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

Primary Purpose

Heart Valve Disease, Heart Septal Defects, Atrial

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Dexmedetomidine
Ketofol(ketamine+propofol)
Sponsored by
Postgraduate Institute of Medical Education and Research, Chandigarh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Valve Disease focused on measuring Echocardiography, Transesophageal, Dexmedetomidine, Ketamine, Propofol

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Postgraduate Institute of Medical Education and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group D

Group KF

Arm 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

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

Outcomes

Primary Outcome Measures

Time taken to achieve adequacy of sedation before probe insertion.
Adequacy of sedation to be measured using Ramsay Sedation Scale (>=3 considered adequate for probe insertion)

Secondary Outcome Measures

Recovery time
Time to achieve modified aldrete score >9
Heart rate during procedure
Heart rate in beats/min, , facial pain score as 0-10
mean arterial pressure during procedure
mean arterial pressure in mmHg,
Oxygen saturation during procedure
oxygen saturation in %
End tidal carbondioxide during procedure
End tidal carbon dioxide in mm Hg

Full Information

First Posted
June 30, 2016
Last Updated
November 2, 2017
Sponsor
Postgraduate Institute of Medical Education and Research, Chandigarh
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1. Study Identification

Unique Protocol Identification Number
NCT02867930
Brief Title
Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography
Acronym
KDTEE
Official Title
Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Out-patients Undergoing Diagnostic Trans-esophageal Echocardiography: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research, Chandigarh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Disease, Heart Septal Defects, Atrial
Keywords
Echocardiography, Transesophageal, Dexmedetomidine, Ketamine, Propofol

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sruthi Sankar
Organizational Affiliation
Postgraduate Institute of Medical Education and Research, Chandigarh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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