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Coronary Sinus Blood Sevoflurane and Desflurane Concentration and Lactate Changes in Patients Undergoing Heart Surgery (SEVO-DES)

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ClinicalTrials.gov Identifier: NCT02866630
Recruitment Status : Withdrawn (No facility to measure volatile anaesthetic concentration in human blood sample)
First Posted : August 15, 2016
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
University of Edinburgh
Information provided by (Responsible Party):
University of Malaya

Brief Summary:
In the last few years, anaesthetics gas such as isoflurane, desflurane and sevoflurane used in heart surgery have shown some benefits to reduce the risk of heart muscle damage than total intravenous anesthetics. A study by the investigators suggested that isoflurane needs a longer duration to achieve equilibrium between coronary sinus and radial artery, indicating that isoflurane in coronary sinus does not accurately reflect its level in the heart muscle. Different agents have unique characteristics with different equilibration rate. However, the levels of sevoflurane and desflurane in coronary sinus and radial artery have not been measured. In addition, lactate is believed to be a very useful indicator to predict the outcome of recovery phase after any surgery. This study aims to measure the level of sevoflurane or desflurane in blood circulation. It will also assess whether sevoflurane or desflurane concentration in the blood is correlated to the its oxygenator exhaust level and affected by temperature, haematocrit level and gas flow rate during heart-lung machine. It also aims to examine the association of lactate and the outcomes of cardiac patient in intensive care unit after cardiac surgery.

Condition or disease Intervention/treatment
Myocardial Reperfusion Injury Heart Diseases Postoperative Complications Biological: Blood samples

Detailed Description:

In recent years, many clinical trials have demonstrated the myocardial protective properties of volatile anaesthetic agent through a similar mechanism as ischaemic pre-conditioning. It is hypothesised that volatile anaesthetic agent promotes the generation of nitric oxide and reactive oxygen species, which then activates the adenosine receptor, and subsequently initiates the opening of mitochondrial potassium ion channel to minimise perioperative myocardial injury. Many researchers have studied the protective benefit of volatile anaesthesia in heart surgery that involves CPB machine over the last 10 years. In 2006, a meta-analysis of 27 clinical trials have demonstrated that patients receiving volatile anaesthesia either isoflurane, sevoflurane, desflurane or enflurane, experienced lesser myocardial injury, required shorter duration of mechanical ventilation and shorter hospital stay as compared to those tranquilised with a total intravenous anaesthesia technique.

In the administration of volatile anaesthetic agent, the literature review of optimal dosing and timing are not clinically well-established. Unpublished data from the investigators shows that isoflurane requires slightly longer duration to achieve equilibrium between coronary sinus and radial artery, indicating that coronary sinus isoflurane concentration does not accurately reflect its level in myocardium. Also, the temperature of CPB, haematocrit level and gas flow rate appeared to affect the plasma isoflurane concentration to a certain extent. In addition, the investigators only managed to look at isoflurane itself, where other types of volatile anaesthetics namely sevoflurane and desflurane have different nature characteristics and possibly yield to different findings. Furthermore, lactate is believed to be a useful indicator for the outcome of recovery post-operatively. However, it remains unknown that whether would the lactate levels change significantly before, during and after cardiac surgery.

Theoretically, the measurement of volatile anaesthetics concentration in the heart would require a biopsy of heart muscle. Able to identify the level of myocardial anaesthetic level from coronary sinus could be a non-invasive measurement for future studies to look at the optimal concentrations of volatile anaesthetics required to achieve its pharmacological ischaemic pre-conditioning to minimise myocardial damage perioperatively.

The main aim of this study is to determine the level of myocardial sevoflurane or desflurane concentration from coronary sinus blood sample that taken from a coronary sinus catheter, which is routinely inserted to administer retrograde cardioplegia solution instead of invasive biopsy method. This study will also examine the association between the coronary sinus sevoflurane or desflurane concentration and its oxygenator exhaust level during CPB and investigate the influence of temperature, gas flow rate and haematocrit level on plasma sevoflurane or desflurane concentrations. A secondary analysis aims to determine the changes of lactate levels before, during and after cardiac surgery, and the recovery outcomes of cardiac patients in intensive care unit.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Coronary Sinus Blood Sevoflurane and Desflurane Concentration and Lactate Changes in Patients Undergoing Heart Surgery
Estimated Study Start Date : July 20, 2017
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
Cardiopulmonary bypass (Sevoflurane)
All patients who scheduled for an elective heart surgery in University Malaya Medical Centre using a heart-lung machine and the administration of sevoflurane will be recruited in this study. The medical and surgical care plans for participants remain as usual in this study with an exception being six additional blood samples of about two-teaspoonful in volume will be collected from an in-placed catheters in vein and aorta.
Biological: Blood samples
Six additional blood samples will be taken from in-situ catheters during heart surgery

Cardiopulmonary bypass (Desflurane)
All patients who scheduled for an elective heart surgery in University Malaya Medical Centre using a heart-lung machine and the administration of desflurane will be recruited in this study. The medical and surgical care plans for participants remain as usual in this study with an exception being six additional blood samples of about two-teaspoonful in volume will be collected from an in-placed catheters in vein and aorta.
Biological: Blood samples
Six additional blood samples will be taken from in-situ catheters during heart surgery




Primary Outcome Measures :
  1. The Concentration of Anaesthetics in Coronary Sinus and Radial Arterial [ Time Frame: 1 weeks after blood samples taken ]
    All blood samples will be analysed twice for sevoflurane or desflurane with a high performance gas chromatography and mass spectrometry detector (Thermo Scientific TSQ Ultra Triple Quadrupole GC-MS) with a Headspace Autosampler (TriPlus 300). Blood samples were quantified using an external calibration curve prepared in a controlled whole blood over a range of sevoflurane or desflurane concentrations. The reporting measurement unit for sevoflurane or desflurane concentration will be μgmL-1.


Secondary Outcome Measures :
  1. Oxygenator exhaust sevoflurane or desflurane levels on heart-lung machine [ Time Frame: 1 week after measurement of oxygenator exhaust isoflurane gas ]
    The measurement unit for oxygenator exhaust anaesthesia level will be in %, which is analysed by an infrared anaesthetic gas analyser.

  2. Lactate levels before and after surgery [ Time Frame: Lactate measurement at 30 mins before and 1 hour after cardiac surgery ]
    The measurement for lactate level will be in mmolL-1, which is analysed by lactate testing equipment in theatre.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who scheduled for an elective heart surgery in University Malaya Medical Centre involving the administration of sevoflurane or desflurane throughout the operation will be recruited in this study.
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Scheduled for elective cardiac surgery.
  • Anaesthetised using sevoflurane or desflurane throughout the whole operation
  • Patient has consented to participate

Exclusion Criteria:

  • Emergency surgery or patient with malignancy
  • Heart surgery undertaken without CPB
  • Age younger than 18 years
  • Unable or unwilling to provide informed consent
  • Anaesthetised using total intravenous-based technique

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866630


Sponsors and Collaborators
University of Malaya
University of Edinburgh
Investigators
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Principal Investigator: Chew Yin Wang, FRCA (Eng) University Malaya

Publications:
Marco R. Cardiopulmonary bypass. In: Alston, RP, Myles, PS, Ranucci M, editor. Oxford Textbook of Cardiothoracic Anaesthesia. 1st ed. Oxford: Oxford University Press; 2015. p. 117-30.
Pramood, CK, Reena, S, Gajraj S. Ischemic and anesthetic preconditioning of the heart: an insight into the concepts and mechanisms. J Indian Acad Clin Med. 2005;6(1):45-7.
Yoshimi I. Cardiac preconditioning by anesthetic agents: roles of volatile anesthetics and opioids in cardioprotection. Yonago Acta Med. 2007;50:45-55.
Irwin, Michael G, Wong GT. Myocardial Protection During Cardiac Surgery. In: Alston, R Peter, Myles, Paul S, Ranucci M, editor. Oxford Textbook of Cardiothoracic Anaesthesia. 1st ed. Oxford: Oxford University Press; 2015. p. 157-63.
Ng, KT, Alston, P. The Levels of Anaesthetics in Heart Muscle During Heart Surgery (TLAHMHS) [Internet]. ClinicalTrial.gov.my. 2015. Available from: https://clinicaltrials.gov/ct2/show/NCT02471001

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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT02866630     History of Changes
Other Study ID Numbers: UM-1
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Malaya:
Sevoflurane
Desflurane
Coronary Sinus
Oxygenator Exhaust
Lactate
Cardiopulmonary bypass

Additional relevant MeSH terms:
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Heart Diseases
Postoperative Complications
Reperfusion Injury
Myocardial Reperfusion Injury
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Cardiomyopathies
Myocardial Ischemia
Sevoflurane
Desflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs