Clinical trial NCT02867930: Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Valve Disease
Heart Septal Defects, Atrial
Keywords: Echocardiography
Transesophageal
Dexmedetomidine
Ketamine
Propofol
Lead sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Time taken to achieve adequacy of sedation before probe insertion.
timeFrame: maximum of 10 minutes
Secondary outcomes:
measure: Recovery time
timeFrame: Upto 30 minutes
measure: Heart rate during procedure
timeFrame: every 5 minutes till end of procedure
measure: mean arterial pressure during procedure
timeFrame: every 5 minutes till end of procedure
measure: Oxygen saturation during procedure
timeFrame: every 5 minutes till end of procedure
measure: End tidal carbondioxide during procedure
timeFrame: every 5 minutes till end of procedure
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Sruthi Sankar
role: PRINCIPAL_INVESTIGATOR
References: