Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography (KDTEE)
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ClinicalTrials.gov Identifier: NCT02867930 |
Recruitment Status :
Completed
First Posted : August 16, 2016
Last Update Posted : November 6, 2017
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Condition or disease | Intervention/treatment | Phase |
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Heart Valve Disease Heart Septal Defects, Atrial | Drug: Dexmedetomidine Drug: Ketofol(ketamine+propofol) | Phase 4 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Out-patients Undergoing Diagnostic Trans-esophageal Echocardiography: A Randomized Controlled Trial |
Study Start Date : | June 2016 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | December 30, 2016 |

Arm | Intervention/treatment |
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Active Comparator: 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
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Drug: Dexmedetomidine
drug for moderate sedation in trans-esophageal echocardiography |
Active Comparator: 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
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Drug: Ketofol(ketamine+propofol)
drug for moderate sedation in trans-esophageal echocardiography |
- Time taken to achieve adequacy of sedation before probe insertion. [ Time Frame: maximum of 10 minutes ]Adequacy of sedation to be measured using Ramsay Sedation Scale (>=3 considered adequate for probe insertion)
- Recovery time [ Time Frame: Upto 30 minutes ]Time to achieve modified aldrete score >9
- Heart rate during procedure [ Time Frame: every 5 minutes till end of procedure ]Heart rate in beats/min, , facial pain score as 0-10
- mean arterial pressure during procedure [ Time Frame: every 5 minutes till end of procedure ]mean arterial pressure in mmHg,
- Oxygen saturation during procedure [ Time Frame: every 5 minutes till end of procedure ]oxygen saturation in %
- End tidal carbondioxide during procedure [ Time Frame: every 5 minutes till end of procedure ]End tidal carbon dioxide in mm Hg

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867930
India | |
Postgraduate Institute of Medical Education and Research | |
Chandigarh, India, 160012 |
Principal Investigator: | Sruthi Sankar | Postgraduate Institute of Medical Education and Research, Chandigarh |
Responsible Party: | Sruthi Sankar, Post graduate student Junior resident, Postgraduate Institute of Medical Education and Research, Chandigarh |
ClinicalTrials.gov Identifier: | NCT02867930 |
Other Study ID Numbers: |
KDTEE16 |
First Posted: | August 16, 2016 Key Record Dates |
Last Update Posted: | November 6, 2017 |
Last Verified: | November 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Echocardiography Transesophageal Dexmedetomidine Ketamine Propofol |
Heart Septal Defects Heart Valve Diseases Heart Septal Defects, Atrial Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Dexmedetomidine Ketamine Propofol Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Intravenous |
Anesthetics, General Anesthetics Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anesthetics, Dissociative Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |