Microcirculation and Anesthesia in Vascular Surgery
Changes in the Sublingual Microcirculation Following Aortic Surgery Under Balanced or Total Intravenous Anesthesia: a Prospective Observational Study
1 other identifier
observational
40
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2013
Longer than P75 for all trials
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedFirst Submitted
Initial submission to the registry
April 24, 2018
CompletedFirst Posted
Study publicly available on registry
April 27, 2018
CompletedMay 3, 2018
April 1, 2018
4.2 years
April 24, 2018
April 30, 2018
Conditions
Keywords
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
Total intravenous anesthesia
Patients receiving total intravenous anesthesia (TIVA) using propofol + remifentanil with target-controlled infusion according to the attending physician's decision.
Interventions
patients undergoing open elective abdominal aortic aneurysm repair will receive balanced (desflurane + remifentanil) anaesthesia
patients undergoing open elective abdominal aortic aneurysm repair will receive total intravenous (propofol + remifentanil with target-controlled infusion) anesthesia
Eligibility Criteria
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.
PMID: 8388302RESULTKoch 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.
PMID: 18653494RESULTO'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.
PMID: 9059215RESULTLoggi 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.
PMID: 30611197DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abele Donati
Università Politecnica delle Marche
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