The Levels of Anaesthetics in Heart Muscle During Heart Surgery

Cardiac Surgery Clinical Trial

— TLAHMHS  

Official title:

Coronary Sinus Blood Isoflurane Concentration in Patients Undergoing Heart Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471001
• Other study ID #: UEdin-15
• Status: Completed
• Phase: N/A
• First received: June 4, 2015
• Last updated: November 23, 2016
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Department of Anaesthesia and Critical Care	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

BIGELOW WG, LINDSAY WK, GREENWOOD WF. Hypothermia; its possible role in cardiac surgery: an investigation of factors governing survival in dogs at low body temperatures. Ann Surg. 1950 Nov;132(5):849-66. — View Citation

Chiu-Fen Y, Michael Yu-Chih C, Tsung-I C, Ching-Feng Cheng. Dose-dependent effects of isoflurane on cardiovascular function in rats. Tzu Chi Medical Journal 2014; 26 (3): 119-22

Fabien Picard, Francis Depret, Sergio ZC, Steven Hollenberg. Effect of anesthesia level on murine cardiac function. F1000 Research 2014; 3: 165-72

Hausenloy DJ, Boston-Griffiths E, Yellon DM. Cardioprotection during cardiac surgery. Cardiovasc Res. 2012 May 1;94(2):253-65. doi: 10.1093/cvr/cvs131. Review. — View Citation

Pramood CK, Reena S, Gajraj SS. Ischemic and anesthetic preconditioning of the heart: an insight into the concepts and mechanisms. Journal Indian Academy of Clinical Medicine; 2005; 6(1): 45-7

R. Peter Alston, Paul Myles, Marco Ranucci. Oxford Textbook of Cardiothoracic Anaesthesia. Oxford University Press 2015. Chapter 15 Myocardial protection during cardiac surgery. 157-65.

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. Review. — View Citation

Yau JM, Alexander JH, Hafley G, Mahaffey KW, Mack MJ, Kouchoukos N, Goyal A, Peterson ED, Gibson CM, Califf RM, Harrington RA, Ferguson TB; PREVENT IV Investigators.. Impact of perioperative myocardial infarction on angiographic and clinical outcomes following coronary artery bypass grafting (from PRoject of Ex-vivo Vein graft ENgineering via Transfection [PREVENT] IV). Am J Cardiol. 2008 Sep 1;102(5):546-51. doi: 10.1016/j.amjcard.2008.04.069. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of Isoflurane in coronary sinus blood		1 week after blood samples taken	Yes
Secondary	Isoflurane level in oxygenator exhaust levels on heart-lung machine		Immediately after the heart surgery is over	Yes