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

Heart Valve Disease Clinical Trial

— KDTEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867930
• Other study ID #: KDTEE16
• 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
• 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

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Atrial
• Heart Valve Disease
• Heart Valve Diseases

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