- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03470363
Effect of Spinal or Sevoflurane Anesthesia on Neutrophil Activation During Knee Surgery With Pneumatic Tourniquet
March 24, 2020 updated by: Gregory Minguet, University of Liege
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Total knee arthroplasty under spinal or sevoflurane anesthesia
Exclusion Criteria:
- American Society of Anesthesiologists class 3 and 4
- vascular disease of the lower limbs
- cardiac or respiratory disease
- immune disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group Spinal anesthesia
Knee surgery under spinal anesthesia Intervention involves spinal administration of 12,5 mg bupivacaine and 2,5 microgram sufentanil. |
|
Active Comparator: Group Sevoflurane anesthesia
Knee surgery under sevoflurane anesthesia Intervention involves administration of inhaled sevoflurane for maintenance of general anesthesia |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Before surgical incision and 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.
|
Before surgical incision then 3 and 24 hours after tourniquet release
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in plasmatic concentration of endothelial biomarkers
Time Frame: Before surgical incision and one hour after tourniquet release
|
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.
|
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
|
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.
|
Before surgical incision then 3 and 24 hours after tourniquet release
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jean-François Brichant, MD, PhD, University of Liège
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
March 12, 2018
First Submitted That Met QC Criteria
March 16, 2018
First Posted (Actual)
March 19, 2018
Study Record Updates
Last Update Posted (Actual)
March 26, 2020
Last Update Submitted That Met QC Criteria
March 24, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Anesthetics, Inhalation
- Sevoflurane
- Bupivacaine
- Sufentanil
Other Study ID Numbers
- 456
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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