NCT02867930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

June 30, 2016

Last Update Submit

November 2, 2017

Conditions

Heart Valve DiseaseHeart Septal Defects, Atrial

Keywords

EchocardiographyTransesophagealDexmedetomidineKetaminePropofol

Outcome Measures

Primary Outcomes (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)

    maximum of 10 minutes

Secondary Outcomes (5)

  • Recovery time

    Upto 30 minutes

  • Heart rate during procedure

    every 5 minutes till end of procedure

  • mean arterial pressure during procedure

    every 5 minutes till end of procedure

  • Oxygen saturation during procedure

    every 5 minutes till end of procedure

  • End tidal carbondioxide during procedure

    every 5 minutes till end of procedure

Study Arms (2)

Group D

ACTIVE COMPARATOR

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

Group KF

ACTIVE COMPARATOR

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)

Interventions

DexmedetomidineDRUG

drug for moderate sedation in trans-esophageal echocardiography

Group D
Ketofol(ketamine+propofol)DRUG

drug for moderate sedation in trans-esophageal echocardiography

Group KF

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Heart Valve DiseasesHeart Septal Defects, Atrial

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sruthi Sankar

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduate student Junior resident

Study Record Dates

First Submitted

June 30, 2016

First Posted

August 16, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 30, 2016

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

IN(1)