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Heart Valve DiseasePhase 4KDTEENCT02867930

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

A Phase 4 study testing Dexmedetomidine and Ketofol(ketamine+propofol) in people with Heart Valve Disease and Heart Septal Defects, Atrial, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Dexmedetomidine and Ketofol(ketamine+propofol)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIndia
Study dates
Jun 2016to 30 Dec 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • H/o GI surgery or H/o dysphagia
  • Restriction of neck mobility
  • Active esophagitis/peptic ulcer disease
  • Symptomatic bradycardia
  • Seizure disorder
  • Coagulopathy/thrombocytopenia

Trial locations and contacts

1 site in 1 country.

India1 site

  • Postgraduate Institute of Medical Education and Research

    Chandigarh, 160012

Other trials in India

About this study

Official title: Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Out-patients Undergoing Diagnostic Trans-esophageal Echocardiography: A Randomized Controlled Trial

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.

Read the 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

Being tested
Dexmedetomidine, Ketofol(ketamine+propofol)
Keywords
Echocardiography, Transesophageal, Dexmedetomidine, Ketamine, Propofol
Medical subject headings
Heart Valve Diseases, Heart Septal Defects, Atrial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    drug for moderate sedation in trans-esophageal echocardiography

  • Ketofol(ketamine+propofol)Drug

    drug for moderate sedation in trans-esophageal echocardiography

Study groups in NCT02867930
Study groupRoleWhat they receive
Group DActive comparatorDexmedetomidine- 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
Receives: Drug: Dexmedetomidine
Group KFActive comparatorKetamine+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
Receives: Drug: Ketofol(ketamine+propofol)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: maximum of 10 minutes

Secondary outcomes (5)

  1. Recovery time

    Time to achieve modified aldrete score >9

    Measured: Upto 30 minutes

  2. Heart rate during procedure

    Heart rate in beats/min, , facial pain score as 0-10

    Measured: every 5 minutes till end of procedure

  3. mean arterial pressure during procedure

    mean arterial pressure in mmHg,

    Measured: every 5 minutes till end of procedure

  4. Oxygen saturation during procedure

    oxygen saturation in %

    Measured: every 5 minutes till end of procedure

  5. End tidal carbondioxide during procedure

    End tidal carbon dioxide in mm Hg

    Measured: every 5 minutes till end of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionDec 2016
  4. Study completion30 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02867930
Sponsor's protocol ID
KDTEE16
Acronym
KDTEE
Status last verified
Nov 2017
First submitted
30 Jun 2016
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine and Ketofol(ketamine+propofol) in people with Heart Valve Disease and Heart Septal Defects, Atrial, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time taken to achieve adequacy of sedation before probe insertion. (time frame: maximum of 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02867930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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