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Comparative study of the effect of two different doses of remifentanil on bleeding control in lumbar fusion surgery: A randomized clinical trial
Hashemiyazdi SH, Masoudifar M, Rahimi Z, Honarmand A, Aryafar M
Annals of medicine and surgery (2012). 2022;82:104761
Abstract
OBJECTIVES Spinal fusion surgery completely prevents movement or friction between the two vertebrae. Remifentanil, a selective drug agonist, suppresses and decreases the vasomotor system upon release of histamine. In this study, the efficacy of remifentanil infusion at doses of 0.1 and 0.3 μg/kg/min in the control of low blood pressure was compared. METHODS In this randomized clinical trial, 110 candidates for selective spinal fusion surgery were entered and randomized into 2 groups. The first group received 0.1 μg/kg/min and in the second group 0.3 μg/kg/min remifentanil. The systolic and diastolic blood pressure, pulse rate, SPO2, and surgeon's satisfaction were measured and compared between groups. RESULTS the systolic blood pressure was significantly lower in patients receiving 0.3 μg of remifentanil by the time 30, 45, 60, and 90 min during the surgeries (P < 0.05). No significant difference was observed in terms of PR (P = 0.19) and SPO2 (P = 0.41) between the two groups. We also observed significantly higher duration of surgeries (P = 0.002), duration of anesthesia (P = 0.009), significantly higher bleeding volume (P < 0.001), higher fluid intake (P = 0.01) and higher transfused blood (P = 0.01) in patients that received 0.1 μg remifentanil compared to other patients. CONCLUSION Here we showed that administration of 0.3 μg/kg/min remifentanil was associated with significantly lower systolic blood pressure during the surgeries. On the other hand, patients that received 0.1 μg/kg/min remifentanil had significantly higher duration of surgeries, duration of anesthesia, significantly higher bleeding volume, higher fluid intake, and also higher transfused blood.
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2.
Effects of esmolol continuous infusion on blood loss in patients undergoing posterior lumbar internal fixation surgery: A prospective randomized study
Moon YE, Joo MA, Joo J
The Journal of international medical research. 2022;50(3):3000605221078705
Abstract
OBJECTIVE To determine the intravenous (i.v.) dose of esmolol needed to attenuate blood loss in patients undergoing posterior lumbar internal fixation (PLIF) surgery. METHODS This study randomized patients to either the E5 or E10 group. Patients in the E5 group received a 0.25 mg/kg i.v. loading dose of esmolol before anaesthesia, followed by an infusion of 5 µg/kg/min throughout the operation. Patients in the E10 group received a 0.5 mg/kg i.v. loading dose of esmolol before anaesthesia, followed by an infusion of 10 µg/kg/min throughout the operation. RESULTS The study analysed 33 patients: 16 in the E5 group and 17 in the E10 group. The mean ± SD blood loss at the end of surgery was significantly greater in the E5 than E10 group (586.3 ± 160.1 versus 347.7 ± 138.0 ml, respectively). The total amount of patient-controlled analgesia (PCA) used was significantly higher in the E5 than E10 group at 8 (26.1 ± 12.0 versus 17.5 ± 8.3 ml, respectively), 24 (58.4 ± 21.3 versus 44.1 ± 16.2 ml, respectively) and 48 h after surgery (90.0 ± 22.5 versus 69.3 ± 22.1 ml, respectively). CONCLUSION A continuous infusion of 10 µg/kg/min of esmolol can safely reduce blood loss during PLIF surgery. It was also shown to reduce postoperative PCA consumption.
