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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 4

Conditions: Heart Septal Defects, Atrial; Heart Valve Disease

Treatments: Drug: Ketofol(ketamine+propofol); Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02867930

KDTEE16

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Group D

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

Group KF

Active Comparator group

Description:

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

Treatment:

Drug: Ketofol(ketamine+propofol)