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Completed

NCT Number: NCT02471001

The Levels of Anaesthetics in Heart Muscle During Heart Surgery

In the last few years, anaesthetic agents, Isoflurane used in heart surgery have shown some benefits to reduce the risk of heart muscle damage. Many research studies have been conducted to reveal the benefit relationship between Isoflurane and the risk of heart muscle injury during heart surgery. However, there is a knowledge gap regarding the optimal level of Isoflurane concentration to confer the benefit of heart muscle-protective properties. Therefore, this study is conducted to answer that question by measuring the Isoflurane concentration in the blood vessels. It also assesses whether Isoflurane concentration in the blood is correlated to the oxygenator exhaust level of Isoflurane in the heart-lung machine.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesia and Critical Care

Edinburgh, United Kingdom

About this study

All patients who scheduled for an elective heart surgery in Royal Infirmary of Edinburgh using a heart-lung machine and the administration of ether-like anaesthetic, isoflurane will be recruited in this study. This is a pilot study to determine the concentration of isoflurane in heart muscle. Isaac and Michael (2005), Hill (1998), Julious (2005) have conducted survey/research to conclude that 30 sample sizes are adequate for a pilot study. Thus, investigators aim to recruit at least 30 sample sizes to allow data (standard deviation, mean etc.) used in sample size estimation for future studies.

The medical and surgical care plans for participants remain as usual in this study. In a normal practise, surgeons will insert a catheter into the blood vessels coming from the heart to deliver solution to stop the contraction of heart for heart procedure. At this moment, two blood samples of about two-teaspoonful in volume will be collected from the in-placed catheters in vein and aorta. Then, the blood samples will be sent to lab to measure the concentration of isoflurane in vein and aorta. Also, the reading of exhausted isoflurane gas on heart-lung machine are routinely monitored and recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Scheduled for elective cardiac surgery requiring cardiopulmonary bypass.
  • Anaesthetised using isoflurane as part of a balanced anaesthetic technique during heart-lung machine
  • Patient has consented to participate
  • Cardioplegia technique involves insertion of a coronary sinus catheter.

Exclusion criteria

  • Emergency surgery or patient with malignancy
  • Heart surgery undertaken without heart-lung machine
  • Age younger than 18 years
  • Unable or unwilling to provide informed consent
  • Cardiac surgery that does not require cardiopulmonary bypass
  • Anaesthetised using an total intravenous-based technique

Treatment and study plan

blood samples

Biological

Two additional blood samples will be taken from in-situ catheters during heart surgery.

Primary outcomes

  1. Levels of Isoflurane in coronary sinus blood

    Time frame: 1 week after blood samples taken

Secondary outcomes

  1. Isoflurane level in oxygenator exhaust levels on heart-lung machine

    Time frame: Immediately after the heart surgery is over

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

Coronary Sinus Blood Isoflurane Concentration in Patients Undergoing Heart Surgery

Acronym: TLAHMHS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 12, 2015
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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