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Sevoflurane vs Propofol Effect on Endothelial Damage Markers After Knee Ligament Surgery.

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ClinicalTrials.gov Identifier: NCT03772054
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Felipe Andrés Maldonado Caniulao, University of Chile

Brief Summary:
Endothelial damage has been reported after ischemia-reperfusion events. This can be characterized by measurements of glycocalyx and endothelial components that are released to blood after the insult. Sevoflurane and inhaled anesthetic commonly used for surgery have shown protective endothelial effects in animal and in-vitro models. Knee-ligament surgery with the use of a femoral tourniquet generates a transient ischemia-reperfusion (IR) state after the tourniquet is released. This research aims to compare the effect of sevoflurane and propofol in the release of glycocalyx and endothelial biomarkers after IR in this surgical scenario.

Condition or disease Intervention/treatment Phase
Ischemia Reperfusion Injury Drug: Sevoflurane Drug: Propofol Not Applicable

Detailed Description:

To study the anesthetics effect on the endothelial damage induced by Ischemia-reperfusion (IR) in knee-ligament surgery, we will perform a randomized controlled clinical trial comparing the concentrations of syndecan-1 and heparan sulfate, both markers of superficial glycocalyx shedding and the concentration of thrombomodulin, a marker of endothelial cell damage, in serum of patients under hypnosis with sevoflurane or propofol after a spinal anesthesia.

After ethical review board approval and patients consent, 16 subjects (8 per group) scheduled for Knee-ligament replacement will be randomly allocated in one of the two parallel arms of the study. All patients will enter the operating room and after standard ASA monitorization and placement of an intravenous line (IV), a spinal anesthesia will be performed under midazolam sedation. After analgesia and motor block establishment, an intravenous or inhalation hypnosis induction will be performed (according to the study arm allocation). The airway will be secured by a laryngeal mask placement and the surgery will be started. A femoral tourniquet will be installed and inflated by surgeon indication at 100-120 mmHg over patient systolic blood pressure. Blood samples to measure endothelial damage biomarkers will be taken in five different moments to follow concentration changes before and after the IR insult. Fluid and drugs administration will be standardized.

Venous blood samples will be collected at the moment of IV placement (baseline values), during surgery before of tourniquet release (TR), 10, 60 and 90 min minutes after TR. After obtaining all samples, serum syndecan-1, heparan sulfate, and thrombomodulin will be measured by a researcher blinded to patient allocation using commercial available Elisa kits. The concentration of each biomarker at each sample time will be compared.

A sample size calculation was performed based on a few clinical reports to detect a 25% reduction in the mean concentration of syndecan-1 in the sevoflurane group with an alpha of 0,05 and a power of 80%. Then 16 patients (8 patients per arm) will be enrolled for a two-sides test analysis.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Blood samples will be codified by the principal investigator. Laboratory team will receive all samples for biomarkers measures. Results will be analyzed by the principal investigator.
Primary Purpose: Prevention
Official Title: Sevoflurane vs Propofol Effect on Endothelial Damage Markers After Knee Ligament Surgery. A Randomized Controlled Trial
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Propofol
After spinal anesthesia, patients in this arm will receive an intravenous target controlled infusion to site effect (TCI/Ce) infusion of propofol to achieve hypnosis guided to a bispectral index (BIS) level of 40-60 during surgery.
Drug: Propofol
Intravenous anesthetic agent

Experimental: Sevoflurane
After spinal anesthesia, patients in this arm will receive an inhalation induction with sevoflurane to achieve hypnosis guided to 0.7-0.9 minimum alveolar concentration (MAC) during surgery.
Drug: Sevoflurane
Inhalation anesthetic agent




Primary Outcome Measures :
  1. Syndecan-1 levels [ Time Frame: At the moment of IV placement (baseline values), during surgery before of tourniquet release (TR), 10, 60 and 90 min minutes after TR ]
    Differences in the concentration of syndecan-1 in blood serum during and after surgery


Secondary Outcome Measures :
  1. Heparan sulfate levels [ Time Frame: At the moment of IV placement (baseline values), during surgery before of tourniquet release (TR), 10, 60 and 90 min minutes after TR ]
    Differences in the concentration of heparan sulfate in blood serum during and after surgery

  2. Thrombomodulin [ Time Frame: At the moment of IV placement (baseline values), during surgery before of tourniquet release (TR), 10, 60 and 90 min minutes after TR ]
    Differences in the concentration of thrombomodulin in blood serum during and after surgery



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists Classification (ASA Class) I and II
  • Elective knee ligament surgery
  • Use of a femoral tourniquet

Exclusion Criteria:

  • Allergies to egg or soya
  • Previous history of critical events during surgery and perioperative period
  • Patients at risk of hyperthermia malignant
  • Patients with 3 or more predictor of difficult airway management

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772054


Contacts
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Contact: Felipe Maldonado, M.D., M.Sc. +56 2 2978 8221 fmaldonado@uchile.cl

Locations
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Chile
Hospital Clínico de la Universidad de Chile Recruiting
Independencia, Santiago, Chile, 8380456
Contact: Felipe Maldonado, M.D., M.Sc.         
Sponsors and Collaborators
University of Chile
Investigators
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Principal Investigator: Felipe Maldonado, M.D., M.Sc. Hospital Clìnico de la Universidad de Chile.

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Responsible Party: Felipe Andrés Maldonado Caniulao, Instructor, University of Chile
ClinicalTrials.gov Identifier: NCT03772054     History of Changes
Other Study ID Numbers: 903/17
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Felipe Andrés Maldonado Caniulao, University of Chile:
Syndecan-1
Heparan sulfate
Thrombomodulin
Ischemia Reperfusion
Anesthesia

Additional relevant MeSH terms:
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Sevoflurane
Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation