Bleeding in Knee Arthroplasty After Preconditioning With Sevoflurane

NCT03379103 | Completed

• 1 other identifier: CAAE 03735612.7.0000.0068
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 Volume of drainage will be evaluated until drainage is withdrawn and need for transfusion measuring the number of bags of blood concentrate and volume transfused.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.

Conditions

Blood Loss, Surgical; Blood Transfusion

Keywords

Blood Loss, Surgical; Blood Transfusion; Arthroplasty, Replacement, Knee; anesthetic preconditioning

Outcome Measures

Primary Outcomes (1)

• Blood loss

  Volume of blood drainage in the postoperative period;

  24 hours

Secondary Outcomes (2)

• Blood transfusion

  24 hours

• Morbidity

  30 days

Study Arms (2)

GP - sevoflurane

ACTIVE COMPARATOR

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

GC - control

PLACEBO COMPARATOR

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

Interventions

Sevoflurane DRUG

Patients will receive 1 MAC sevoflurane for 15 minutes before the installation of member ischemia by tourniquete

GP - sevoflurane

Propofol DRUG

Patients will receive propofol for 15 minutes before the installation of member ischemia by tourniquete

GC - control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• indication for knee arthroplasty

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 01246-903, Brazil

Location

Related Publications (11)

• Burkart BC, Bourne RB, Rorabeck CH, Kirk PG, Nott L. The efficacy of tourniquet release in blood conservation after total knee arthroplasty. Clin Orthop Relat Res. 1994 Feb;(299):147-52.

  PMID: 8119009 RESULT

• Cid J, Lozano M. Tranexamic acid reduces allogeneic red cell transfusions in patients undergoing total knee arthroplasty: results of a meta-analysis of randomized controlled trials. Transfusion. 2005 Aug;45(8):1302-7. doi: 10.1111/j.1537-2995.2005.00204.x.

  PMID: 16078916 RESULT

• Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12.

  PMID: 19007970 RESULT

• Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873.

  PMID: 22623147 RESULT

• Girardis M, Milesi S, Donato S, Raffaelli M, Spasiano A, Antonutto G, Pasqualucci A, Pasetto A. The hemodynamic and metabolic effects of tourniquet application during knee surgery. Anesth Analg. 2000 Sep;91(3):727-31. doi: 10.1097/00000539-200009000-00043.

  PMID: 10960408 RESULT

• Carles M, Dellamonica J, Roux J, Lena D, Levraut J, Pittet JF, Boileau P, Raucoules-Aime M. Sevoflurane but not propofol increases interstitial glycolysis metabolites availability during tourniquet-induced ischaemia-reperfusion. Br J Anaesth. 2008 Jan;100(1):29-35. doi: 10.1093/bja/aem321. Epub 2007 Nov 20.

  PMID: 18029344 RESULT

• Kersten JR, Schmeling TJ, Pagel PS, Gross GJ, Warltier DC. Isoflurane mimics ischemic preconditioning via activation of K(ATP) channels: reduction of myocardial infarct size with an acute memory phase. Anesthesiology. 1997 Aug;87(2):361-70. doi: 10.1097/00000542-199708000-00024.

  PMID: 9286901 RESULT

• Cram P, Vaughan-Sarrazin MS, Wolf B, Katz JN, Rosenthal GE. A comparison of total hip and knee replacement in specialty and general hospitals. J Bone Joint Surg Am. 2007 Aug;89(8):1675-84. doi: 10.2106/JBJS.F.00873.

  PMID: 17671004 RESULT

• Holte K, Kristensen BB, Valentiner L, Foss NB, Husted H, Kehlet H. Liberal versus restrictive fluid management in knee arthroplasty: a randomized, double-blind study. Anesth Analg. 2007 Aug;105(2):465-74. doi: 10.1213/01.ane.0000263268.08222.19.

  PMID: 17646507 RESULT

• Brookenthal KR, Freedman KB, Lotke PA, Fitzgerald RH, Lonner JH. A meta-analysis of thromboembolic prophylaxis in total knee arthroplasty. J Arthroplasty. 2001 Apr;16(3):293-300. doi: 10.1054/arth.2001.21499.

  PMID: 11307125 RESULT

• Whitley E, Ball J. Statistics review 4: sample size calculations. Crit Care. 2002 Aug;6(4):335-41. doi: 10.1186/cc1521. Epub 2002 May 10.

  PMID: 12225610 RESULT

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Joaquim E Vieira, MD, PhD

  University of Sao Paulo School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistical analysis will not open label for group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 20, 2017
• Study Start: February 2, 2018
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

BR (1)