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

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.

Study Overview

• Status: Completed
• Conditions: Heart Septal Defects, Atrial; Heart Valve Disease
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Ketofol(ketamine+propofol)

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: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Postgraduate Institute of Medical Education and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Dexmedetomidine; drug for moderate sedation in trans-esophageal echocardiography
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	Drug: Ketofol(ketamine+propofol); drug for moderate sedation in trans-esophageal echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	maximum of 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time	Time to achieve modified aldrete score >9	Upto 30 minutes
Heart rate during procedure	Heart rate in beats/min, , facial pain score as 0-10	every 5 minutes till end of procedure
mean arterial pressure during procedure	mean arterial pressure in mmHg,	every 5 minutes till end of procedure
Oxygen saturation during procedure	oxygen saturation in %	every 5 minutes till end of procedure
End tidal carbondioxide during procedure	End tidal carbon dioxide in mm Hg	every 5 minutes till end of procedure

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research, Chandigarh
• Investigators: Principal Investigator: Sruthi Sankar, Postgraduate Institute of Medical Education and Research, Chandigarh

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 30, 2016

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: August 13, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Ketamine; Propofol; Dexmedetomidine; Echocardiography; Transesophageal
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Heart Septal Defects, Atrial; Heart Valve Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Ketamine; Propofol; Dexmedetomidine
• Other Study ID Numbers: KDTEE16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED