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

NCT ID: NCT02867930

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-12-30

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

Conditions

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Heart Valve Disease Heart Septal Defects, Atrial

Keywords

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Echocardiography Transesophageal Dexmedetomidine Ketamine Propofol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

drug for moderate sedation in trans-esophageal echocardiography

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

Group Type ACTIVE_COMPARATOR

Ketofol(ketamine+propofol)

Intervention Type DRUG

drug for moderate sedation in trans-esophageal echocardiography

Interventions

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Dexmedetomidine

drug for moderate sedation in trans-esophageal echocardiography

Intervention Type DRUG

Ketofol(ketamine+propofol)

drug for moderate sedation in trans-esophageal echocardiography

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Sruthi Sankar

Post graduate student Junior resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sruthi Sankar

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

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Postgraduate Institute of Medical Education and Research

Chandigarh, , India

Site Status

Countries

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India

Other Identifiers

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KDTEE16

Identifier Type: -

Identifier Source: org_study_id