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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
Sponsor:
Information provided by (Responsible Party):
Sruthi Sankar, Postgraduate Institute of Medical Education and Research, Chandigarh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Valve Disease Heart Septal Defects, Atrial Drug: Dexmedetomidine Drug: Ketofol(ketamine+propofol) Phase 4

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


Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
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
 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
 Drug: Ketofol(ketamine+propofol)
drug for moderate sedation in trans-esophageal echocardiography


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Recovery time [ Time Frame: Upto 30 minutes ]
    Time to achieve modified aldrete score >9

  2. Heart rate during procedure [ Time Frame: every 5 minutes till end of procedure ]
    Heart rate in beats/min, , facial pain score as 0-10

  3. mean arterial pressure during procedure [ Time Frame: every 5 minutes till end of procedure ]
    mean arterial pressure in mmHg,

  4. Oxygen saturation during procedure [ Time Frame: every 5 minutes till end of procedure ]
    oxygen saturation in %

  5. End tidal carbondioxide during procedure [ Time Frame: every 5 minutes till end of procedure ]
    End tidal carbon dioxide in mm Hg


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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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India
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research, Chandigarh
Investigators
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Principal Investigator: Sruthi Sankar Postgraduate Institute of Medical Education and Research, Chandigarh
More Information
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Responsible Party: Sruthi Sankar, Post graduate student Junior resident, Postgraduate Institute of Medical Education and Research, Chandigarh
ClinicalTrials.gov Identifier: NCT02867930     History of Changes
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

Keywords provided by Sruthi Sankar, Postgraduate Institute of Medical Education and Research, Chandigarh:
Echocardiography
Transesophageal
Dexmedetomidine
Ketamine
Propofol

Additional relevant MeSH terms:
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Heart Septal Defects
Heart Valve Diseases
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Propofol
Dexmedetomidine
Ketamine
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