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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

Tracking Information
First Submitted Date  ICMJE June 30, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE June 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography
Official Title  ICMJE Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Out-patients Undergoing Diagnostic Trans-esophageal Echocardiography: A Randomized Controlled Trial
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Heart Valve Disease
  • Heart Septal Defects, Atrial
Intervention  ICMJE
  • Drug: Dexmedetomidine
    drug for moderate sedation in trans-esophageal echocardiography
  • Drug: Ketofol(ketamine+propofol)
    drug for moderate sedation in trans-esophageal echocardiography
Study Arms  ICMJE
  • 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
    Intervention: Drug: Dexmedetomidine
  • 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
    Intervention: Drug: Ketofol(ketamine+propofol)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02867930
Other Study ID Numbers  ICMJE KDTEE16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sruthi Sankar, Postgraduate Institute of Medical Education and Research, Chandigarh
Study Sponsor  ICMJE Postgraduate Institute of Medical Education and Research, Chandigarh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sruthi Sankar Postgraduate Institute of Medical Education and Research, Chandigarh
PRS Account Postgraduate Institute of Medical Education and Research, Chandigarh
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP