Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03379103
Status:
COMPLETED
Last Update Posted:
2021-02-25
First Post:
2017-12-14
Brief Title:
Bleeding in Knee Arthroplasty After Preconditioning With Sevoflurane
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Effects on Bleeding in Knee Arthroplasty After Ischemic Preconditioning With Sevoflurane
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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and coagulogram electrolytes and creatinine lactate and glycemia Volume of drainage will be evaluated until drainage is withdrawn and need for transfusion measuring the number of bags of blood concentrate and volume transfused Pain assessment will be done by means of visual analog scale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 Students t-test for evaluation between groups The need for transfusion will be compared by Fishers exact test Pain intensity will be compared by Wilcoxon test for non-parametric data A commercially available statistical package - SPSS version 150 SPSS Inc will be used A value of P 005 will be considered statistically significant
Detailed Description:
The use of pneumatic tourniquet allows a clear surgical field by restricting blood flow to the area to be operated which implies at least intraoperative bleeding but with a high risk of postoperative bleeding
The late bleeding associated with tourniquet use appears to be due to the imbalance between coagulation and fibrinolysis The use of antifibrinolytics such as tranexamic acid and epsilon aminocaproic acid has been shown to reduce postoperative bleeding reducing the need for transfusion of blood components postoperatively without increasing the risk of thromboembolism The effects of tourniquet which can be maintained at intervals of 75 to 100 minutes include elevation in blood pressure while it is insuflated cardiac index elevation during ischemia and its subsequent elevation at the moment of release to the circulation at which time there is also an increase in oxygen consumption as well as the release of CO2 This increase in oxygen consumption is directly related to the time of ischemia
Skeletal muscless ischemia is accompanied by anaerobic glycolysis formation of reactive oxygen species and release of vasoactive factors Inhaled anesthetics such as isoflurane and sevoflurane have been described as possible protective factors for both cardiac and skeletal muscles although the literature still suggests the need for additional studies Its use in the period before the onset of ischemia is called ischemic preconditioning
The objective of this investigation will be to observe the effects of an inhalational anesthetic commonly used in anesthesia on bleeding in the results of coagulation tests and in the consumption of blood components in the postoperative period of knee arthroplasty surgery
Goals
To compare the effects of preconditioning with sevoflurane in total knee arthroplasty surgery by
1 Coagulogram for coagulation times
2 Volume of blood drainage in the postoperative period
3 Need and volume of blood transfusion
4 Dosage of arterial pH lactate and CPK enzyme
5 Immediate postoperative morbidity and up to 30 days postoperatively
Statistic
Data will be presented by descriptive tables and frequency mean and standard deviation or medians and distribution in 25-75 percentiles for data that do not find a normal distribution The Kolmogorov-Smirnov test will determine if there is a normal distribution
Values for hemoglobin hematocrit platelet count arterial blood gas values electrolytes creatinine CPK lactate blood glucose and coagulogram will be compared by analysis of variance ANOVA
The intragroup analyzes will use repeated measures ANOVA and the Dunnett test if there is a significant difference between the moments of the same group since the test may be better considered for comparison with a control preoperative time Between the groups the values will be compared moment by moment with Students t-test
The need for transfusion considering the number of CC bags will be compared by Fishers exact test and its volume by Students t-test Pain intensity in the postoperative period will be evaluated by visual analogue scale and compared by Wilcoxons test for non-parametric data between the time of entry and discharge of RPA A commercially available statistical package - SPSS version 150 SPSS Inc will be used A value of P 005 will be considered statistically significant
Patients will be allocated to the study groups by random number table Briefly generating a list of two-digit numbers determines the order of entry of patients into the study groups A minimum expected difference between the means of the treatments groups established at 500 ml for the required volume of postoperative transfusion standard deviation at 400 ml with test power at 80 and significance level in 5 suggesting a distribution of 15 patients in each group considering losses in 50
The late bleeding associated with tourniquet use appears to be due to the imbalance between coagulation and fibrinolysis The use of antifibrinolytics such as tranexamic acid and epsilon aminocaproic acid has been shown to reduce postoperative bleeding reducing the need for transfusion of blood components postoperatively without increasing the risk of thromboembolism The effects of tourniquet which can be maintained at intervals of 75 to 100 minutes include elevation in blood pressure while it is insuflated cardiac index elevation during ischemia and its subsequent elevation at the moment of release to the circulation at which time there is also an increase in oxygen consumption as well as the release of CO2 This increase in oxygen consumption is directly related to the time of ischemia
Skeletal muscless ischemia is accompanied by anaerobic glycolysis formation of reactive oxygen species and release of vasoactive factors Inhaled anesthetics such as isoflurane and sevoflurane have been described as possible protective factors for both cardiac and skeletal muscles although the literature still suggests the need for additional studies Its use in the period before the onset of ischemia is called ischemic preconditioning
The objective of this investigation will be to observe the effects of an inhalational anesthetic commonly used in anesthesia on bleeding in the results of coagulation tests and in the consumption of blood components in the postoperative period of knee arthroplasty surgery
Goals
To compare the effects of preconditioning with sevoflurane in total knee arthroplasty surgery by
1 Coagulogram for coagulation times
2 Volume of blood drainage in the postoperative period
3 Need and volume of blood transfusion
4 Dosage of arterial pH lactate and CPK enzyme
5 Immediate postoperative morbidity and up to 30 days postoperatively
Statistic
Data will be presented by descriptive tables and frequency mean and standard deviation or medians and distribution in 25-75 percentiles for data that do not find a normal distribution The Kolmogorov-Smirnov test will determine if there is a normal distribution
Values for hemoglobin hematocrit platelet count arterial blood gas values electrolytes creatinine CPK lactate blood glucose and coagulogram will be compared by analysis of variance ANOVA
The intragroup analyzes will use repeated measures ANOVA and the Dunnett test if there is a significant difference between the moments of the same group since the test may be better considered for comparison with a control preoperative time Between the groups the values will be compared moment by moment with Students t-test
The need for transfusion considering the number of CC bags will be compared by Fishers exact test and its volume by Students t-test Pain intensity in the postoperative period will be evaluated by visual analogue scale and compared by Wilcoxons test for non-parametric data between the time of entry and discharge of RPA A commercially available statistical package - SPSS version 150 SPSS Inc will be used A value of P 005 will be considered statistically significant
Patients will be allocated to the study groups by random number table Briefly generating a list of two-digit numbers determines the order of entry of patients into the study groups A minimum expected difference between the means of the treatments groups established at 500 ml for the required volume of postoperative transfusion standard deviation at 400 ml with test power at 80 and significance level in 5 suggesting a distribution of 15 patients in each group considering losses in 50
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None