ClinicalTrials.gg
CompletedNCT03470363Updated Mar 26, 2020

Effect of Spinal or Sevoflurane Anesthesia on Neutrophil Activation During Knee Surgery With Pneumatic Tourniquet

An interventional study of Sevoflurane Volatile Liquid and Bupivacaine / SUFentanil in Knee Surgery With Tourniquet, sponsored by University of Liege. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-26.

Sponsored by University of Liege · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jan 2016, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Aim of study : Assessement of neutrophil activation during ischemia reperfusion associated with tourniquet use for total knee arthroplasty. This activation was compared in a group of patient scheduled for spinal anesthesia and for sevoflurane anesthesia

Read the detailed description

Aim of study : Assessement of neutrophil activation during ischemia reperfusion associated with tourniquet use for total knee arthroplasty. This activation was compared in a group of patient scheduled for spinal anesthesia and for sevoflurane anesthesia This activation was assessed by plasma myeloperoxidase and elastase measurements in four consecutive blood samples during and after surgery (before surgical incision and 1, 3, 24 hours following tourniquet release.

02

Conditions studied

  • Knee Surgery With Tourniquet

Keywords

  • total knee arthroplasty
  • tourniquet
  • sevoflurane
  • spinal anesthesia
  • myeloperoxidase
  • elastase
  • neutrophil
03

In context

Lead sponsor

University of Liege is the lead sponsor of 251 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Total knee arthroplasty under spinal or sevoflurane anesthesia

Exclusion criteria

Exclusion Criteria:

  • class 3 and 4
  • vascular disease of the lower limbs
  • cardiac or respiratory disease
  • immune disorder
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Group Spinal anesthesia

    Knee surgery under spinal anesthesia Intervention involves spinal administration of 12,5 mg bupivacaine and 2,5 microgram sufentanil.

    Drug: Bupivacaine / SUFentanil

  • Active comparator
    Group Sevoflurane anesthesia

    Knee surgery under sevoflurane anesthesia Intervention involves administration of inhaled sevoflurane for maintenance of general anesthesia

    Drug: Sevoflurane Volatile Liquid

Interventions

06

What researchers measure

Primary outcomes

  1. Changes in plasmatic concentration of myeloperoxidase and elastase

    Biological measurement of changes in plasmatic concentration of myeloperoxidase and elastase from preoperative values to one hour after tourniquet release.

    Time frame: Before surgical incision and one hour after tourniquet release

  2. Changes in plasmatic concentration of myeloperoxidase and elastase

    Biological measurement of changes in plasmatic concentration of myeloperoxidase and elastase from preoperative values to 3 and 24 hours after tourniquet release.

    Time frame: Before surgical incision then 3 and 24 hours after tourniquet release

Secondary outcomes

  1. Changes in plasmatic concentration of endothelial biomarkers

    Biological measurement of changes in plasmatic concentration of syndecan-1, soluble thrombomodulin, soluble E-selectin and VEGF from preoperative values to one hour after tourniquet release.

    Time frame: Before surgical incision and one hour after tourniquet release

  2. Changes in plasmatic concentration of endothelial biomarkers

    Biological measurement of changes in plasmatic concentration of syndecan-1, soluble thrombomodulin, soluble E-selectin and VEGF from preoperative values to 3 and 24 hours after tourniquet release.

    Time frame: Before surgical incision then 3 and 24 hours after tourniquet release

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2016 to primary completion in Mar 2018, 26 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2018
First posted
Mar 19, 2018
StartActual
Jan 1, 2016
Primary completionActual
Mar 1, 2018
CompletionActual
Mar 1, 2018
Last update
Mar 26, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03470363
Responsible party
Gregory Minguet (Medical Doctor, Anesthesiologist, Principal Investigator, University of Liege) — Principal investigator
First posted
Mar 19, 2018
Start date
Jan 1, 2016
Primary completion
Mar 1, 2018
Completion
Mar 1, 2018
Last update
Mar 26, 2020

Study contacts

Jean-François Brichant, MD, PhD
study chair · University of Liege

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Bupivacaine · Sufentanil

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