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1.
Comparison of Tranexamic Acid and Dexmedetomidine on Bleeding in Endoscopic Sinus Surgery
Ahmadi MS, Jahanshahi J, Hashemian F, Salimbahrani AR, Haghi N, Khanlarzadeh E
Iranian journal of otorhinolaryngology. 2023;35(126):49-56
Abstract
INTRODUCTION The quality of the surgical field during the surgery is impaired when bleeding occurs. This study compared the effect of tranexamic acid and dexmedetomidine on the rate of bleeding during endoscopic sinus surgery (ESS). MATERIALS AND METHODS In this one-blind clinical trial, 72 patients with chronic rhinosinusitis who were candidates for ESS at Be'sat Hospital in Hamedan were randomly assigned to two groups. Group A received dexmedetomidine at a dose of 1μg/kg, and group B received tranexamic acid at a dose of 10mg/kg immediately after induction of anesthesia intravenously within 15 minutes. The two groups were evaluated and compared regarding the quality of the surgery field with the Boezaart scale, volume of intraoperative bleeding, hemodynamic changes, and complications up to 90 minutes after the beginning of surgery. RESULTS The mean volume of intraoperative bleeding in group A (181.67±86.66) was significantly higher than in group B (110.28±61.23) (P =0.000). At 15, 30, and 60 minutes, the quality of the surgical field in group B was better than group A (P =0.038), while at 90 minutes, there was no statistically significant difference (P =0.450). The mean arterial pressure in group A at 15 minutes was higher than in group B (P=0.003); at 60 and 90 minutes, it was lower, and the difference was statistically significant (P =0.01). On the other hand, in 30 minutes, the mean arterial pressure in group A was higher than in group B, without a significant difference (P =0.07). Moreover, there was no statistically significant difference between the average surgery time (P = 0.25) and the frequency of complications (P =0.405). CONCLUSIONS Based on the results, tranexamic acid is preferable to injectable dexmedetomidine to control and reduce bleeding during ESS.
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2.
Topical combined tranexamic acid and epinephrine versus topical epinephrine in control of intraoperative bleeding of external dacryocystorhinostomy
Salamah, M. A., Al Bialy, H. A., Khairy, M. A., Ali, A. G.
International ophthalmology. 2023
Abstract
PURPOSE To compare the efficacy of gauze soaked with combined tranexamic acid (TXA) (100 mg/ml) epinephrine 1:200,000 versus gauze soaked with only epinephrine 1:200,000 used to guard against intraoperative bleeding in external Dacryocystorhinostomy (DCR). PATIENTS AND METHODS The study included 33 patients; only 30 patients fulfilled the inclusion criteria and were divided randomly into 2 groups using the random numbers table, with 15 patients in each group. The first group (Group A) was operated upon using gauze soaked with combined TXA (100 mg/ml) and epinephrine 1:200,000, while the second group (Group B) was operated upon using gauze soaked only with epinephrine 1:200,000. RESULTS The amount of bleeding was significantly lower in group A (29.4 ± 17.1 ml) compared to group B (49.1 ± 18.1 ml), with a P value = 0.005. In addition, the number of used gauzes and total surgical time was significantly lower in group A compared to group B, with P value = 0.008 and 0.01 respectively. CONCLUSION External DCR using gauze soaked with combined TXA (100 mg/ml) and epinephrine 1:200,000 showed a significant reduction in the amount of intraoperative bleeding compared to gauze soaked with epinephrine 1:200,000 only. The reduction in the amount of bleeding with the addition of TXA resulted in clearer surgical field, shorter surgical time and more surgeon satisfaction.Query.
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3.
Tranexamic acid for the reduction of bleeding during functional endoscopic sinus surgery
Lourijsen, E., Avdeeva, K., Gan, K. L., Pundir, V., Fokkens, W.
The Cochrane Database of Systematic Reviews. 2023;2(2):Cd012843
Abstract
BACKGROUND Chronic rhinosinusitis, with or without nasal polyps, can have a major impact on a person's quality of life. Treatment is usually conservative and may include nasal saline, intranasal corticosteroids, antibiotics or systemic corticosteroids. If these treatments fail endoscopic sinus surgery can be considered. During surgery, visibility of the surgical field is important for the identification of important anatomic landmarks and structures that contribute to safety. Impaired visualisation can lead to complications during surgery, inability to complete the operation or a longer duration of surgery. Different methods are used to decrease intraoperative bleeding, including induced hypotension, topical or systemic vasoconstrictors or total intravenous anaesthesia. Another option is tranexamic acid, an antifibrinolytic agent, which can be administered topically or intravenously. OBJECTIVES To assess the effects of peri-operative tranexamic acid versus no therapy or placebo on operative parameters in patients with chronic rhinosinusitis (with or without nasal polyps) who are undergoing functional endoscopic sinus surgery (FESS). SEARCH METHODS The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 10 February 2022. SELECTION CRITERIA Randomised controlled trials (RCTs) comparing intravenous, oral or topical tranexamic acid with no therapy or placebo in the treatment of patients (adults and children) with chronic rhinosinusitis, with or without nasal polyps, undergoing FESS. DATA COLLECTION AND ANALYSIS We used the standard methodological procedures expected by Cochrane. Primary outcome measures were surgical field bleeding score (e.g. Wormald or Boezaart grading system), intraoperative blood loss and significant adverse effects (seizures or thromboembolism within 12 weeks of surgery). Secondary outcomes were duration of surgery, incomplete surgery, surgical complications and postoperative bleeding (placing of packing or revision surgery) in the first two weeks after surgery. We performed subgroup analyses for methods of administration, different dosages, different forms of anaesthesia, use of thromboembolic prophylaxis and children versus adults. We evaluated each included study for risk of bias and used GRADE to assess the certainty of the evidence. MAIN RESULTS We included 14 studies in the review, with a total of 942 participants. Sample sizes in the included studies ranged from 10 to 170. All but two studies included adult patients (≥ 18 years). Two studies included children. Most studies had more male patients (range 46.6% to 80%). All studies were placebo-controlled and four studies had three treatment arms. Three studies investigated topical tranexamic acid; the other studies reported the use of intravenous tranexamic acid. For our primary outcome, surgical field bleeding score measured with the Boezaart or Wormald grading score, we pooled data from 13 studies. The pooled result demonstrated that tranexamic acid probably reduces the surgical field bleeding score, with a standardised mean difference (SMD) of -0.87 (95% confidence interval (CI) -1.23 to -0.51; 13 studies, 772 participants; moderate-certainty evidence). A SMD below -0.70 represents a large effect (in either direction). Tranexamic acid may result in a slight reduction in blood loss during surgery compared to placebo with a mean difference (MD) of -70.32 mL (95% CI -92.28 to -48.35 mL; 12 studies, 802 participants; low-certainty evidence). Tranexamic acid probably has little to no effect on the development of significant adverse events (seizures or thromboembolism) within 24 hours of surgery, with no events in either group and a risk difference (RD) of 0.00 (95% CI -0.02 to 0.02; 8 studies, 664 participants; moderate-certainty evidence). However, there were no studies reporting significant adverse event data with a longer duration of follow-up. Tranexamic acid probably results in little difference in the duration of surgery with a MD of -13.04 minutes (95% CI -19.27 to -6.81; 10 studies, 666 participants; moderate-certainty evidence). Tranexamic acid probably results in little to no difference in the incidence of incomplete surgery, with no events in either group and a RD of 0.00 (95% CI -0.09 to 0.09; 2 studies, 58 participants; moderate-certainty evidence) and likely results in little to no difference in surgical complications, again with no events in either group and a RD of 0.00 (95% CI -0.09 to 0.09; 2 studies, 58 participants; moderate-certainty evidence), although these numbers are too small to draw robust conclusions. Tranexamic acid may result in little to no difference in the likelihood of postoperative bleeding (placement of packing or revision surgery within three days of surgery) (RD -0.01, 95% CI -0.04 to 0.02; 6 studies, 404 participants; low-certainty evidence). There were no studies with longer follow-up. AUTHORS' CONCLUSIONS There is moderate-certainty evidence to support the beneficial value of topical or intravenous tranexamic acid during endoscopic sinus surgery with respect to surgical field bleeding score. Low- to moderate-certainty evidence suggests a slight decrease in total blood loss during surgery and duration of surgery. Whilst there is moderate-certainty evidence that tranexamic acid does not lead to more immediate significant adverse events compared to placebo, there is no evidence regarding the risk of serious adverse events more than 24 hours after surgery. There is low-certainty evidence that tranexamic acid may not change postoperative bleeding. There is not enough evidence available to draw robust conclusions about incomplete surgery or surgical complications.
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4.
Comparison of Tranexamic acid, Remifentanil, and Hydralazine on the bleeding volume during Dacryocystorhinostomy surgery
Moradi Farsani D, Shetabi H, Rafiee Zadeh A, Saffari Rad N
International journal of physiology, pathophysiology and pharmacology. 2022;14(3):177-186
Abstract
BACKGROUND Bleeding in Dacryocystorhinostomy (DRC) limits the surgeon's sight and access. Tranexamic acid, Remifentanil, and Hydralazine reduce intraoperative blood loss. However, no study has been carried out to compare the efficacy of the latter drugs during DCR surgery. METHODS Ninety healthy candidates for DCR surgery with chronic Dacryocystitis (aging 20-80) were randomly assigned in groups of 30 to receive low doses of Tranexamic acid (TXA) (10 mg/kg with a maximum dose of 1000 mg), Remifentanil (0.1 µ/kg), or Hydralazine (0.1 mg/kg). All drugs were infused over 15 minutes before the initiation of surgery. The primary outcome was the bleeding volume during the surgery and until 2 hours in recovery. This study was approved by the Iranian Registry of Clinical Trials with the code of IRCT20210614051574N10 (https://en.irct.ir/trial/62759). RESULTS Thirty patients (mean age ± SD: 50.48±13.4) were investigated. Mean blood loss volume was lower in Remifentanil and Hydralazine groups compared with the TXA group (P<0.05); there was no significant difference (P>0.05) in bleeding volume between Remifentanil and Hydralazine groups (Tranexamic acid group: 146.83±91 ml, Remifentanil group: 77.6±52.1 ml, Hydralazine group: 80.0±48.7 ml, 95% confidence interval, P<0.05). CONCLUSION Our results show that Remifentanil and Hydralazine are more effective than Tranexamic acid in bleeding control.
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5.
Comparison of the Effect of Injectable Tranexamic Acid and Inhaled Desmopressin in Controlling Bleeding and Ecchymosis in Open Rhinoplasty
Haddady-Abianeh S, Rahmati J, Delavari C, Molaei H
World journal of plastic surgery. 2022;11(3):24-27
Abstract
BACKGROUND Bleeding during rhinoplasty surgery has a negative effect on the quality of surgery; so, it is important to reduce bleeding during rhinoplasty. We aimed to evaluate the effect of injectable tranexamic acid (TXA) and nasal spray of desmopressin (DDAVP) on reduction in intraoperative bleeding and ecchymosis after open rhinoplasty. METHODS In a Randomized Clinical Trial ( RCT) prepared since 2020 to 2021 in Razi Hospital and Imam Khomeini Hospital, Tehran, Iran on 42 patients who underwent open rhinoplasty were divided into three groups. In the first group, TXA was injected one hour before surgery at a dose of 10 mg / kg with a placebo inhalation spray. In the second group, DDAVP was administered as a nasal spray at a dose of 40 mcg with a placebo injection. The third group received a placebo spray and placebo injection. All required data were gathered and analyzed. RESULTS In TXA group and DDAVP groups, the volume of bleeding during surgery significantly (P=0.022) decreased compared to placebo group, also, the quality of the surgical field and the surgeon's satisfaction significantly (P=0.007) improved compared to the placebo group but not with each other. Unlike placebo group, there were no reports of postoperative bleeding in the TXA and DDAVP groups. Duration of surgery, ecchymosis on the day after surgery and coagulation tests before and after surgery were not significantly different in three groups. CONCLUSION Use of DDAVP and TXA can both reduce the amount of bleeding during surgery and postoperative bleeding in rhinoplasty and improve the quality of the surgical field and the surgeon 's satisfaction during surgery.
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6.
Comparative study of the effect of administering two doses of tranexamic acid in patients undergoing adenotonsillectomy
Shafa A, Besharati S, Shetebi H, Shahhoseini S, Rafiee Zadeh A
International journal of physiology, pathophysiology and pharmacology. 2022;14(4):233-239
Abstract
BACKGROUND Adenotonsillectomy is a safe and common operation to remove adenoids and tonsils. Here we decided to compare the two dosages of tranexamic acid and their effects on hemodynamic changes and anesthesia-related indexes during surgical interventions. METHODS This is a double-blinded clinical trial performed in 2019-2020 on 64 children who were candidates for adenotonsillectomy. The patients were randomly divided into two groups of 32 based on the table of random numbers. Group A received 5 mg/kg slowly tranexamic acid for 10 minutes and group B received 10 mg/kg tranexamic acid slowly for 10 minutes. The study protocol was approved by the Research committee of Isfahan University of Medical Sciences and the Ethics Committee has confirmed it (Ethics code: IR.MUI.MED.REC.1398.639) (Iranian Registry of Clinical Trials (IRCT) code: IRCT20171030037093N33, https://en.irct.ir/trial/46553). RESULTS The mean volume of intraoperative bleeding in children in group A is significantly higher than in children in group B (P < 0.05). However, no significant difference was observed between the length of stay in recovery and the duration of extubation and the mean dose of propofol in the two groups (P > 0.05). The mean arterial oxygen saturation of children in both groups increased significantly over time (P < 0.05). However, no significant difference was observed between the two groups (P > 0.05). According to the results, the mean HR in both groups decreased significantly over time (P < 0.05). In addition, the mean HR in children in the group B was significantly lower than children in the group A (P < 0.05). CONCLUSION Administration of 10 mg/kg of tranexamic acid during tonsillectomy is associated with lower amounts of bleeding and lower heart rate than 5 mg/kg dosage. These results were in line with most previous studies.
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7.
A randomized control trial on the role of tranexamic acid in preventing intraoperative bleeding during external dacryocystorhinostomy
Alam, M. S., Barh, A., Kundu, D.
Indian Journal of Ophthalmology. 2022;70(10):3634-3637
Abstract
PURPOSE To evaluate the role of tranexamic acid in controlling intra-operative and immediate post-operative bleeding during external dacryocystorhinostomy. METHODS This was a double-blinded randomized placebo-controlled trial. All patients diagnosed with primary acquired nasolacrimal duct obstruction presenting between June 2018 to December 2019 were included in the study. All patients in the study group received a single dose of 1 gm tranexamic acid injection intravenously 30 minutes before the surgery, whereas the patients from group B (placebo) received normal saline. The effect of the injection was measured in terms of duration of the surgery, surgical field grading, amount of total blood loss during the surgery, and the need for postoperative nasal packing. RESULTS A total of 96 patients were included, of whom 45 were males and 51 were females. The study group (Group A) included 51 patients (27 males and 24 females) and the control group (Group B) included 45 patients (18 males and 27 females). There were no statistically significant differences between the two groups in terms of the duration of surgery (48.43 ± 20.01 minutes vs. 53.38 ± 19.8 minutes, P = 0.228), view of the surgical field (P = 0.084), the amount of intraoperative blood loss (88.63 ± 69.34 mL vs. 88.89 ± 51.93 mL, P = 0.984) and requirement of postoperative nasal packing (54.9% vs 62.2%, P = 0.471). CONCLUSION There seems to be little to justify the role of preoperative intravenous tranexamic acid injection in controlling intra-operative and immediate postoperative bleeding during external dacryocystorhinostomy.
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8.
Effectiveness and Adverse Effects of Tranexamic Acid in Bleeding during Adenotonsillectomy: A Randomized, Controlled, Double-blind Clinical Trial
Fornazieri MA, Kubo HKL, de Farias LC, da Silva AMF, Garcia ECD, Santos Gald, Pinna FR, Voegels RL
International archives of otorhinolaryngology. 2021;25(4):e557-e562
Abstract
Introduction Intra and postoperative bleeding are the most frequent and feared complications in adenotonsillectomy (AT). Tranexamic acid (TXA), which is known for its antifibrinolytic effects, has a proven benefit in reducing bleeding in hemorrhagic trauma and cardiac surgery; however, the effectiveness and timing of its application in AT have not yet been established. Objectives We aimed to evaluate the efficacy of TXA in controlling bleeding during and after AT and assess its possible adverse effects in children. Methods The present randomized, controlled, double-blind clinical trial included 63 children aged 2 to 12 years. They were randomly assigned to receive either intravenous TXA (10 mg/kg) or placebo 10 minutes before surgery. The volume of intraoperative bleeding, presence of postoperative bleeding, and adverse effects during and 8 hours after the surgery were assessed. Results No difference in bleeding volume was noted between the 2 groups (mean, 122.7 ml in the TXA group versus 115.5 ml in the placebo group, p = 0.36). No intraoperative or postoperative adverse effects were noted because of TXA use. Furthermore, no primary or secondary postoperative bleeding was observed in any of the participants. Conclusion In our pediatric sample, TXA (10 mg/kg) administration before AT was safely used, without any adverse effects. It did not reduce the bleeding volume in children during this type of surgery. Future studies should assess the use of higher doses of TXA and its administration at other time points before or during surgery.
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9.
Intravenous Tranexamic Acid Improves the Intraoperative Visualization of Endoscopic Sinus Surgery for High-Grade Chronic Rhinosinusitis: A Randomized, Controlled, Double-Blinded Prospective Trial
Yang W, Gou H, Li H, Liu Y, Wan Y, Wang C, Wang G, Zhang L
Frontiers in surgery. 2021;8:771159
Abstract
Objective: Intraoperative bleeding during endoscopic sinus surgery (ESS) for high-grade rhinosinusitis can be serious and can further obscure the surgical field. This study was designed to evaluate the effect of tranexamic acid (TXA) on the surgical visualization of ESS for high-grade rhinosinusitis. Methods: In total, 60 patients with high-grade chronic rhinosinusitis (Lund-Mackay score 12 or greater) treated by ESS were randomized into two groups: the control group (Group C) or the TXA group (Group T). Each group included 30 patients. Patients in Group T received intravenous TXA, and those in Group C received normal saline. The Boezaart grading scale (BS) score was assessed as the primary outcome. Total blood loss (TBL), whole blood coagulation, and fibrinolysis were assessed by Sonoclot analysis, and complications were recorded and compared between the groups. Result: A significant difference was found in the BS score between Group T and Group C [2.02 (1.88-2.05) vs. 2.27 (2.13-2.41), P = 0.011]. Increases in platelet function (PF) and fibrin degradation time (FDT) were assessed during the operation and showed significant differences between Group T and Group C (P = 0.040 for PF; P = 0.010 for FDT). No difference in complications was found between the two groups. Conclusion: A 15 mg/kg bolus of intravenous TXA before surgery can improve the surgical visualization of ESS for high-grade chronic rhinosinusitis without causing significant adverse effects. Intravenous TXA may be beneficial in ESS for high-grade chronic rhinosinusitis. Clinical Trial Registration: https://www.chictr.org.cn/edit.aspx?pid=121653&htm=4.
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10.
Selection of the optimal dosage of tranexamic acid to reduce blood loss during pediatric cleft palate surgery
Shafa A, Shetabi H, Adineh-Mehr L, Bahrami K
Tzu chi medical journal. 2021;33(2):181-187
Abstract
OBJECTIVE The aim of the present study was to evaluate and select the optimal dosage of tranexamic acid (TXA) to reduce blood loss during cleft palate surgery in children. MATERIALS AND METHODS This randomized double-blind clinical trial was performed on 80 children under 3 years of age that were candidates for cleft palate surgery. These children were divided into four groups as follows: the first, second, and third groups received 5, 7.5, and 10 mg/kg of TXA, respectively. Moreover, the fourth group was considered as the control group. Before induction of anesthesia and then every 15 min during the surgery, some parameters such as mean arterial pressure, heart rate, SpO(2), and ETCO(2) were recorded. Moreover, the amount of blood loss during the surgery, the level of surgeon's satisfaction, and incidence rate of complications were assessed and recorded. RESULTS The amount of blood loss during the surgery in TXA groups receiving dosages of 5, 7.5, and 10 mg/kg with the means of 63.75 ± 10.62, 61.25 ± 15.03, and 61.00 ± 14.29, respectively, was significantly lower than that of the control group with the mean of 92.25 ± 19.83 (P < 0.001). Moreover, no significant difference was found between the three groups receiving TXA dosages in terms of the amount of blood loss, the level of surgeon's satisfaction (P > 0.05). CONCLUSION According to the results of the present study, all three dosages of TXA had a significant role in reducing blood loss in cleft palate surgery. Given the potential for increased risk of side effects from the drug, it seems safe to use the minimal dosage of this drug to control and reduce blood loss during cleft palate surgery in children <3 years of age.