Ischemia Reperfusion InjuryNCT03510793
Microcirculation and Anesthesia in Vascular Surgery
An observational study of Ischemia Reperfusion Injury and Aortic Aneurysm, run by Università Politecnica delle Marche.
Trial summary
Ischemia/reperfusion injury following aortic cross-clamping for vascular surgery leads to systemic hemodynamic and microcirculatory perturbances. The use of different anesthetic regimens may have an impact on tissue perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia Reperfusion Injury, Aortic Aneurysm, Anesthesia
- What is being tested?
- balanced anesthesia and Total intravenous anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 30 Nov 2017
- Phase
- Observational
- 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
Study population: adult (>18 years old) patients scheduled for elective open aortic aneurysm repair under general anesthesia, who will receive balanced or total intravenous anesthesia according to the attending physician's decision
Who may be able to join
- elective infrarenal abdominal aortic open repair
- protocol of intraoperative goal-directed therapy
- ASA class I-II-III
Who cannot join
- age of less than 18 years
- pregnancy
- Endovascular Aneurysm Repair (EVAR)
- concomitant infections
- trauma
- emergency surgery
About this study
Official title: Changes in the Sublingual Microcirculation Following Aortic Surgery Under Balanced or Total Intravenous Anesthesia: a Prospective Observational Study
Ischemia/reperfusion injury following aortic cross-clamping for vascular surgery leads to systemic hemodynamic and microcirculatory perturbances. The use of different anesthetic regimens may have an impact on tissue perfusion. The aim of this study was to explore changes in microvascular perfusion in patients undergoing elective open abdominal aortic aneurysm repair under balanced or total intravenous anesthesia. Prospective observational study on 40 patients scheduled for elective open infrarenal abdominal aortic aneurysm repair, who received balanced (desflurane + remifentanil, n=20) or total intravenous anesthesia (TIVA, propofol + remifentanil using target-controlled infusion, n=20) according to the clinician's decision. A goal-directed hemodynamic management was applied in all patients. Hemodynamics and arterial/venous blood gases were compared before anesthesia induction (baseline) and at end-surgery. Changes in sublingual microvascular flow and density were assessed with incident dark field illumination imaging. Near infrared spectroscopy was applied on the thenar eminence with a vascular occlusion test (VOT) to assess variations in the peripheral muscle tissue oxygenation and microcirculatory reactivity.
Read the detailed description
Ischemia/reperfusion (I/R) injury is a common problem in patients undergoing aortic clamping for vascular surgery and may lead to systemic inflammation and organ dysfunction. Increased production of pro-inflammatory molecules and oxidative stress induced by I/R are responsible for microvascular alterations similar to those observed during sepsis, which result in tissue hypoxia. Anesthetics can affect the microcirculation. Propofol causes vasodilation stimulating NO production and decreases microvascular density. A final arteriolar vasodilation could involve a greater oxygen delivery and better perfusion, but a massive dose-dependent vasodilation could lead to a shunt of blood flow with reduced oxygen availability. Volatile anesthetics cause dose-dependent vasodilation too and desflurane, unlike isoflurane and alothane, maintains myocardial, hepatic, intestinal and muscle blood flow. This prospective observational study aims to evaluate the effects of intravenous and balanced anesthesia on sublingual and peripheral muscle microcirculation in patients undergoing elective open abdominal aortic aneurysm repair. This study was approved by the investigator's local ethical committee of Azienda Ospedaliera Universitaria "Ospedali Riuniti" of Ancona, Italy. A written informed consent was obtained from all patients. Patients were eligible if they were scheduled for elective infrarenal abdominal aortic open repair with or without prosthetic aorto-aortic or aorto-bisiliac bypass under general anesthesia. Patients received balanced (desflurane + remifentanil) or total intravenous (TIVA, propofol + remifentanil, with target-controlled infusion) anesthesia according to the attending physician's decision, resulting in two study groups. Spectral entropy was used in monitoring anesthetic depth. A goal-directed hemodynamic management was applied in all patients. Hemodynamics was evaluated with Flotrac/Vigileo (Edwards Lifesciences) monitor according to routine clinical practice. Arterial and central venous blood gases were measured according to routine clinical practice. All measurements were collected before anesthesia induction (baseline) and at end-surgery. Changes in sublingual microvascular flow and density were assessed with incident dark field illumination imaging (Cytocam, Braedius, Amsterdam, NL). After gentle removal of saliva and other secretions with a gauze, the probe was applied to the sublingual region, avoiding excessive pressure. Three sequences of 10 seconds each were recorded in 3 different mucosal areas. Subsequently, clips were analysed offline by AVA software (Automated Vascular Analysis v3.0). The following parameters were calculated for small vessels: microvascular flow index, total vessel density, perfused vessel density, percentage of perfused vessels, flow heterogeneity index. Near infrared spectroscopy (InSpectra, Hutchinson Technology, MN, USA) was applied on the thenar eminence with a vascular occlusion test (VOT) to assess variations in the peripheral muscle tissue oxygenation and microcirculatory reactivity. A probe was applied on the thenar eminence, and, after a 3-minute period of stabilization, tissue O2 saturation (StO2) and tissue haemoglobin index (THI) were recorded. Then arterial inflow was arrested by inflating a sphygmomanometer cuff to 50mmHg above the systolic arterial pressure; the cuff was kept inflated until StO2 decreased to 40% and finally was released. StO2 modifications were continuously recorded during the reperfusion phase until stabilization. The following parameters were extrapolated: StO2 downslope, StO2 upslope, area of hyperemia. Statistics: normality of distribution will be assessed with Kolmogorov-Smirnov test. Data will be expressed as mean±standard deviation or median [1st-3rd quartile], as appropriate. Two-way ANOVA with Sidack's multiple comparisons test or Wilcoxon and Mann-Whitney U test were used to compare variables between the two time points into the same group and between two groups at time-matched points as appropriate. A p value <0.05 was used to indicate statistical significance.
- Conditions
- Ischemia Reperfusion Injury, Aortic Aneurysm, Anesthesia
- Being tested
- balanced anesthesia, Total intravenous anesthesia
- Keywords
- microcirculation; aortic aneurysm; anesthesia
- Medical subject headings
- Reperfusion Injury, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balanced anesthesiaDrug
patients undergoing open elective abdominal aortic aneurysm repair will receive balanced (desflurane + remifentanil) anaesthesia
Total intravenous anesthesiaDrug
patients undergoing open elective abdominal aortic aneurysm repair will receive total intravenous (propofol + remifentanil with target-controlled infusion) anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Balanced anesthesia | Patients receiving balanced anesthesia (desflurane + remifentanil) according to the attending physician's decision Receives: Drug: balanced anesthesia | |
| Total intravenous anesthesia | Patients receiving total intravenous anesthesia (TIVA) using propofol + remifentanil with target-controlled infusion according to the attending physician's decision. Receives: Drug: Total intravenous anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the microvascular flow index
Variation in the microvascular flow index, which is a parameter of capillary blood flow quality, calculated for small (diameter <20 microns) vessels in the sublingual microcirculation
Measured: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
Secondary outcomes (3)
change in microvascular density
Variation in parameters of sublingual total and perfused vessel densities
Measured: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
change in tissue oxygenation
Variation in skeletal muscle (thenar eminence) StO2
Measured: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
change in microvascular reactivity
Variation in skeletal muscle (thenar eminence) StO2 upslope, which is the slope of the reperfusion phase during the vascular occlusion test
Measured: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Sep 2013
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemia Reperfusion InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abele Donati, MD, Università Politecnica delle Marche
- Investigators
- Abele Donati, Principal investigator, Università Politecnica delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510793
- Sponsor's protocol ID
- Vasc2018
- Status last verified
- Apr 2018
- First submitted
- 24 Apr 2018
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Petros AJ, Bogle RG, Pearson JD. Propofol stimulates nitric oxide release from cultured porcine aortic endothelial cells. Br J Pharmacol. 1993 May;109(1):6-7. doi: 10.1111/j.1476-5381.1993.tb13523.x.
PubMed 8388302Koch M, De Backer D, Vincent JL, Barvais L, Hennart D, Schmartz D. Effects of propofol on human microcirculation. Br J Anaesth. 2008 Oct;101(4):473-8. doi: 10.1093/bja/aen210. Epub 2008 Jul 23.
PubMed 18653494O'Riordan J, O'Beirne HA, Young Y, Bellamy MC. Effects of desflurane and isoflurane on splanchnic microcirculation during major surgery. Br J Anaesth. 1997 Jan;78(1):95-6. doi: 10.1093/bja/78.1.95.
PubMed 9059215Loggi S, Mininno N, Damiani E, Marini B, Adrario E, Scorcella C, Domizi R, Carsetti A, Pantanetti S, Pagliariccio G, Carbonari L, Donati A. Changes in the sublingual microcirculation following aortic surgery under balanced or total intravenous anaesthesia: a prospective observational study. BMC Anesthesiol. 2019 Jan 5;19(1):1. doi: 10.1186/s12871-018-0673-7.
