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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Konkuk University Medical Center
Sponsor:
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, Konkuk University Medical Center
ClinicalTrials.gov Identifier:
NCT01511991
First received: January 11, 2012
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Valvular Heart Disease
Drug: Sevoflurane dosage titration
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Sevoflurane's Effect on Tissue Doppler Profiles of Lateral Mitral Annulus During Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Konkuk University Medical Center:

Primary Outcome Measures:
  • Peak mitral annular velocity during systole (S') [ Time Frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol% ] [ Designated as safety issue: No ]
    By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)

  • Peak mitral annular velocity during early filling (E') [ Time Frame: after 10 min exposure to sevoflurane of 1.0 vol%, 2.0 vol% and 3.0 vol% ] [ Designated as safety issue: No ]
    By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, E' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)

  • peak mitral annular velocity during atrial contraction(A') [ Time Frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol% ] [ Designated as safety issue: No ]
    By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, A' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)


Secondary Outcome Measures:
  • ejection fraction (EF) [ Time Frame: after 10 min exposure to sevoflrane 1.0vol%, 2.0 vol% and 3.0 vol% ] [ Designated as safety issue: No ]
    By using modified Simpson technique in the midesophageal 4-chamber view, EF would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)

  • bispectral index (BIS) [ Time Frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol% ] [ Designated as safety issue: No ]
    BIS would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)

  • peak velocity of mitral inflow during early relaxation (E) [ Time Frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol% ] [ Designated as safety issue: No ]
    By using pulsed Doppler with the sample volume positioned at the lMV opening in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)

  • peak velocity of mitral inflow during atrial contraction (A) [ Time Frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol% ] [ Designated as safety issue: No ]
    By using pulsed Doppler with the sample volume positioned at the tip of MV oeneing in the midesophageal 4-chamber view, "A" would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)


Estimated Enrollment: 20
Study Start Date: May 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sevoflurane
10 min exposure to sevoflurane 1.0, 2.0 and 3.0 inspiratory vol% at sevoflurane dosage titration
Drug: 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)
Other Name: sevorane

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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511991

Contacts
Contact: Tae-Yop Kim, MD PhD 82-2-2030-5445 taeyop@gmail.com

Locations
Korea, Republic of
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 143-729
Principal Investigator: Tae-Yop Kim, MD PhD         
Sponsors and Collaborators
Konkuk University Medical Center
Investigators
Principal Investigator: Tae-Yop Kim, MD PhD Konkuk University Medical Center
  More Information

Publications:
Responsible Party: Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT01511991     History of Changes
Other Study ID Numbers: KUH1160037
Study First Received: January 11, 2012
Last Updated: May 16, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Konkuk University Medical Center:
cardiac surgery
sevoflurane
tissue Doppler

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Sevoflurane
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014