NCT03510793

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

4.2 years

First QC Date

April 24, 2018

Last Update Submit

April 30, 2018

Conditions

Keywords

microcirculation; aortic aneurysm; anesthesia

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (3)

  • change in microvascular density

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

  • change in tissue oxygenation

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

  • change in microvascular reactivity

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

Study Arms (2)

Balanced anesthesia

Patients receiving balanced anesthesia (desflurane + remifentanil) according to the attending physician's decision

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.

Drug: Total intravenous anesthesia

Interventions

patients undergoing open elective abdominal aortic aneurysm repair will receive balanced (desflurane + remifentanil) anaesthesia

Balanced anesthesia

patients undergoing open elective abdominal aortic aneurysm repair will receive total intravenous (propofol + remifentanil with target-controlled infusion) anesthesia

Total intravenous anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • elective infrarenal abdominal aortic open repair
  • protocol of intraoperative goal-directed therapy
  • ASA class I-II-III

You may not qualify if:

  • age of less than 18 years
  • pregnancy
  • Endovascular Aneurysm Repair (EVAR)
  • concomitant infections
  • trauma
  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Reperfusion InjuryAortic Aneurysm

Interventions

Balanced Anesthesia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsAneurysmAortic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, GeneralAnesthesiaAnesthesia and Analgesia

Study Officials

  • Abele Donati

    Università Politecnica delle Marche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 24, 2018

First Posted

April 27, 2018

Study Start

September 1, 2013

Primary Completion

November 30, 2017

Study Completion

November 30, 2017

Last Updated

May 3, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share