Coronary Sinus Blood Sevoflurane and Desflurane Concentration and Lactate Changes in Patients Undergoing Heart Surgery

NCT02866630 | Withdrawn

• 1 other identifier: UM-1
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myocardial Reperfusion Injury; Heart Diseases; Postoperative Complications

Keywords

Sevoflurane; Desflurane; Coronary Sinus; Oxygenator Exhaust; Lactate; Cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• The Concentration of Anaesthetics in Coronary Sinus and Radial Arterial

  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.

  1 weeks after blood samples taken

Secondary Outcomes (2)

• Oxygenator exhaust sevoflurane or desflurane levels on heart-lung machine

  1 week after measurement of oxygenator exhaust isoflurane gas

• Lactate levels before and after surgery

  Lactate measurement at 30 mins before and 1 hour after cardiac surgery

Study Arms (2)

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

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

Interventions

Blood samples BIOLOGICAL

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

Cardiopulmonary bypass (Desflurane); Cardiopulmonary bypass (Sevoflurane)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead
• University of Edinburgh: collaborator

Related Publications (8)

• Belhomme D, Peynet J, Louzy M, Launay JM, Kitakaze M, Menasche P. Evidence for preconditioning by isoflurane in coronary artery bypass graft surgery. Circulation. 1999 Nov 9;100(19 Suppl):II340-4. doi: 10.1161/01.cir.100.suppl_2.ii-340.

  PMID: 10567326 BACKGROUND

• Landoni G, Greco T, Biondi-Zoccai G, Nigro Neto C, Febres D, Pintaudi M, Pasin L, Cabrini L, Finco G, Zangrillo A. Anaesthetic drugs and survival: a Bayesian network meta-analysis of randomized trials in cardiac surgery. Br J Anaesth. 2013 Dec;111(6):886-96. doi: 10.1093/bja/aet231. Epub 2013 Jul 12.

  PMID: 23852263 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Yoshimi I. Cardiac preconditioning by anesthetic agents: roles of volatile anesthetics and opioids in cardioprotection. Yonago Acta Med. 2007;50:45-55.

  BACKGROUND

• 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.

  BACKGROUND

• Symons JA, Myles PS. Myocardial protection with volatile anaesthetic agents during coronary artery bypass surgery: a meta-analysis. Br J Anaesth. 2006 Aug;97(2):127-36. doi: 10.1093/bja/ael149. Epub 2006 Jun 21.

  PMID: 16793778 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Myocardial Reperfusion Injury; Heart Diseases; Postoperative Complications

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cardiomyopathies; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Reperfusion Injury; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Chew Yin Wang, FRCA (Eng)

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: August 15, 2016
• Study Start: July 20, 2017
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share