The Levels of Anaesthetics in Heart Muscle During Heart Surgery

NCT ID: NCT02471001

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Cardiac Surgery

Keywords

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concentration Isoflurane cardioprotective cardioplegia heart surgery Disorder Heart Functional Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Heart Surgery Using Heart-lung Machine

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. The medical and surgical care plans for participants remain as usual in this study with an exception being two additional blood samples of about two-teaspoonful in volume will be collected from an in-placed catheters in vein and aorta.

Blood samples

Intervention Type BIOLOGICAL

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

Interventions

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Blood samples

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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R Peter Alston, MB ChB

Role: PRINCIPAL_INVESTIGATOR

NHS Lothian

Locations

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Department of Anaesthesia and Critical Care

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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. Epub 2008 Jul 2.

Reference Type BACKGROUND
PMID: 18721510 (View on PubMed)

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. doi: 10.1097/00000658-195011000-00001. No abstract available.

Reference Type BACKGROUND
PMID: 14771796 (View on PubMed)

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

Reference Type BACKGROUND

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. Epub 2012 Mar 22.

Reference Type BACKGROUND
PMID: 22440888 (View on PubMed)

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.

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 16793778 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

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UEdin-15

Identifier Type: -

Identifier Source: org_study_id