Sevoflurane vs Propofol Effect on Endothelial Damage Markers After Knee Ligament Surgery.
NCT ID: NCT03772054
Last Updated: 2019-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2018-12-20
2019-12-11
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
Propofol
Intravenous anesthetic agent
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.
Sevoflurane
Inhalation anesthetic agent
Interventions
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Sevoflurane
Inhalation anesthetic agent
Propofol
Intravenous anesthetic agent
Eligibility Criteria
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Inclusion Criteria
* Elective knee ligament surgery
* Use of a femoral tourniquet
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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University of Chile
OTHER
Responsible Party
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Felipe Andrés Maldonado Caniulao
Instructor
Principal Investigators
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Felipe Maldonado, M.D., M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Hospital Clìnico de la Universidad de Chile.
Locations
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Hospital Clínico de la Universidad de Chile
Independencia, Santiago Metropolitan, Chile
Countries
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References
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Maldonado F, Morales D, Gutierrez R, Barahona M, Cerda O, Caceres M. Effect of sevoflurane and propofol on tourniquet-induced endothelial damage: a pilot randomized controlled trial for knee-ligament surgery. BMC Anesthesiol. 2020 May 20;20(1):121. doi: 10.1186/s12871-020-01030-w.
Other Identifiers
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903/17
Identifier Type: -
Identifier Source: org_study_id