Sevoflurane's Effect on Mitral Valve Annular Velocity in Cardiac Surgery

NCT ID: NCT01511991

Last Updated: 2015-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-05-31

Brief Summary

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The purpose of this study is to determine sevoflurane'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 sevoflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE)in cardiac surgery patients.

Detailed Description

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Following data would be determined after 10 min-exposure to each dosage of sevoflurane with 1.0, 2.0 and 3.0 inspired vol% (T1, T2 and T3, respectively) during remifentanil-based anesthesia (1.0 mcg/kg/min) for cardiac surgery (n=14):

1. TDI of lateral mitral annulus at systole (S'), early filling (E') and atrial contraction (A')
2. transmitral flow Doppler at early filling (E), atrial contraction (A), deceleration time;
3. LV-ejection fraction (EF)
4. bispectral index (BIS)
5. phenylephrine-infusion rate
6. other pressure derived hemodynamic parameters:heart rate; systolic, diastolic, and mean blood pressures; systolic, diastolic, and mean pulmonary artery pressures; central venous pressure (CVP), pulmonary capillary wedge pressure (PCWP), mixed venous O2 saturation (SvO2), cardiac index (CI) and stroke volume index (SVI)

Conditions

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Valvular Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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sevoflurane

10 min exposure to sevoflurane 1.0, 2.0 and 3.0 inspiratory vol% at sevoflurane dosage titration

Group Type EXPERIMENTAL

Sevoflurane dosage titration

Intervention Type DRUG

comparisons of the effect of the 10 min-inhalation of each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3)

Interventions

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Sevoflurane dosage titration

comparisons of the effect of the 10 min-inhalation of each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3)

Intervention Type DRUG

Other Intervention Names

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sevorane

Eligibility Criteria

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Inclusion Criteria

* patients undergoing cardiac surgery

Exclusion Criteria

* 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 the mediastinum
* upper gastrointestinal bleeding
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae-Yop Kim, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

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Konkuk University Medical Center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Bruch C, Gradaus R, Gunia S, Breithardt G, Wichter T. Doppler tissue analysis of mitral annular velocities: evidence for systolic abnormalities in patients with diastolic heart failure. J Am Soc Echocardiogr. 2003 Oct;16(10):1031-6. doi: 10.1016/S0894-7317(03)00634-5.

Reference Type BACKGROUND
PMID: 14566295 (View on PubMed)

Waggoner AD, Bierig SM. Tissue Doppler imaging: a useful echocardiographic method for the cardiac sonographer to assess systolic and diastolic ventricular function. J Am Soc Echocardiogr. 2001 Dec;14(12):1143-52. doi: 10.1067/mje.2001.115391.

Reference Type BACKGROUND
PMID: 11734780 (View on PubMed)

Other Identifiers

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KUH1160037

Identifier Type: -

Identifier Source: org_study_id

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