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Comparing the Effect of Clonidine and Dexmedetomidine on Intraoperative Bleeding in Spine Surgery
Janatmakan F, Nesioonpour S, Javaherforoosh Zadeh F, Teimouri A, Vaziri M
Anesthesiology and pain medicine. 2019;9(1):e83967
Abstract
Background: Discopathy is one of the most common spinal surgeries. Hemodynamic control is important in bleeding reduction during the surgery. Clonidine and dexmedetomidine both are alpha(2) agonists that help stabilize hemodynamics and prevent the increase of intraoperative bleeding. Objectives: In this study, the effects of clonidine and dexmedetomidine were compared in bleeding reduction during spinal surgery. Methods: This randomized, double-blind clinical trial was conducted in 120 patients aged 20 to 50 years with ASA class I or II, undergoing spinal surgery. Patients were randomly divided into three groups. Group C received oral clonidine 0.2 mg, 90 minutes before entering the room. Group D received dexmedetomidine 0.5 micro/kg 15 minutes before anesthesia induction and 0.25 micro/kg/h infusion during operation. Group P received placebo as the control group. Results: There was a significant reduction in intraoperative blood loss in patients who received clonidine (289 +/- 130) and dexmedetomidine (344 +/- 145) compared to the control group (462 +/- 15) (P < 0.05), with a more dramatic reduction in the clonidine group (P < 0. 001).
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Dabigatran reversal by idarucizumab in the setting of intracranial hemorrhage: A systematic review of the literature
Lu VM, Phan K, Rao PJ, Sharma SV, Kasper EM
Clinical neurology and neurosurgery. 2019;181:76-81
Abstract
Idarucizumab is the first Food and Drugs Administration (FDA) approved reversal agent for anticoagulant dabigatran, a direct thrombin inhibitor. Emerging evidence suggests idarucizumab can improve clinical outcome following dabigatran-associated hemorrhage, however, its specific use in intracranial hemorrhage has been poorly described. The aim of this study was to systematically review the available literature of idarucizumab in the setting of dabigatran-associated ICH to evaluate its efficacy in the stabilizing/resolving of the primary hemorrhage. A systematic search of 7 electronic databases from their earliest records to August 2018 was conducted following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. There were 864 articles identified for screening against selection criteria. The search identified 9 articles to be included in our analysis, describing hemorrhage outcomes in 23 dabigatran-associated cases of ICH managed by idarucizumab. Mean overall age was 76.2 years, with 43% females, and bleeding was subdural, subarachnoid and intracerebral in 43%, 13% and 43% cases respectively. Surgical intervention was pursued in 48% of cases. During the course of the hospitalization, the hemorrhages stabilized/resolved in 87% of patients, and worsened in 13%. In-hospital complications occurred in 4% of cases, and mortality occurred in 4% of cases as well. The available literature suggests that idarucizumab can be applied in the setting of ICH, for its therapeutic effect in patients presenting with dabigatran-associated ICH appears acceptable with no compromise to clinical safety. However, currently there is a paucity of data about various aspects that are involved in other aspects of ICH treatment, including recovery, that limits the significance of the current literature. As more evidence is published relating specifically to long-term ICH outcomes that have been treated by idarucizumab, we will be better placed to establish the optimal role of idarucizumab in the setting of dabigatran-associated ICH.
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High-volume, Multilevel Local Anesthetics-Epinephrine Infiltration in Kyphoscoliosis Surgery: Blood Conservation
Mazy A, Elmaadawy AEA, Serry M, Kassem M
Anesthesia, essays and researches. 2019;13(3):405-410
Abstract
Introduction: Scoliosis surgery is usually associated with severe bleeding. Various systemic strategies for blood conservation were applied, while the local techniques get less attention. The preemptive use of sufficient volume for proper tissue infiltration at two levels was applied. The local epinephrine may control bleeding without reliance upon deliberate hypotension, permitting a higher tissue perfusion. Materials and Methods: This prospective study included 46 patients scheduled for posterior spinal fusion for scoliosis correction. Patients were randomized into two groups. group I received a cocktail of high volume (100 ml/each 10 cm of wound length) of local anesthetics and epinephrine tumescent infiltration at the subcutaneous (SC) followed by intramuscular level bilaterally. Group C received saline infiltration in the same technique. Statistically, data were analyzed according to its distribution using the t-test, Mann-Whitney, and Chi-square tests as appropriate. Results: There was a significant reduction in blood loss (38%), reduced blood and fluid transfusion (36% and 23%), and reduced operative time (23%), with higher surgeon satisfaction. The surgical field visibility (Fromme's scale) was much better during SC and muscular dissection in Group I, while it was fair during the bony work. The satisfactory field in spite of higher mean blood pressure in Group I greatly omitted the reliance upon deliberate hypotension. Conclusion: The high-volume multilevel infiltration of epinephrine cocktail can provide a significant blood and operative time conservation in kyphoscoliosis surgery.
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Surgical Performance Determines Functional Outcome Benefit in the Minimally Invasive Surgery Plus Recombinant Tissue Plasminogen Activator for Intracerebral Hemorrhage Evacuation (MISTIE) Procedure
Awad IA, Polster SP, Carrion-Penagos J, Thompson RE, Cao Y, Stadnik A, Money PL, Fam MD, Koskimaki J, Girard R, et al
Neurosurgery. 2019
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Abstract
BACKGROUND Minimally invasive surgery procedures, including stereotactic catheter aspiration and clearance of intracerebral hemorrhage (ICH) with recombinant tissue plasminogen activator hold a promise to improve outcome of supratentorial brain hemorrhage, a morbid and disabling type of stroke. A recently completed Phase III randomized trial showed improved mortality but was neutral on the primary outcome (modified Rankin scale score 0 to 3 at 1 yr). OBJECTIVE To assess surgical performance and its impact on the extent of ICH evacuation and functional outcomes. METHODS Univariate and multivariate models were used to assess the extent of hematoma evacuation efficacy in relation to mRS 0 to 3 outcome and postulated factors related to patient, disease, and protocol adherence in the surgical arm (n = 242) of the MISTIE trial. RESULTS Greater ICH reduction has a higher likelihood of achieving mRS of 0 to 3 with a minimum evacuation threshold of ≤15 mL end of treatment ICH volume or ≥70% volume reduction when controlling for disease severity factors. Mortality benefit was achieved at ≤30 mL end of treatment ICH volume, or >53% volume reduction. Initial hematoma volume, history of hypertension, irregular-shaped hematoma, number of alteplase doses given, surgical protocol deviations, and catheter manipulation problems were significant factors in failing to achieve ≤15 mL goal evacuation. Greater surgeon/site experiences were associated with avoiding poor hematoma evacuation. CONCLUSION This is the first surgical trial reporting thresholds for reduction of ICH volume correlating with improved mortality and functional outcomes. To realize the benefit of surgery, protocol objectives, surgeon education, technical enhancements, and case selection should be focused on this goal.
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The beneficial effect of Batroxobin on blood loss reduction in spinal fusion surgery: a prospective, randomized, double-blind, placebo-controlled study
Hu, H. M., Chen, L., Frary, C. E., Chang, C. C., Hui, H., Zhang, H. P., Huang, D. G., Liu, Z. K., Zhao, Y. T., He, S. M., et al
Archives of Orthopaedic and Trauma Surgery. 2015;135(4):491-7
Abstract
OBJECTIVE Our objective was to evaluate the efficacy and safety of Batroxobin on blood loss during spinal operations. METHODS After obtaining approval from the ethics committee at the hospital along with informed written consent, we performed a double-blind, randomized, placebo-controlled study with 100 patients who were randomized equally into 2 groups (Batroxobin and placebo). Patients received either 2 ku IV 15 min before surgery and followed 1 ku IM of Batroxobin following surgery, or an equivalent volume of placebo (normal saline). Cost of Batroxobin treatment is amounted to 84.75 euros. The primary outcomes were intraoperative, 24 h postoperative, and total perioperative blood loss. Secondary outcomes were hemoglobin (Hb), red blood cell count (RBC), the volume of blood/fluid transfusion intraoperatively, and 24 h postoperatively. Safety evaluation parameters were the incidence of venous thrombosis in the lower extremities, active partial thromboplastin time, prothrombin time, thrombin time, and fibrinogen. The data were analyzed using the Statistical Package for the Social Science Version 12.0. The results were presented as mean ± SEM. The Mann-Whitney test and Independent Student t test, when appropriate, were used to compare the 2 groups, and differences were considered significant if the P value was <0.05. RESULTS 88 patients were included in the analysis while 12 patients were withdrawn from the study due to extended surgical duration, change of surgical procedure, or after the patients' request. The total perioperative blood loss was approximately 31% lower in patients given Batroxobin versus placebo (700.5 ± 45.81 vs 485.7 ± 30.01 mL, P = 0.001). The Batroxobin group had significantly less intraoperative blood loss (326.1 ± 24.16) compared to the placebo group (556.0 ± 43.58), but there was no difference in the amount of blood/fluid transfused, postoperatively Hb, or RBC between the two groups. After the operation, coagulation parameters were not significantly different between the 2 groups at the days 1 or 3 postoperatively. No adverse events related to the use of Batroxobin were recorded. There were no cases of superficial wound infection. None of the subjects died during the study. CONCLUSIONS In this study, prophylactic use of Batroxobin provided an effective and cheap method for reducing blood loss without coagulopathy during or after operations. The use of Batroxobin for patients undergoing one-level PLIF surgery safely and effectively reduced the total amount of perioperative blood loss.
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Effects of deamino-8-D-arginin vasopressin on blood loss and coagulation factors in scoliosis surgery. A double-blind randomized clinical trial
Alanay A, Acaroglu E, Ozdemir O, Ercelen O, Bulutcu E, Surat A
Spine. 1999;24((9):):877-82.
Abstract
STUDY DESIGN A double-blind, randomized, prospective clinical study was performed to evaluate the efficacy of deamino-8-D-arginin vasopressin in reducing blood loss in major scoliosis surgery. OBJECTIVES To evaluate whether desmopressin has any effect on reducing blood loss in spinal surgery, to identify the probable mechanisms of effectiveness via blood coagulation factors, and to outline any adverse effect associated with the use of deamino-8-D-arginin vasopressin. SUMMARY OF BACKGROUND DATA Scoliosis surgery is known to be associated with major blood loss. Because of major drawbacks of homologous blood transfusion, many alternative methods have been used to counter the blood loss. Only a few studies exist, with controversial results, on the use of deamino-8-D-arginin vasopressin. METHODS The study population included 40 operations on 35 consecutive patients undergoing reconstructive surgery for either idiopathic (n = 26) or congenital (n = 9) scoliosis. Operations were randomized into deamino-8-D-arginin vasopressin (0.3 microgram/kg body weight; maximum, 20 micrograms) (n = 18) or placebo (n = 22) groups and stratified according to the diagnosis and the type of surgery performed (i.e., anterior versus posterior versus anterior and posterior sequential). Parameters of blood loss, serum levels of blood coagulation factors at different time intervals, and urinary output were measured. RESULTS Findings indicated that blood loss per kilogram of body weight, blood loss per surgically treated spinal level, urinary output per kilogram of body weight and serum levels of fibrinogen, von Willebrand factor (vWF) activity, tissue type plasminogen activator activity, and plasminogen activator inhibitor activity were not sensitive to the administration of deamino-8-D-arginin vasopressin at any time interval during surgery or at 24 hours after surgery (P > 0.05). Only factor VIIIC levels exhibited significant elevations at 30 minutes and at 24 hours (P < 0.05). CONCLUSIONS This study could not demonstrate any significant effect of deamino-8-D-arginin vasopressin on the amount of blood loss in a group of patients with idiopathic or congenital scoliosis. Findings indicate that for most of the coagulation factors, any changes in serum levels induced by deamino-8-D-arginin vasopressin were much like those expected from surgery itself. This study also failed to demonstrate any significant effects altering the urinary output that may be attributed to the use of deamino-8-D-arginin vasopressin.
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The influence of desmopressin on blood loss during spinal fusion surgery in neuromuscular patients
Letts M, Pang E, D'Astous J, Jarvis J, Lawton L, Luke B, Rhine E, Menard E
Spine. 1998;23((4):):475-8.
Abstract
STUDY DESIGN A double-blind study comparing the effects of desmopressin and a placebo (normal saline) on blood loss during spinal instrumentation for neuromuscular scoliosis. OBJECTIVE To determine the effectiveness of desmopressin acetate (DDAVP) in reducing operative blood loss in hemostatically normal patients undergoing spinal fusion surgery for neuromuscular scoliosis. SUMMARY OF BACKGROUND DATA Desmopressin acetate has been shown to improve bleeding times and to provide surgical hemostasis in patients with platelet disorders. Its effect in reducing bleeding times in normal patients has been the subject of debate in several surgical specialties. Recent observations that DDAVP seems to reduce bleeding times and blood loss in patients undergoing spinal surgery for neuromuscular scoliosis warranted a more focused analysis on its role in this surgical procedure. METHODS Patients undergoing surgery for neuromuscular scoliosis were randomly assigned to receive DDAVP or placebo. Bleeding times and plasma clotting factors were measured before the administration of the DDAVP or placebo and 60 minutes after. Operative blood loss was carefully measured. RESULTS Although the administration of DDAVP decreased overall blood loss by an average of 19% compared with blood loss in the placebo group and blood loss per vertebra fused by an average of 15%, these results were not statistically significant. CONCLUSIONS Bleeding time and blood loss seem to respond better to DDAVP in some patients, in whom significant decreases were observed, than they do in others. The problem is in identifying those patients in whom a decrease in bleeding time will be elicited after administration of DDAVP. Preoperative administration of DDAVP to such patients should significantly decrease operative blood loss.
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A study of desmopressin and blood loss during spinal fusion for neuromuscular scoliosis: a randomized, controlled, double-blinded study
Theroux MC, Corddry DH, Tietz AE, Miller F, Peoples JD, Kettrick RG
Anesthesiology. 1997;87((2):):260-7.
Abstract
BACKGROUND Studies examining the use of desmopressin acetate (DDAVP) have shown variable results in DDAVP's efficacy for reducing blood loss. Studies of adults having cardiac surgery and of children having spinal fusion have suggested that patients with complicated medical histories and complex surgical procedures may benefit from use of DDAVP. Therefore, this study was designed to examine the homeostatic effects of DDAVP in children with severe cerebral palsy undergoing spinal fusion. METHODS A randomized, double-blinded, and placebo-controlled trial of DDAVP was designed to enroll 40 patients. However, termination of the study was advised by the Institutional Review Board after 21 patients were enrolled. All patients had spastic quadriplegic-type cerebral palsy and were randomly assigned to one of two groups. The DDAVP group received 0.3 microg/kg DDAVP in 100 ml normal saline, and the placebo group received normal saline alone. All patients were anesthetized with nitrous oxide, oxygen, isoflurane, and fentanyl. Factor VIIIC and von Willebrand's factor (vWF) concentrations were measured in blood drawn before DDAVP infusion and 1 h after infusion. Blood pressure was maintained at a systolic pressure of less than 100 mmHg. Use of crystalloids, packed erythrocytes, platelets, and fresh frozen plasma were based on criteria established by protocol. Estimated blood loss was assessed by weighing sponges and measuring suctioned blood from canisters. RESULTS Estimated blood loss (intraoperative and postoperative) and amount of packed erythrocytes transfused were similar for the DDAVP and placebo groups. Concentrations of both factor VIIIC and vWF were significantly greater after DDAVP infusion when compared with concentrations after placebo infusion. CONCLUSIONS In the children who had complex spinal fusion, there was no difference in estimated blood loss between those who received DDAVP and those who received a placebo. Administration of DDAVP significantly increased factor VIIIC and vWF levels.