- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02471950
Isoflurane During Cardiopulmonary Bypass
The Depth of Anaesthesia Associated With the Use of 2.5% Isoflurane During Cardiopulmonary Bypass
Study Overview
Status
Intervention / Treatment
Detailed Description
There is no clinical way of assessing patients' depth of anaesthesia on the heart-lung machine. For this reason, the amount of volatile anaesthetic agent like isoflurane, that is administered has traditionally been determined by anaesthetists' clinical experience. Recently, a device that assesses depth of anaesthesia by analysing the electrical brain waves called the Bispectral index (BIS) has been introduced. The study aims to determine whether the level of anaesthesia produced by isoflurane using the traditional approach is more than required simply to maintain unconsciousness according to BIS. In addition, the study will determine whether the concentration of isoflurane in exhaust gases from the heart-lung machine can be used as an estimate arterial blood concentration and so, depth of anaesthesia.
The study will recruit patients who are scheduled for heart surgery using a heart-lung machine. Patients will be anaesthetised using a long established balanced technique including the administration of isoflurane 2.5% whilst supported on the heart-lung machine. Measurements of exhaust gas concentration of isoflurane from the heart-lung machine and level of BIS will be recorded at three time points. Simultaneously, three arterial blood samples will be taken and the isoflurane concentration measured in these samples. The BIS levels will be averaged and the proportion of patients with a BIS below 40 (lower limit of normal) will be calculated. Concentrations of isoflurane in the exhaust gas of the heart-lung machine will be compared with blood concentrations of isoflurane and the both concentrations will be compared with the level of BIS to establish whether they can be used to assess depth of anaesthesia.
If this study finds that a large proportion of patients have more than adequate levels of anaesthesia, then future studies could explore whether administering lower concentrations of isoflurane improves outcome whilst maintaining anaesthesia.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Scotland
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Edinburgh, Scotland, United Kingdom, EH16 4SA
- Royal Infirmary of Edinburgh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants over the age of 18
- Scheduled for elective cardiac surgery under the care of trial anaesthetists
- Patient has provided informed consent to participate
Exclusion Criteria:
- Patients presenting for emergency cardiac surgery
- Patients who will have cardiac surgery that does not require cardiopulmonary bypass
- Unwilling/unable to provide informed consent
- Patients under the age of 18
- Anaesthesia undertaken by anaesthetists not involved in trial
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Elective Cardiac surgery
Those patients scheduled for elective heart surgery requiring cardiopulmonary bypass who will be given 2.5% isoflurane while on bypass.
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Anaesthesia maintained during cardiopulmonary bypass with 2.5% isoflurane administered via the oxygenator of the bypass circuit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depth of anesthesia according to BIS
Time Frame: Intraoperative
|
BIS reading will be recorded at three time points during cardiopulmonary bypass
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Intraoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of exhaust gas and blood concentration of isoflurane
Time Frame: Intraoperative
|
Exhaust gas and blood concentrations of isoflurane will be recorded at three time points during the operation.
These values will be compared to see if their values are are related.
|
Intraoperative
|
Comparison of blood isoflurane concentration and BIS score
Time Frame: Intraoperative
|
Blood isoflurane concentration and BIS will be recorded at three time points and compared to see if they are related
|
Intraoperative
|
Comparison of exhaust isoflurane Concentration and BIS score
Time Frame: Intraoperative
|
Exhaust isoflurane and BIS will be recorded at three time points and compared to see they are related.
|
Intraoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Alston, MBChB, University of Edinburgh
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15 LO 0366
- 2015/0199 (Other Identifier: NHS Lothian)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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