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The Levels of Anaesthetics in Heart Muscle During Heart Surgery

Coronary Sinus Blood Isoflurane Concentration in Patients Undergoing Heart Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02471001
Acronym
TLAHMHS
Enrollment
23
Registered
2015-06-12
Start date
2015-09-30
Completion date
2016-06-30
Last updated
2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

concentration, Isoflurane, cardioprotective, cardioplegia, heart surgery, Disorder, Heart, Functional, Postoperative

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALBlood samples

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

Sponsors

NHS Lothian
CollaboratorOTHER_GOV
University of Edinburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Levels of Isoflurane in coronary sinus blood1 week after blood samples taken

Secondary

MeasureTime frame
Isoflurane level in oxygenator exhaust levels on heart-lung machineImmediately after the heart surgery is over

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026