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

Phase 4

Completed

• Conditions: Heart Valve Disease; Heart Septal Defects, Atrial
• Interventions: Drug: Ketofol(ketamine+propofol); Drug: Dexmedetomidine

• Registration Number: NCT02867930
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-08-13
• Study First Posted: 2016-08-16
• Primary Completion: 2016-12
• Study Completion: 2016-12-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with Atrial septal defect/Valvular Heart disease (MS/MR/AS/AR)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group KF	Ketofol(ketamine+propofol)	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 D	Dexmedetomidine	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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,

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India