Coronary Artery DiseasePhase 2NCT01948765
Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery.
A Phase 2 study testing Xenon and propofol and propofol in people with Coronary Artery Disease and Anesthesia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The investigators hypothesize that the application of 30% xenon as an adjuvant to general anesthesia with a target-controlled infusion of propofol is superior to general anesthesia with propofol alone with respect to hemodynamic stability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Anesthesia
- What is being tested?
- Xenon and propofol and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2013to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with coronary artery disease scheduled for elective OPCAB-surgery
- patients willing and able to complete the requirements of this study
- Ejection fraction >30%
Who cannot join
- Lack of informed consent
- age < 18 years
- COPD GOLD >II
- Renal dysfunction defined as serum-creatinine >1.5mg/dl
- acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support
- single vessel grafting
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- disabling neuropsychiatric disorders (severe dementia, Alzheimer's disease, schizophrenia, depression, low preoperative cognitive state (MMSE at baseline <25), history of stroke with residuals, increased intracranial pressure
- Hypersensitivity to the study medication
- Presumed uncooperativeness or legal incapacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery:a Randomised Controlled Trial
The investigators hypothesize that the application of 30% xenon as an adjuvant to general anesthesia with a target-controlled infusion of propofol is superior to general anesthesia with propofol alone with respect to hemodynamic stability.
- Conditions
- Coronary Artery Disease, Anesthesia
- Being tested
- Xenon and propofol, propofol
- Keywords
- xenon anesthesia, Off-pump coronary artery bypass graft surgery
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenon and propofolDrug
xenon 30% in oxygen as an adjuvant to propofol target controlled infusion (target of 0.5-1.5µg/ml)
propofolDrug
propofol target controlled infusion (target 1.5-2.5µg/ml)
| Study group | Role | What they receive |
|---|---|---|
| Xenon and propofol | Active comparator | Not described Receives: Drug: Xenon and propofol |
| propofol | Placebo comparator | Not described Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative haemodynamic stability
Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption
Measured: intra-operative
Secondary outcomes (8)
MACCE (major adverse cardiac and cerebral events)
Death from any cause, perioperative life-threatening cardiac arrhythmias, perioperative myocardial infarction, requirement of surgical revisions at the coronary vessels, postoperative coronary angioplasty and stroke
Measured: up to six months postoperative
cerebrovascular accident not included in MACCE
cerebrovascular accident not included in MACCE (TIA, reversible ischaemic neurologic deficit)
Measured: up to six months postoperative
postoperative renal function
postoperative renal function as assessed by serum creatinine and BUN levels)
Measured: up to five days postoperative
requirement for blood(product) transfusion
requirement for blood(product) transfusion
Measured: up to five days postoperative
length of stay
requirement for blood(product) transfusion
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days.
severity of postoperative critical illness
Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II), SOFA and APACHE-II score
Measured: up to five days postoperative
incidence and duration of postoperative delirium
incidence and duration of postoperative delirium assessed with the Confusion Assessment Method (CAM-ICU), to be assessed in combination with the Mini Mental State Examination
Measured: participants will be followed for the duration of hospital stay, an expectged average of 10 days
incidence of further AE, SAE and SUSAR
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof Dr Steffen Rex, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948765
- Sponsor's protocol ID
- SR022013
- Status last verified
- Apr 2015
- First submitted
- 8 Aug 2013
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Al Tmimi L, Devroe S, Dewinter G, Van de Velde M, Poortmans G, Meyns B, Meuris B, Coburn M, Rex S. Xenon as an Adjuvant to Propofol Anesthesia in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery: A Pragmatic Randomized Controlled Clinical Trial. Anesth Analg. 2017 Oct;125(4):1118-1128. doi: 10.1213/ANE.0000000000002179.
PubMed 28598913
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery:a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01948765
- Acronym / sponsor ID
- SR022013
- Conditions
- Coronary Artery Disease, Anesthesia
- Keywords
- xenon anesthesia, Off-pump coronary artery bypass graft surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that the application of 30% xenon as an adjuvant to general anesthesia with a target-controlled infusion of propofol is superior to general anesthesia with propofol alone with respect to hemodynamic stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenon and propofol | Active comparator | Drug: Xenon and propofol |
| propofol | Placebo comparator | Drug: propofol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with coronary artery disease scheduled for elective OPCAB-surgery
- patients willing and able to complete the requirements of this study
- Ejection fraction >30%
Key exclusion criteria (9 listed)
- Lack of informed consent
- age < 18 years
- COPD GOLD >II
- Renal dysfunction defined as serum-creatinine >1.5mg/dl
- acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xenon and propofolxenon 30% in oxygen as an adjuvant to propofol target controlled infusion (target of 0.5-1.5µg/ml) | Drug | Xenon and propofol |
| propofolpropofol target controlled infusion (target 1.5-2.5µg/ml) | Drug | propofol |
Primary outcome
intraoperative haemodynamic stability
Time frame: intra-operative
Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption
8 secondary outcomes
MACCE (major adverse cardiac and cerebral events)
Time frame: up to six months postoperative
cerebrovascular accident not included in MACCE
Time frame: up to six months postoperative
postoperative renal function
Time frame: up to five days postoperative
requirement for blood(product) transfusion
Time frame: up to five days postoperative
length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days.
severity of postoperative critical illness
Time frame: up to five days postoperative
incidence and duration of postoperative delirium
Time frame: participants will be followed for the duration of hospital stay, an expectged average of 10 days
incidence of further AE, SAE and SUSAR
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
- Derived from this study: PubMed 28598913Al Tmimi L, Devroe S, Dewinter G, Van de Velde M, Poortmans G, Meyns B, Meuris B, Coburn M, Rex S. Xenon as an Adjuvant to Propofol Anesthesia in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery: A Pragmatic Randomized Controlled Clinical Trial. Anesth Analg. 2017 Oct;125(4):1118-1128. doi: 10.1213/ANE.0000000000002179.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xenon and propofol and propofol in people with Coronary Artery Disease and Anesthesia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative haemodynamic stability (time frame: intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01948765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.