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

Ketamine

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.

Intervention / Treatment

  • Dexmedetomidine (DRUG)
    drug for moderate sedation in trans-esophageal echocardiography
  • Ketofol(ketamine+propofol) (DRUG)
    drug for moderate sedation in trans-esophageal echocardiography

Condition or Disease

  • Heart Valve Disease
  • Heart Septal Defects, Atrial

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 60 Years
    Enrollment: 50 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jun 01, 2016
    Primary Completion: Dec 01, 2016 ACTUAL
    Completion Date: Dec 30, 2016 ACTUAL
    Study First Posted: Aug 16, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 02, 2017

    Sponsors / Collaborators

    Lead Sponsor: Postgraduate Institute of Medical Education and Research, Chandigarh
    Responsible Party: N/A

    Location

    Chandigarh, India

    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

    Participant Groups

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 60
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Adequacy of sedation to be measured using Ramsay Sedation Scale (\>=3 considered adequate for probe insertion)

    Secondary Outcomes

    • Time to achieve modified aldrete score \>9

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

    • mean arterial pressure in mmHg,

    • oxygen saturation in %

    • End tidal carbon dioxide in mm Hg

    More Details

    NCT Number: NCT02867930
    Acronym: KDTEE
    Other IDs: KDTEE16
    Study URL: https://clinicaltrials.gov/study/NCT02867930
    Last updated: Sep 29, 2023