PubMed 30611197
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Sublingual Microcirculation Following Aortic Surgery Under Balanced or Total Intravenous Anesthesia: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03510793
- Acronym / sponsor ID
- Vasc2018
- Conditions
- Ischemia Reperfusion Injury, Aortic Aneurysm, Anesthesia
- Keywords
- microcirculation; aortic aneurysm; anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 27 Apr 2018 (actual)
- 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.
Ischemia/reperfusion injury following aortic cross-clamping for vascular surgery leads to systemic hemodynamic and microcirculatory perturbances. The use of different anesthetic regimens may have an impact on tissue perfusion. The aim of this study was to explore changes in microvascular perfusion in patients undergoing elective open abdominal aortic aneurysm repair under balanced or total intravenous anesthesia. Prospective observational study on 40 patients scheduled for elective open infrarenal abdominal aortic aneurysm repair, who received balanced (desflurane + remifentanil, n=20) or total intravenous anesthesia (TIVA, propofol + remifentanil using target-controlled infusion, n=20) according to the clinician's decision. A goal-directed hemodynamic management was applied in all patients. Hemodynamics and arterial/venous blood gases were compared before anesthesia induction (baseline) and at end-surgery. Changes in sublingual microvascular flow and density were assessed with incident dark field illumination imaging. Near infrared spectroscopy was applied on the thenar eminence with a vascular occlusion test (VOT) to assess variations in the peripheral muscle tissue oxygenation and microcirculatory reactivity.
Detailed description
Ischemia/reperfusion (I/R) injury is a common problem in patients undergoing aortic clamping for vascular surgery and may lead to systemic inflammation and organ dysfunction. Increased production of pro-inflammatory molecules and oxidative stress induced by I/R are responsible for microvascular alterations similar to those observed during sepsis, which result in tissue hypoxia. Anesthetics can affect the microcirculation. Propofol causes vasodilation stimulating NO production and decreases microvascular density. A final arteriolar vasodilation could involve a greater oxygen delivery and better perfusion, but a massive dose-dependent vasodilation could lead to a shunt of blood flow with reduced oxygen availability. Volatile anesthetics cause dose-dependent vasodilation too and desflurane, unlike isoflurane and alothane, maintains myocardial, hepatic, intestinal and muscle blood flow. This prospective observational study aims to evaluate the effects of intravenous and balanced anesthesia on sublingual and peripheral muscle microcirculation in patients undergoing elective open abdominal aortic aneurysm repair. This study was approved by the investigator's local ethical committee of Azienda Ospedaliera Universitaria "Ospedali Riuniti" of Ancona, Italy. A written informed consent was obtained from all patients. Patients were eligible if they were scheduled for elective infrarenal abdominal aortic open repair with or without prosthetic aorto-aortic or aorto-bisiliac bypass under general anesthesia. Patients received balanced (desflurane + remifentanil) or total intravenous (TIVA, propofol + remifentanil, with target-controlled infusion) anesthesia according to the attending physician's decision, resulting in two study groups. Spectral entropy was used in monitoring anesthetic depth. A goal-directed hemodynamic management was applied in all patients. Hemodynamics was evaluated with Flotrac/Vigileo (Edwards Lifesciences) monitor according to routine clinical practice. Arterial and central venous blood gases were measured according to routine clinical practice. All measurements were collected before anesthesia induction (baseline) and at end-surgery. Changes in sublingual microvascular flow and density were assessed with incident dark field illumination imaging (Cytocam, Braedius, Amsterdam, NL). After gentle removal of saliva and other secretions with a gauze, the probe was applied to the sublingual region, avoiding excessive pressure. Three sequences of 10 seconds each were recorded in 3 different mucosal areas. Subsequently, clips were analysed offline by AVA software (Automated Vascular Analysis v3.0). The following parameters were calculated for small vessels: microvascular flow index, total vessel density, perfused vessel density, percentage of perfused vessels, flow heterogeneity index. Near infrared spectroscopy (InSpectra, Hutchinson Technology, MN, USA) was applied on the thenar eminence with a vascular occlusion test (VOT) to assess variations in the peripheral muscle tissue oxygenation and microcirculatory reactivity. A probe was applied on the thenar eminence, and, after a 3-minute period of stabilization, tissue O2 saturation (StO2) and tissue haemoglobin index (THI) were recorded. Then arterial inflow was arrested by inflating a sphygmomanometer cuff to 50mmHg above the systolic arterial pressure; the cuff was kept inflated until StO2 decreased to 40% and finally was released. StO2 modifications were continuously recorded during the reperfusion phase until stabilization. The following parameters were extrapolated: StO2 downslope, StO2 upslope, area of hyperemia. Statistics: normality of distribution will be assessed with Kolmogorov-Smirnov test. Data will be expressed as mean±standard deviation or median [1st-3rd quartile], as appropriate. Two-way ANOVA with Sidack's multiple comparisons test or Wilcoxon and Mann-Whitney U test were used to compare variables between the two time points into the same group and between two groups at time-matched points as appropriate. A p value <0.05 was used to indicate statistical significance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balanced anesthesia | – | Drug: balanced anesthesiaPatients receiving balanced anesthesia (desflurane + remifentanil) according to the attending physician's decision |
| Total intravenous anesthesia | – | Drug: Total intravenous anesthesiaPatients receiving total intravenous anesthesia (TIVA) using propofol + remifentanil with target-controlled infusion according to the attending physician's decision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult (>18 years old) patients scheduled for elective open aortic aneurysm repair under general anesthesia, who will receive balanced or total intravenous anesthesia according to the attending physician's decision
Key inclusion criteria (3 listed)
- elective infrarenal abdominal aortic open repair
- protocol of intraoperative goal-directed therapy
- ASA class I-II-III
Key exclusion criteria (6 listed)
- age of less than 18 years
- pregnancy
- Endovascular Aneurysm Repair (EVAR)
- concomitant infections
- trauma
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 |
|---|---|---|
| balanced anesthesiapatients undergoing open elective abdominal aortic aneurysm repair will receive balanced (desflurane + remifentanil) anaesthesia | Drug | Balanced anesthesia |
| Total intravenous anesthesiapatients undergoing open elective abdominal aortic aneurysm repair will receive total intravenous (propofol + remifentanil with target-controlled infusion) anesthesia | Drug | Total intravenous anesthesia |
Primary outcome
change in the microvascular flow index
Time frame: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
Variation in the microvascular flow index, which is a parameter of capillary blood flow quality, calculated for small (diameter <20 microns) vessels in the sublingual microcirculation
3 secondary outcomes
change in microvascular density
Time frame: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
change in tissue oxygenation
Time frame: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
change in microvascular reactivity
Time frame: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
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 3 May 2018.
- Results publication: PubMed 8388302Petros AJ, Bogle RG, Pearson JD. Propofol stimulates nitric oxide release from cultured porcine aortic endothelial cells. Br J Pharmacol. 1993 May;109(1):6-7. doi: 10.1111/j.1476-5381.1993.tb13523.x.
- Results publication: PubMed 18653494Koch M, De Backer D, Vincent JL, Barvais L, Hennart D, Schmartz D. Effects of propofol on human microcirculation. Br J Anaesth. 2008 Oct;101(4):473-8. doi: 10.1093/bja/aen210. Epub 2008 Jul 23.
- Results publication: PubMed 9059215O'Riordan J, O'Beirne HA, Young Y, Bellamy MC. Effects of desflurane and isoflurane on splanchnic microcirculation during major surgery. Br J Anaesth. 1997 Jan;78(1):95-6. doi: 10.1093/bja/78.1.95.
- Derived from this study: PubMed 30611197Loggi S, Mininno N, Damiani E, Marini B, Adrario E, Scorcella C, Domizi R, Carsetti A, Pantanetti S, Pagliariccio G, Carbonari L, Donati A. Changes in the sublingual microcirculation following aortic surgery under balanced or total intravenous anaesthesia: a prospective observational study. BMC Anesthesiol. 2019 Jan 5;19(1):1. doi: 10.1186/s12871-018-0673-7.
- Individual participant dataSharing planned: No
Related trials for Ischemia Reperfusion Injury
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingPhase 2
Perioperative Ursodeoxycholic Acid for Renal Protection in Adults Undergoing Partial Nephrectomy for Renal Tumors
Kidney Cancer
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.
Abele Donati principal investigator
Università Politecnica delle Marche
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemia Reperfusion Injury and Aortic Aneurysm, run by Università Politecnica delle Marche.
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 6 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 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
change in the microvascular flow index (time frame: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)). 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 NCT03510793, which also lists 4 linked publications.
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 3 May 2018.