Clinical trial NCT01511991: Sevoflurane's Effect on Mitral Valve Annular Velocity in Cardiac Surgery
Official title: Sevoflurane's Effect on Tissue Doppler Profiles of Lateral Mitral Annulus During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Valvular Heart Disease
Keywords: cardiac surgery
sevoflurane
tissue Doppler
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Peak mitral annular velocity during systole (S')
timeFrame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
measure: Peak mitral annular velocity during early filling (E')
timeFrame: after 10 min exposure to sevoflurane of 1.0 vol%, 2.0 vol% and 3.0 vol%
measure: peak mitral annular velocity during atrial contraction(A')
timeFrame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
Secondary outcomes:
measure: ejection fraction (EF)
timeFrame: after 10 min exposure to sevoflrane 1.0vol%, 2.0 vol% and 3.0 vol%
measure: bispectral index (BIS)
timeFrame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
measure: peak velocity of mitral inflow during early relaxation (E)
timeFrame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
measure: peak velocity of mitral inflow during atrial contraction (A)
timeFrame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Tae-Yop Kim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.