|Year : 2018 | Volume
| Issue : 4 | Page : 879-884
Comparison between colloid preload and coload in bone cement implantation syndrome under spinal anesthesia: A randomized controlled trial
Ayca T Dumanlı Özcan1, Elvin Kesimci1, Cemile Altın Balcı2, Orhan Kanbak1, Hülya Kaşıkara1, Abdulkadir But2
1 Department of Anesthesiology and Reanimation, Ankara Ataturk Training and Research Hospital, Ankara, Turkey
2 Department of Anesthesiology and Reanimation, Yildirim Beyazit University, Ankara, Turkey
|Date of Web Publication||18-Dec-2018|
Dr. Ayca T Dumanlı Özcan
Department of Anesthesiology and Reanimation, Ankara Ataturk Training and Research Hospital, Bilkent, Ankara
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Bone cement implantation syndrome (BCIS) is characterized by hypoxia hypotension cardiac arrest. There is not any research that investigated the hemodynamic effects of colloid use during and before cement implantation regarding BCIS development. Aims: We aimed to compare the effects of colloid preloading before or coloading simultaneously at cement implantation on BCIS development and hemodynamic parameters in patients who underwent total knee arthroplasty. Settings and Design: This is a prospective, randomized, clinical trial with the participation of 109 patients over 60 years of age and patients physical status American Society of Anesthesiologists Classes I and II to undergo knee surgery. The patients were administered spinal anesthesia, divided into three groups. Subjects and Methods: The patients in Group I were infused 8 mL/kg hydroxyethyl starch (130/0.4) 20 min before the cement implantation, those in Group II were infused the same simultaneously during cement implantation. Group III was infused 8 mL/kg/h sodium chloride during the anesthesia management. Hemodynamic parameters of the patients were recorded at before and after cement implantation and once the tourniquet was removed. Statistical Analysis Used: The descriptive statistics were presented as the mean ± standard deviation for normally distributed variables, as the median for nonnormally distributed variables, and as the number of cases and (%) for nominal variables. Pearson's Chi-square test and Fisher's exact test were used in the analysis of categorical variables. Results: Compared to the control group, Groups I and II were hemodynamically more stable. The development of moderate hypoxia during cement implantation was significantly different between the study groups (P < 0.05). Conclusions: We suggest that avoiding intravascular volume depletion by using the colloids, particularly in elderly patients, is important for preventing from the BCIS.
Keywords: Bone cement, colloid, hydroxyethyl starch, hypotension, hypoxia
|How to cite this article:|
Dumanlı Özcan AT, Kesimci E, Balcı CA, Kanbak O, Kaşıkara H, But A. Comparison between colloid preload and coload in bone cement implantation syndrome under spinal anesthesia: A randomized controlled trial. Anesth Essays Res 2018;12:879-84
|How to cite this URL:|
Dumanlı Özcan AT, Kesimci E, Balcı CA, Kanbak O, Kaşıkara H, But A. Comparison between colloid preload and coload in bone cement implantation syndrome under spinal anesthesia: A randomized controlled trial. Anesth Essays Res [serial online] 2018 [cited 2019 May 23];12:879-84. Available from: http://www.aeronline.org/text.asp?2018/12/4/879/247637
| Introduction|| |
Bone cement implantation syndrome (BCIS) has been described during various cemented procedures, including knee arthroplasty and vertebroplasty, is primarily a problem associated with the hip replacement. BCIS is a syndrome characterized by hypoxia, hypotension, cardiac rhythm disorders, increased pulmonary vascular resistance, and cardiac arrest. BCIS is classified as follows:
- Grade 1: Moderate hypoxia (SpO2, 94%) or hypotension (fall in systolic blood pressure [SBP] 20%)
- Grade 2: Severe hypoxia (SpO2, 88%) or hypotension (fall in SBP 0.40%) or unexpected loss of consciousness
- Grade 3: Cardiovascular collapse requiring cardiopulmonary resuscitation.
To reduce the risk of developing BCIS, it is recommended to replace the intravascular fluid gap by while maintaining contact with the surgeon for the type of prosthesis, be diligent in high-risk situations and invasively monitor vital parameters. Avoiding intravascular volume, depletion may reduce the extent of the hemodynamic changes in BCIS. BCIS is a syndrome that may develop during cementation progressing with loss of consciousness along with hypoxia, hypotension or both, and also while removing the joint, implanting the prosthesis or in surgical patients for whom cement was used while opening the tourniquet. While BCIS frequently develops during hip replacement surgeries, it was also reported during knee prosthesis surgery and vertebroplasty procedures.
There are several mechanisms suggested playing a role in the development of BCIS. BCIS is believed to occur due to causes, such as monomer-mediated model, histamine release and hypersensitivity, complement activation, and embolic model or due to a combination of all these causes. Concurrent occurrence of various mechanisms supports the hemodynamic changes seen about BCIS.
Moderate volume of colloid preloading is more effective than crystalloids in maintaining cardiac output (CO) and hemodynamic stability in elderly patients. Hydroxyethyl starch (HES) solutions are the most commonly used intravascular volume expanders to replace the perioperative lost blood, ensure hemodynamic stabilization, and optimize tissue oxygenation.
In literature, it is not clear if preloading or coloading is more effective to prevent the patients from BCIS. In the light of this information, in this study, we attempted to compare the effects of colloid preloading before or coloading simultaneously at cement implantation on BCIS development and hemodynamic parameters in patients who underwent total knee arthroplasty.
| Subjects and Methods|| |
This was an observational prospective cohort study. The approval of the Institutional Ethical Committee was obtained at October 4, 2013. A sample size of 105 was calculated taking the power of the study as 80% and level of significance as 5%. It was decided to assess a total of 100 patients, and the study was conducted from November 2014 to August 2016. After obtaining the ethical approval (no: 99950669/1023 no. 25; October 4, 2013) and patient consent, a total of 109 patients between 60 and 65 years of age, who were scheduled to undergo knee replacement surgery and had the American Society of Anesthesiologists (ASA) physical classes I and II, were enrolled.
Participants were randomized into three groups, each Group I included 34, Group II 34, and Group III 41 patients, through sealed envelope method. The exclusion criteria were as follows: Adults who did not provide consent for participation in the study. Patients with uncontrolled hypertension, patients with active and severe renal, hepatic, respiratory or cardiac failure, a history of seizures, a neurological or neuromuscular disorder, chronic pain or analgesic medication use, patients with a platelet count of lower than 100,000 mm3, anatomic malformations and those with a cutaneous infection at injection site were excluded from this study. In addition, operations lasting shorter than 90 min and longer than 240 min were excluded from this study. After standard monitoring, all patients were cannulated through a vein in the dorsum of the hand for the peripheral venous catheter, and 8 mL/kg/h crystalloid solution (İzotonik sodyum klorür solüsyonu, medifleks torbada %0.9 Eczacıbaşı-Baxter Hastane Ürünleri Sanayi ve Ticaret A.Ş. Istanbul) infusion was initiated. Patients were moved to a seated position. After sterile conditions were achieved, a 22-gauge spinal needle (Tmt Tibbi Medikal Malz. San. Tic. Ltd. Şti. Izmir, Turkey) was used to reach the subarachnoid space, and free cerebrospinal fluid flow was observed. Then, all patients were administered 3 cc of 5% bupivacaine (Marcaïne % 0.5, AstraZeneca PLC, İngiltere lisansı ile AstraZeneca İlaç San. ve Tic. Ltd. Şti. İstanbul). Pinprick test was performed to follow sensory block level. The surgical procedure was allowed to begin after the sensory block reaches T10. 8 mL/kg HES (130/0.4) (Voluven, Fresenius Kabi İlaç Sanayi ve Tic. Ltd. Şti. Istanbul, Turkey) bolus infusion was performed 20 min before cement implantation in Group I and at the time of cement implantation in Group II. Group III was infused 8 mL/kg/h sodium chloride during the anesthesia management. Systolic, diastolic, and mean arterial blood pressures (SAP, DAP, MAP), heart rate (HR), respiration number, and peripheral oxygen saturation (SpO2) were recorded at 5-min intervals during the entire operation. Patients were classified in terms of cement implantation syndrome. Hemodynamic parameters were compared between the groups at the 5 min 1 cementation (T7), at the time of cement implantation (T8), 1 min after cement implantation (T9), 2 min after cement implantation (T10), 3 min after cement implantation (TII), 5 min after cement implantation (T12), 10 min after cement implantation (T13), and 15 min after cement implantation (T14), at the time of tourniquet was deflated (T15). 6 mg ephedrine i. v. bolus (Efedrin 50 mg/1 mL Osel İlaç San. ve Tic. A.Ş. Istanbul, Turkey) was administered in case systolic arterial pressure dropped to <90 mmHg or to <75% of baseline, and the dose was repeated if required. 0.5 mg Atropine (Atropin Sulfat Biofarma 1 mg per mL Biofarma İlaç San. ve Tic. A.Ş. Istanbul, Turkey) ıv bolus was administered when HR dro-1 pped to 50 beats/min. The tourniquet was slowly deflated within 2 min after completion of the procedure (T15). The level of block was monitored during postoperative recovery, and the patients were then transferred to the clinics.
The study data were entered into the computer and analyzed using SPSS for Windows version 21.0 (SPSS Inc., Chicago, IL, USA). The descriptive statistics were presented as the mean ± standard deviation for normally distributed variables, as the median (min-max) for nonnormally distributed variables, and as the number of cases and (%) for nominal variables. Pearson's Chi-square test and Fisher's exact test were used in the analysis of categorical variables. The significance of any difference between the mean values of the groups was assessed by analysis of variance (ANOVA). Normal distribution of the variables was tested using visual (histogram and probability graphics) and analytic methods (Kolmogorov–Smirnov/Shapiro-Wilk tests). One-way ANOVA was used to determine any difference between three independent groups in terms of normally distributed variables for which variances were assumed to be homogeneous. Two-way ANOVA (two-way-mixed) was used to detect the differences between the groups for mixed patterns in repeated measures and the change over time in repeated measures. In case there was a significant difference between the groups, post hoc tests were performed to identify the source of difference. For nonnormally distributed variables, Kruskal–Wallis H test was used to determine whether there was a significant difference between three distributions by comparing the measurements for a dependent (repeated measures) variable in three independent groups (samples). In case there was a significant difference between the groups, binary comparisons between two groups were performed by Mann–Whitney U test to identify the source of difference. The statistical significance level for all tests was considered as P < 0.05. As Bonferroni correction was performed in post hoc tests for comparison of three groups, the level of statistical significance was considered as P < 0.017.
| Results|| |
Height, body weight, and body mass index were not significantly different between the study groups (P > 0.05). In addition, the mean age, gender distribution, and ASA classification were similar between the patients in Group I, Group II, and Group III [Table 1].
|Table 1: Distribution of certain descriptive and clinical characteristics of the study groups|
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The SAP of patients at T10 was significantly different between the groups. SAB values measured at T10 of patients in Groups I and II were significantly higher than the values recorded in Group III (P = 0.021).
Compared to SAP values measured at T7, there was a significant difference in SAP values measured at T11 (P = 0.029). The decrease in the SAP of patients in Group III was significantly higher compared to the patients in Group II [Figure 1].
|Figure 1: Systolic arterial blood pressure change over time in study. *SAP: Systolic arterial pressure. T7 (5 min before cementation), T8 (at the time of cement implantation), T9 (1 min after cement implantation (AC)), T10 (2 min AC), T11 (3 min AC), T12 (5 min AC), T13 (10 min AC), T14 (15 min AC), T15 (the time of tourniquet was deflated)|
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There was a significant difference between DAP levels recorded at T7, T14, and T15 (P < 0.001). DAP levels of the patients were significantly different between the groups independent of time of measurement (P < 0.001). Patients in Group II had significantly higher DAP levels over time compared to those in Group III (P < 0.05). There was a significantly higher difference between DAP levels recorded at T7 and T15 (P < 0.001). Appropriate post hoc tests based on homogeneity of the variances were performed to identify the source of difference between the groups [Figure 2].
|Figure 2: Diastolic arterial blood pressure change over time in study groups. *DAP: Diastolic arterial pressure. **T7 (5 min before cementation), T8 (at the time of cement implantation), T9 (1 min after cement implantation (AC)), T10 (2 min AC), T11 (3 min AC), T12 (5 min AC), T13 (10 min AC), T14 (15 min AC), T15 (the time of tourniquet was deflated)|
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There were significant differences between MAP levels recorded at T7 and T13, T14, T15 (P = 0.006, P = 0.039, P = 0.000). MAP values recorded at T7 were significantly lower than the values measured at the other time points.
Compared to MAP values measured T7, the level of change in MAP values at T13 and T15 was significant in at least one of the three groups (P < 0.05). In terms of the change in MAP values recorded at T7, T13, and T15 the decrease in MAP levels of patients in Group III was significantly higher compared to the patients in Groups I and II [Figure 3].
|Figure 3: Mean arterial blood pressure change over time in study groups. *MAP: Mean arterial pressure. **T7 (5 min before cementation), T8 (at the time of cement implantation), T9 (1 min after cement implantation (AC)), T10 (2 min AC), T11 (3 min AC), T12 (5 min AC), T13 (10 min AC), T14 (15 min AC), T15 (the time of tourniquet was deflated)|
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HR values measured at T7, T8, and T14 were significantly different between the groups (P < 0.05). Patients in Groups I and II had significantly higher HR values compared to those in Group III.
Measurements obtained at T9, T11, T12 indicated that the patients in Group I had significantly higher HR compared to patients in Group III (P < 0.05). Compared to the HR recorded at T7, HR values of the patients changed significantly independent of time (P = 0.006, P = 0.001, P = 0.000, P = 0.016, P = 0.018, P = 0.000, P = 0.000, P = 0.001). HR of patients in Groups I and II was significantly higher compared to the patients in Group III.
SpO2 values of the patients, measured at T7, T8 and T10, T11, T13, and T15 were significantly different between the study groups. Except for the measurements recorded at T15, SpO2 values of the patients in Group III were significantly higher than the patients in other groups at all time points. SpO2 values measured at T15 were lower in Group III compared to the other groups. The amount of change in SpO2 values was significantly different between Group II and Group III and between Group I and Group III (P = 0.000). The amount of decrease in SpO2 values of patients in Group III was significantly greater than the patients in other groups [Figure 4].
|Figure 4: The change in heart rate over time in study groups. *HR: Heart rate. **T7 (5 min before cementation), T8 (at the time of cement implantation), T9 (1 min after cement implantation [AC]), T10 (2 min AC), T11 (3 min AC), T12 (5 min AC), T13 (10 min AC), T14 (15 min AC), T15 (the time of tourniquet was deflated)|
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For the entire duration of the study, patients who had at least 20% drop in SAP or those with SpO2 values lower than 94% at any time during the operation were considered to have Grade 1 BCIS. Accordingly, Grade 1 BCIS developed in 20.58% of the patients in Group I (n = 7), 14.71% of patients in Group II (n = 5) and 70.73% of patients in Group III. The occurrence of moderate hypoxia was significantly different between study groups (P < 0.05). Patients in Group III developed Grade 1 BCIS at a significantly higher frequency compared to the patients in other groups [Figure 5].
|Figure 5: The development of moderate hypoxia (Grate 1 BCIS) by study groups. BCIS (−) nondeveloped patients. BCIS (+) developed patients|
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| Discussion|| |
In the present study, colloid loading during cementation positively affected the hemodynamic parameters in both groups, and the effect was more prominent in the coloading group. Grade 1 BCIS was developed in patients in the control group that was infused crystalloids at a significantly higher frequency compared to the groups that received preload or coload colloid.
As a second result, compared to the time points before cementation, the crystalloid group had a hemodynamically more unstable course than the two other groups in this study. Compared to the time point of 5 min before cement implantation, diastolic and mean arterial pressures were significantly higher in both groups, particularly in the coloading group than crystalloid group after the tourniquet was opened. In terms of the change in systolic pressure, the measurements obtained on the 3rd and 2nd min were significantly higher in the coloading group compared to the control group. Moreover, the coloading group had significantly higher diastolic pressures compared to the control group on the 2nd, 10th, and 15th min after cementation. Independent of the time, mean arterial pressure was also significantly higher in the coloading group at the 2nd and the 10th min and at the time of tourniquet opening, compared to the other two groups (P < 0.05). In this study, there were some limitations that it could not be compared the patients' atrial natriuretic peptide (ANP) levels and we could not measure the also Anti-inflammatory effects of the HES.
During BCIS, the patients are considered to experience drop in mean arterial pressure as well as a reduction in stroke volume and CO, particularly due to peripheral vasodilatation, the decreased venous return and increased pulmonary vascular resistance.
Particularly in elderly patients, hypotension results in inadequate organ perfusion and may ultimately end with the loss of consciousness and cardiovascular collapse; the true goal of hemodynamic management during anesthesia is to maintain tissue perfusion. In elderly patients, who receive spinal administration, optimizing cardiac preload may be fundamental to prevent spinal hypotension and organ dysfunction. Colloid increases intravascular volume and stays in the vascular space longer due to the larger molecular weight compared with crystalloid.
ANP is secreted on stretching of the atrial muscles. This eventually results in hypotension and diuresis., Previous studies indicated that, for prevention of spinal-induced hypotension, preloading causes a lower increase in ANP levels, but the levels still elevate 30 min after. Thus, coloading was suggested to be a preferable option as it is not associated with atrial stretching due to spinal-induced vasodilatation. In the present study, since coloading delayed the time of ANP secretion, its effects on hypotension and diuresis did not coincide with the time of cementation. We believe that this is the reason why the hemodynamic parameters remained significantly higher during coloading. A previous study in the literature compared loading before spinal anesthesia and coloading in elective C-section operations. While coloading was performed with 1000 cc crystalloid, preloading with 500 cc colloid was found to have a similar impact on hemodynamic parameters.
Another study argued that preloading with HES solution was not significantly different from the use of normal saline solution.
On the other hand, in line with our findings, Talakoub et al. previously demonstrated that colloid therapy better preserved systolic blood pressure and heartbeat rate compared to crystalloid group.
HES 130/0.4 reduced pro-inflammatory responses and increased anti-inflammatory responses to a greater degree than 4% modified gelatin solution GEL and ISOlyte s ISO. The use of ISO, compared to HES and GEL, resulted in more of a fall in the CD4+: CD8+ ratio, suggesting increased immunosuppression. Due to the anti-inflammatory effects of the HES can be protective against the BCIS.
Findings of another study reported that HES 130/0.4 significantly reduced neutrophil–platelet aggregates, neutrophil extracellular traps formation, chemokine-induced arrest, and transmigration of neutrophils under inflammatory conditions. Results of this study may be explained that HES could be prevent the patients underwent procedures with cement, from the embolic events.
Studies demonstrating that HES induces the anti-inflammatory and immunomodulatory mechanisms suggest that it may also have a favorable effect on the cement reaction. A previous study investigating ischemia-reperfusion injury also found that the xanthine oxidase levels after tourniquet opening were markedly lower in the group treated with HES. Considering the above-detailed advantages, it may also be a preferred option for volume replacement in lower extremity surgeries associated with a risk of BCIS due to the use of a tourniquet.
Future large-scale studies could evaluate the antioxidant and anti-inflammatory effects of HES during surgeries associated with a risk of BCIS, and measure the impact of HES on BCIS.
| Conclusions|| |
It is important that avoiding intravascular volume depletion by the infusing colloids, particularly in elderly patients, is crucial for preventing hemodynamic changes during BCIS.
We thank our colleagues from Ankara Atatürk Research and Training Hospital who provided insight and expertise that greatly assisted the research, although they may not agree with all of the conclusions of this paper.
Financial support and sponsorship
This study was supported by a grant from the T. C. Ministry of Health Ankara Atatürk Research and Training Hospital.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]