Sevoflurane Effect on Left Atrial Performance: A Transoesophageal Echocardiographic Study

December 31, 2019 updated by: Dr.Ibrahim Mamdouh Esmat, Ain Shams University

Sevoflurane Effect on Left Atrial Performance: A Transoesophageal Echocardiographic Study on Patients Undergoing Coronary Artery Bypasses Grafting

The left atrial performance is affected by the preload as well as the afterload. The LA active pumping is increased by stretching of the LA but within limits, after which the active pumping declines. The LV stiffness acts as the LA afterload. Whenever the LV stiffness increases, the overall emptying fraction becomes more pumpdependent

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The echocardiographic assessment of the LA was frequently overlooked. While left atrial performance reflects both systolic and diastolic functions of the LV, it looks like more studies are being conducted to detect the effect of different interventions on the left atrial size and function. Other studies focus on the prognostic value and the ability to risk stratify different cohorts of patients, based on the early recognition of deranged LA performance.

Many studies were conducted on the effect of inhalational anesthetics on the left atrial function. Yet the results are inconclusive and sometimes contradictory. In a study on dogs, Gare Meir and his colleagues proved that desflurane, sevoflurane, and isoflurane depress left atrial contractility, delay relaxation, reduce chamber stiffness, preserve reservoir and conduit function, and impair left atrial-left ventricular coupling in vivo. Volatile anesthetics may cause impairment of both left atrial (LA) and left ventricular (LV) contractility. The mechanisms suggested were a decrease in the influx of calcium via voltage gated calcium channels as well as a decrease in calcium availability from sarcoplasmic reticulum.Echocardiographic assessment of the LA volumetric measures is comparable to that of Cardiovascular Magnetic Resonance (CMR) with clinically irrelevant difference. This makes echocardiographic assessment of LA volumes reliable, cheaperand easier to obtain.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11361
        • Ain-Shams University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult patients of any sex,40-75 years, maintaining sinus rhythm undergoing elective with preserved left ventricular systolic function.

Description

Inclusion Criteria:

  • Clinical diagnosis of ischemic heart disease
  • Elective coronary artery bypass grafting.

Exclusion Criteria:

  • Atrial or ventricular dysrhythmias,
  • Associated mitral valve disease,
  • Ejection Fraction <40%,
  • Emergency coronary artery bypass grafting,
  • Pericardial disease
  • Contraindication to perform a TEE, e.g. Esophageal tumor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
intraoperative transoesophageal echocardiography to test the effect of Sevoflurane on left atrial performance
Time Frame: 30 Minutes (Start point: After induction of anesthesia and before starting sevoflurane (first set of data). End point: After achieving one MAC sevoflurane anesthesia and before skin incision (second set of data)).
Mitral inflow early diastolic velocity (meter/second)(m/s)
30 Minutes (Start point: After induction of anesthesia and before starting sevoflurane (first set of data). End point: After achieving one MAC sevoflurane anesthesia and before skin incision (second set of data)).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R 35 / 2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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