Knee Surgery With TourniquetNCT03470363
Effect of Spinal or Sevoflurane Anesthesia on Neutrophil Activation During Knee Surgery With Pneumatic Tourniquet
A study testing Sevoflurane Volatile Liquid and Bupivacaine / SUFentanil in people with Knee Surgery With Tourniquet, run by University of Liege.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Surgery With Tourniquet
- What is being tested?
- Sevoflurane Volatile Liquid and Bupivacaine / SUFentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Mar 2018
- Phase
- Interventional
- 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
Who may be able to join
- Total knee arthroplasty under spinal or sevoflurane anesthesia
Who cannot join
- American Society of Anesthesiologists class 3 and 4
- vascular disease of the lower limbs
- cardiac or respiratory disease
- immune disorder
About this study
Official title: Effect of Spinal or Sevoflurane Anesthesia on Neutrophil Activation After Tourniquet Induced Ischemia-reperfusion in Knee Surgery
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.
- Conditions
- Knee Surgery With Tourniquet
- Being tested
- Sevoflurane Volatile Liquid, Bupivacaine / SUFentanil
- Keywords
- total knee arthroplasty, tourniquet, sevoflurane, spinal anesthesia, myeloperoxidase, elastase, neutrophil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane Volatile LiquidDrug
Bupivacaine / SUFentanilDrug
| Study group | Role | What they receive |
|---|---|---|
| Group Spinal anesthesia | Active comparator | Knee surgery under spinal anesthesia
Intervention involves spinal administration of 12,5 mg bupivacaine and 2,5 microgram sufentanil. Receives: Drug: Bupivacaine / SUFentanil |
| Group Sevoflurane anesthesia | Active comparator | Knee surgery under sevoflurane anesthesia
Intervention involves administration of inhaled sevoflurane for maintenance of general anesthesia Receives: Drug: Sevoflurane Volatile Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before surgical incision and one hour after tourniquet release
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.
Measured: Before surgical incision then 3 and 24 hours after tourniquet release
Secondary outcomes (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 one hour after tourniquet release.
Measured: Before surgical incision and one hour after tourniquet release
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.
Measured: Before surgical incision then 3 and 24 hours after tourniquet release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Jan 2016
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Surgery With TourniquetStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Minguet, University of Liege
- Investigators
- Jean-François Brichant, MD, PhD, Study chair, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470363
- Sponsor's protocol ID
- 456
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2018
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spinal or Sevoflurane Anesthesia on Neutrophil Activation After Tourniquet Induced Ischemia-reperfusion in Knee Surgery
- ClinicalTrials.gov ID
- NCT03470363
- Acronym / sponsor ID
- 456
- Conditions
- Knee Surgery With Tourniquet
- Keywords
- total knee arthroplasty, tourniquet, sevoflurane, spinal anesthesia, myeloperoxidase, elastase, neutrophil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 19 Mar 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.
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
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Spinal anesthesia | Active comparator | Drug: Bupivacaine / SUFentanilKnee surgery under spinal anesthesia Intervention involves spinal administration of 12,5 mg bupivacaine and 2,5 microgram sufentanil. |
| Group Sevoflurane anesthesia | Active comparator | Drug: Sevoflurane Volatile LiquidKnee surgery under sevoflurane anesthesia Intervention involves administration of inhaled sevoflurane for maintenance of general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Total knee arthroplasty under spinal or sevoflurane anesthesia
Key exclusion criteria (4 listed)
- American Society of Anesthesiologists class 3 and 4
- vascular disease of the lower limbs
- cardiac or respiratory disease
- immune disorder
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 |
|---|---|---|
| Sevoflurane Volatile Liquid | Drug | Group Sevoflurane anesthesia |
| Bupivacaine / SUFentanil | Drug | Group Spinal anesthesia |
Primary outcome
Changes in plasmatic concentration of myeloperoxidase and elastase
Time frame: Before surgical incision and one hour after tourniquet release
Biological measurement of changes in plasmatic concentration of myeloperoxidase and elastase from preoperative values to one hour after tourniquet release.
Changes in plasmatic concentration of myeloperoxidase and elastase
Time frame: Before surgical incision then 3 and 24 hours after tourniquet release
Biological measurement of changes in plasmatic concentration of myeloperoxidase and elastase from preoperative values to 3 and 24 hours after tourniquet release.
2 secondary outcomes
Changes in plasmatic concentration of endothelial biomarkers
Time frame: Before surgical incision and one hour after tourniquet release
Changes in plasmatic concentration of endothelial biomarkers
Time frame: Before surgical incision then 3 and 24 hours after tourniquet release
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 26 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Knee Surgery With Tourniquet
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
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.
Jean-François Brichant, MD, PhD study chair
University of Liege
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane Volatile Liquid and Bupivacaine / SUFentanil in people with Knee Surgery With Tourniquet, run by University of Liege.
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 1 inclusion and 4 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 26 Mar 2020. 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?
Changes in plasmatic concentration of myeloperoxidase and elastase (time frame: Before surgical incision and one hour after tourniquet release). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2020.