drug for moderate sedation in trans-esophageal echocardiography
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
India
Outcome results
None listed