NCT01819012

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 2, 2016

Status Verified

October 1, 2016

Enrollment Period

8 months

First QC Date

March 22, 2013

Last Update Submit

October 31, 2016

Conditions

Valvular Heart DiseaseIschemic Heart Disease

Keywords

Isofluranemitral valve annular velocitytissue Doppler imagingMonitoringechocardiography

Outcome Measures

Primary Outcomes (1)

  • Peak mitral annular velocity during systole(S')

    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 isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC (T1, T2 and T3, respectively)

    after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

Secondary Outcomes (6)

  • ejection fraction(EF)

    after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

  • bispectral index(BIS)

    after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

  • peak velocity of mitral inflow during early relaxation(E)

    after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

  • peak velocity of mitral inflow during atrial contraction(A)

    after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

  • Peak mitral annular velocity during early diastole(E')

    after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC

  • +1 more secondary outcomes

Study Arms (3)

Isoflurane 1.0 MAC

EXPERIMENTAL

10 min-inhalation of each concentration of isoflurane, 1.0 MAC

Drug: Isoflurane 1.0 MAC

Isoflurane 1.5 MAC

EXPERIMENTAL

10 min-inhalation of each concentration of isoflurane, 1.5 MAC

Drug: Isoflurane 1.5 MAC

Isoflurane 2.0 MAC

EXPERIMENTAL

10 min-inhalation of each concentration of isoflurane, 2.0 MAC

Drug: Isoflurane 2.0 MAC

Interventions

Isoflurane 1.0 MACDRUG

10 min-inhalation of each concentration of isoflurane, 1.0 MAC

Isoflurane 1.0 MAC
Isoflurane 1.5 MACDRUG

10 min-inhalation of each concentration of isoflurane, 1.5 MAC

Isoflurane 1.5 MAC
Isoflurane 2.0 MACDRUG

10 min-inhalation of each concentration of isoflurane, 2.0 MAC

Isoflurane 2.0 MAC

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
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, 143-729, South Korea

Location

Related Publications (1)

  • Kim JD, Son I, Kwon WK, Sung TY, Sidik H, Kim K, Kang H, Bang J, Yeo GE, Lee DK, Kim TY. Isoflurane's Effect on Intraoperative Systolic Left Ventricular Performance in Cardiac Valve Surgery Patients. J Korean Med Sci. 2018 Jan 22;33(4):e28. doi: 10.3346/jkms.2018.33.e28.

    PMID: 29318795DERIVED

MeSH Terms

Conditions

Heart Valve DiseasesMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Tae-Yop Kim, MD, PhD

    Konkuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

March 22, 2013

First Posted

March 27, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2013

Study Completion

March 1, 2014

Last Updated

November 2, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)