NCT03772054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

12 months

First QC Date

December 9, 2018

Last Update Submit

December 11, 2019

Conditions

Ischemia Reperfusion Injury

Keywords

Syndecan-1Heparan sulfateThrombomodulinIschemia ReperfusionAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Syndecan-1 levels

    Differences in the concentration of syndecan-1 in blood serum during and after surgery

    At the moment of IV placement (baseline values), during surgery before of tourniquet release (TR), 10, 60 and 90 min minutes after TR

Secondary Outcomes (2)

  • Heparan sulfate levels

    At the moment of IV placement (baseline values), during surgery before of tourniquet release (TR), 10, 60 and 90 min minutes after TR

  • Thrombomodulin

    At the moment of IV placement (baseline values), during surgery before of tourniquet release (TR), 10, 60 and 90 min minutes after TR

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Sevoflurane

EXPERIMENTAL

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

Interventions

SevofluraneDRUG

Inhalation anesthetic agent

Sevoflurane
PropofolDRUG

Intravenous anesthetic agent

Propofol

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico de la Universidad de Chile

Independencia, Santiago Metropolitan, 8380456, Chile

Location

Related Publications (1)

  • 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.

    PMID: 32434495DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Felipe Maldonado, M.D., M.Sc.

    Hospital Clìnico de la Universidad de Chile.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

December 9, 2018

First Posted

December 11, 2018

Study Start

December 20, 2018

Primary Completion

December 11, 2019

Study Completion

December 11, 2019

Last Updated

December 12, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)