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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02867930
Other study ID # KDTEE16
Secondary ID
Status Completed
Phase Phase 4
First received June 30, 2016
Last updated November 2, 2017
Start date June 2016
Est. completion date December 30, 2016

Study information

Verified date November 2017
Source Postgraduate Institute of Medical Education and Research, Chandigarh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 30, 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Intervention

Drug:
Dexmedetomidine
drug for moderate sedation in trans-esophageal echocardiography
Ketofol(ketamine+propofol)
drug for moderate sedation in trans-esophageal echocardiography

Locations

Country Name City State
India Postgraduate Institute of Medical Education and Research Chandigarh

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Institute of Medical Education and Research, Chandigarh

Country where clinical trial is conducted

India, 

Outcome

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