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Bleeding in Knee Arthroplasty After Preconditioning With Sevoflurane

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ClinicalTrials.gov Identifier: NCT03379103
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Joaquim Edson Vieira, University of Sao Paulo General Hospital

Brief Summary:
Knee arthroplasty is performed with restriction of blood flow by use of the pressure tourniquet. Ischemia of skeletal musculature is accompanied by the formation of reactive oxygen species and release of vasoactive factors. Inhaled anesthetics were described as possible protective factors, termed "ischemic preconditioning". The objective of this investigation is to observe the effects of preconditioning with inhaled anesthetic on bleeding in the postoperative period of knee arthroplasty surgery. The study will be prospective and randomized. Patients will be allocated by means of a randomized table in two groups: Group Preconditioning (GP) - subarachnoid and general anesthesia with preconditioning with 1 minimal alveolar concentration (MAC) for 15 minutes before the installation of the ischemia by tourniquet; Group control (GC) - subarachnoid and general anesthesia with sevoflurane without preconditioning. Will be evaluated: hemoglobin and hematocrit, platelet count and coagulogram, electrolytes and creatinine, lactate and glycemia. Volume of drainage will be evaluated until drainage is withdrawn and need for transfusion measuring the number of bags of blood concentrate and volume transfused. Pain assessment will be done by means of visual analog scale. Morbidity will be recorded up to the 30th postoperative day by chart analysis. Patients will be allocated to the study groups by random number table. Data will be presented descriptively, frequently, mean and standard deviation, or medians and distribution in 25-75% percentiles. The comparison between continuous measurements will be made by means of repeated measures intra-group analysis of variance (ANOVA) and Student's t-test for evaluation between groups. The need for transfusion will be compared by Fisher's exact test. Pain intensity will be compared by Wilcoxon test for non-parametric data. A commercially available statistical package - SPSS version 15.0 (SPSS Inc.) will be used. A value of P <0.05 will be considered statistically significant.

Condition or disease Intervention/treatment Phase
Blood Loss, Surgical Blood Transfusion Drug: Sevoflurane Drug: Propofol Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be allocated by means of a randomized table in 2 groups:

GP - patients will be anesthetized with sevoflurane associated with subarachnoid anesthesia and will be preconditioned with 1 MAC sevoflurane for 15 minutes before the installation of ischemia by tourniquete

GC - patients will be anesthetized with sevoflurane associated with subarachnoid anesthesia

Masking: Single (Outcomes Assessor)
Masking Description: Statistical analysis will not open label for group allocation
Primary Purpose: Treatment
Official Title: Effects on Bleeding in Knee Arthroplasty After Ischemic Preconditioning With Sevoflurane
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GP - sevoflurane
GP - patients will be anesthetized with sevoflurane associated with subarachnoid anesthesia and will be preconditioned with 1 MAC sevoflurane for 15 minutes before the installation of ischemia by tourniquete
Drug: Sevoflurane
Patients will receive 1 MAC sevoflurane for 15 minutes before the installation of member ischemia by tourniquete

Placebo Comparator: GC - control
GC - patients will be anesthetized with sevoflurane associated with subarachnoid anesthesia and will be preconditioned with intravenous propofol for 15 minutes before the installation of ischemia by tourniquete.
Drug: Propofol
Patients will receive propofol for 15 minutes before the installation of member ischemia by tourniquete




Primary Outcome Measures :
  1. Blood loss [ Time Frame: 24 hours ]
    Volume of blood drainage in the postoperative period;


Secondary Outcome Measures :
  1. Blood transfusion [ Time Frame: 24 hours ]
    Need and volume of blood transfusion;

  2. Morbidity [ Time Frame: 30 days ]
    Immediate postoperative morbidity and up to 30 days postoperatively.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • indication for knee arthroplasty

Exclusion Criteria:

  1. Physical state according to classification from American Association of Anesthesiologists (ASA) III or higher,
  2. Obesity (body mass index, BMI, greater than 30),
  3. Renal insufficiency - patients on a dialysis program or with a serum creatinine level above 1.4 mg / dL,
  4. Hematocrit less than 30% or hemoglobin less than 10g / dL,
  5. Records of myocardial infarction during the last 6 months, unstable angina pectoris,
  6. History of coagulation disorders,
  7. Use of oral anticoagulants (coumarins), heparin or acetylsalicylic acid in the last 5 days.

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): NCT03379103


Contacts
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Contact: Ricardo Laurino, MD 55 11 3061 8716 kadao@usp.br

Locations
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Brazil
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo Recruiting
São Paulo, Brazil, 01246-903
Contact: joaquim vieira, MD    55-11-30618716      
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Joaquim E Vieira, MD, PhD University of Sao Paulo School of Medicine

Publications of Results:

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Responsible Party: Joaquim Edson Vieira, Associate Professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03379103     History of Changes
Other Study ID Numbers: CAAE 03735612.7.0000.0068
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

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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 Joaquim Edson Vieira, University of Sao Paulo General Hospital:
Blood Loss, Surgical
Blood Transfusion
Arthroplasty, Replacement, Knee

Additional relevant MeSH terms:
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Sevoflurane
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation