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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

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 groups in NCT03510793
Study groupRoleWhat they receive
Balanced anesthesiaPatients receiving balanced anesthesia (desflurane + remifentanil) according to the attending physician's decision
Receives: Drug: balanced anesthesia
Total intravenous anesthesiaPatients 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.

  1. 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)
  1. 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)

  2. change in tissue oxygenation

    Variation in skeletal muscle (thenar eminence) StO2

    Measured: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)

  3. 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.

  1. First posted27 Apr 2018
  2. Study start1 Sep 2013
  3. Primary completion30 Nov 2017
  4. Study completion30 Nov 2017

Resources

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)
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 8388302
  • Koch 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 18653494
  • O'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 9059215
  • Loggi 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

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.

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