NCT02003885

Brief Summary

The purpose of this study is to determine desflurane's dose-dependent effect on left ventricular (LV) function in cardiac surgery. The change of tissue Doppler imaging (TDI) of lateral mitral valve annular velocity at three different desflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE) in cardiac surgery patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

August 28, 2013

Last Update Submit

March 4, 2015

Conditions

Keywords

Desflurane, mitral annular velocity, tissue Doppler imaging

Outcome Measures

Primary Outcomes (1)

  • Peak systolic mitral annular velocity (S')

    Peak systolic mitral annular velocity (S') using tissue Doppler imaging By using pulsed Doppler with the sample volume positioned at the lateral mitral valve (MV)ring in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of desflurane, 0.5 MAC, 1.0 MAC and 1.5 MAC (T1, T2 and T3, respectively)

    after 10 min exposure to desflurane 0.5, 1.0 and 1.5 MAC

Secondary Outcomes (1)

  • diastolic mital annular veocities (E' and A'), ejection fraction (EF), Bispectral index

    after 10 min exposure to desflurane 0.5, 1.0 and1.5 MAC

Study Arms (1)

Desflurane increment

EXPERIMENTAL

increment of desflurane 0.5-1.5 MAC in remifentanil anesthesia for cardiac surgery

Drug: increment of desflurane

Interventions

After achieving stable hemodynamics and BIS 40-60 with desflurnae 0.5 MAC and remifentanil 0.7-1.0 mcg/kg/min (T1), data including S', E', A', EF, E, A and BIS are determined. After 10 min exposure to the increased desflurane dosage 1.0 MAC (T2), data are determiend. After 10 min exposure to the increased desflurane dosage 1.5 MAC (T3), data are determined. Reduction of BP is managed by the increment of phenylephrine infusion

Also known as: Desflurane inhalation 0.5 MAC, 1.0 MAC and 1.5 MAC
Desflurane increment

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing cardiac surgery

You may not qualify if:

  • Low ejection fraction \<50% in preoperative transthoracic echocardiography
  • Atrial fibrillation
  • Pacemaker
  • Pericardial and infiltrative myocardial disease
  • Mitral annular calcification, surgical rings, prosthetic mitral valves
  • Lateral left ventricular regional wall motion abnormality
  • Esophageal spasm, stricture, laceration, perforation, and diverticulum
  • Diaphragmatic hernia
  • History of extensive radiation to mediastinum
  • Upper gastrointestinal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Medical Center

Seoul, Seoul, 143729, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Tae-Yop Kim, MD, PhD

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tae-Yop Kim, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

August 28, 2013

First Posted

December 6, 2013

Study Start

January 1, 2014

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations