Effectiveness and Adverse Effects of Tranexamic Acid in Bleeding during Adenotonsillectomy: A Randomized, Controlled, Double-blind Clinical Trial
International archives of otorhinolaryngology. 2021;25(4):e557-e562
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.
The effect of intranasal irrigation with epinephrine solution on intraoperative visualization and bleeding during FESS
European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery. 2021
PURPOSE Bleeding during Functional endoscopic sinus surgery (FESS) can have adverse effect on surgical outcomes. This study evaluates if there is any benefit of adding epinephrine to the saline nasal irrigation in patients undergoing elective FESS for chronic rhinosinusitis. METHODS A prospective, randomized, double-blinded study was performed. Fifty ASA I or II patients undergoing FESS were randomized to have irrigation either with normal saline or (1:100,000) epinephrine in normal saline during surgery. Outcomes measure included the Boezaart grading scale to assess the intraoperative surgical field, surgeon's satisfaction with field visualization and bleeding which was evaluated in a 10 cm visual analog scale, estimated blood loss as well as hemodynamic parameters changes. RESULTS There was no statistically significant difference in the studied variables between both groups. However in patients with higher than 12 Lund-Mackay score the volume of blood loss was significantly less in the epinephrine group. All surgical procedures were completed and there were no operative complications or any reported perioperative cardiovascular events. CONCLUSIONS Intraoperative irrigation with saline-epinephrine solution at a concentration of (1:100,000) is safe and does not change heart rate or blood pressure but is unlikely to improve the setting of intraoperative surgical field except for decreasing the volume of blood loss in patients with high Lund-Mackay score.
Desmopressin nasal spray reduces blood loss and improves the quality of the surgical field during functional endoscopic sinus surgery
Journal of anaesthesiology, clinical pharmacology. 2021;37(2):261-265
BACKGROUND AND AIMS Making a dry surgical field during functional endoscopic sinus surgery (FESS) is a challenge for anesthetists. This study was conducted to evaluate the pre-emptive hemostatic effects of a single dose of an intranasal spray of desmopressin (DDAVP) in sinus surgery. MATERIAL AND METHODS Sixty consecutive patient's as first-time candidates for FESS due to chronic sinusitis were enrolled. They were randomly allocated to receive either a nasal spray of DDAVP 20 μg or sterile water before induction of anesthesia. Management of anesthesia was achieved with propofol and remifentanil infusions. Blood loss, quality of the surgical field, and surgeon's satisfaction were compared between the two groups. RESULTS Blood loss in the DDAVP group was 147 ± 43 mL and in the placebo group 212 ± 64 mL (mean ± SD, P < 0.01). The quality of the surgical field in the DDAVP group was better than the placebo group. (median score, 1 (1-2) vs. 2 (1-3), P = 0.017). Surgeons were more satisfied with the surgical field in the DDAVP group than in the control group (median score, 4 (2.8-5) vs. 3 (2-3), P = 0.04). CONCLUSION Premedication with nasal spray DDAVP 20 μg effectively reduces bleeding and improves the surgical field during FESS.
Desmopressin effects on bleeding during functional endoscopic sinus surgery on patients with chronic rhinosinusitis
American journal of otolaryngology. 2021;42(5):103024
OBJECTIVE In this study we aimed to determine whether Desmopressin (DDAVP) can alter bleeding and improves surgeon visual field and decrease operation time or lessen use of anesthesiology medication in a clinical trial study. METHOD This study is a randomized clinical trial using the permuted block randomization method. 44 patients were enrolled in study and divided into two equal intervention-control groups. The intervention group received maximum dose of 0/2 micrograms per kg of DDAVP. In the control group, 30 min before the surgery, 100 ml of normal saline will be injected. RESULTS The amount of bleeding was 517/17 cc in control group during surgery while it was 387/72 cc in group receiving DDAVP which is significantly lower. The satisfaction of surgeon regarding suitable visual field was 6/45 in control group while it was 3/77 in DDAVP receivers which is lower. CONCLUSION It seems that intravenous DDAVP can reduce bleeding during surgery and offer an enhanced vision for surgeon during surgery but it has no potential efficacy on reduction of period of surgery and need for anesthesiology medication like remifentanil and isoflurane.
Therapeutic Efficacy of Autologous Platelet Concentrate Injection on Macular Holes with High Myopia, Large Macular Holes, or Recurrent Macular Holes: A Multicenter Randomized Controlled Trial
Journal of clinical medicine. 2021;10(12)
We aimed to evaluate the anatomical and functional outcomes of pars-plana vitrectomy (PPV) with or without autologous platelet concentrate (APC) injection in patients with recurrent macular holes (MHs), large MHs, or MHs with high myopia. This multicenter, prospective, interventional randomized controlled trial was conducted from March 2017 to April 2020. Participants were randomly allocated to a PPV group or a PPV+APC group. All participants underwent standard 25-gauge PPV, and eyes in the PPV+APC group underwent PPV with intravitreal APC injection before air-gas exchange. A total of 117 patients were enrolled (PPV group: n = 59, PPV+APC group: n = 58). Hole closure was achieved in 47 participants (79.7%) in the PPV group and 52 participants (89.7%) in the PPV+APC group. There were no between-group differences in the anatomical closure rate or functional outcomes including best-corrected visual acuity, metamorphopsia, pattern-reversal visual evoked potential, or Visual Function Questionnaire-25 score. The use of APC injection does not improve the anatomical and functional outcomes of surgery for large MHs, recurrent MHs, or MHs with high myopia. The adjunctive use of APC can be considered in selected cases because it is not inferior to conventional MH surgery, is relatively simple to perform, and is not affected by the surgeon's skill.
Combination of a negative pressure suction device and endoscope can accurately locate the bleeding site of refractory epistaxis
Acta oto-laryngologica. 2021;:1-5
BACKGROUND Selective endoscopic coagulation of a nasal bleeding vessel is an effective means of treating epistaxis. Precisely locating the bleeding site(s) is critical. OBJECTIVE To investigate the utility of combining a negative pressure suction device and endoscope in locating bleeding sites of refractory epistaxis. METHODS A total of 116 patients with refractory epistaxis, who underwent systematic endoscopic exploration under local anesthesia in the absence of identifiable sites of bleeding were randomizely divided into two groups via negative pressure group (NPG) and control group (CG): The negative pressure suction device combined with an endoscope was used to re-explore the epistaxis. Nasal bleeding was induced using this method to help the operator locate the site of epistaxis accurately; the bleeding was then stopped using electrocoagulation with the suction electrode. The CG was treated with endoscopic re-exploration and selective tamponade. RESULTS Compared with the CG, there were statistically significant differences in length of hospital stay, rebleeding, and postoperative pain and complications (all p < .05). CONCLUSION AND SIGNIFICANCE Combining a negative pressure suction device and endoscope was a safe and effective technique for accurately locating bleeding sites in patients with refractory epistaxis.
Intravitreal bevacizumab (IVB) versus IVB in combination with pars plana vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy: a randomized clinical trial
International journal of retina and vitreous. 2021;7(1):35
BACKGROUND The main purpose of this study is to compare the vitreous hemorrhage (VH) score reduction and visual acuity outcomes in patients with VH secondary to proliferative diabetic retinopathy (PDR) treated with intravitreal injections of bevacizumab (IVB) versus IVB and pars plana vitrectomy (IVB and PPV). METHODS Patients with VH secondary to PDR were randomized into 2 groups: in Group A, patients were treated with a total of 3 IVB (1.5 mg/0.06 ml) at 8-week intervals; and in Group B, patients received a single IVB (1.5 mg/0.06 ml) and, 7 days later, underwent PPV. Patients received an ophthalmic evaluation that included best-corrected visual acuity (BCVA), indirect ophthalmoscopy, and mode B echography at weeks 8, 16 and 24. VH was classified according to the Diabetic Retinopathy Vitrectomy Study classification as grade 1, 2 or 3. Change in VH score was the primary outcome measure and change in BCVA was the secondary outcome. RESULTS Seventy-three eyes of 66 patients were randomized and 70 eyes completed the 24-week follow-up visit. Mean VH score reduction (± SEM) of 0.4571 ± 0.0283 (p = 0.0014), 1.3429 ± 0.0393 (p < 0.0001) and 1.8286 ± 0.0438 (p < 0.001) was observed in Group A at 8, 16 and 24 weeks after treatment, respectively (Table 2; Fig. 2). In Group B, the reduction of VH score (± SEM) was 2.2571 ± 0.0720 (p = 0.0014), 2.2857 ± 0.0606 (p < 0.0001) and 2.2286 ± 0.0726 (p < 0.001) at 8, 16 and 24 weeks after treatment, respectively. Group comparison revealed a significantly greater reduction in mean VH score in Group B at 8 and 16 weeks after treatment (p < 0.0001). However, at 24 weeks this difference was no longer statistically significant (p = 0.1854). In Group A, mean (± SEM) BCVA showed an improvement of 0.00285 ± 0.0004 (p = 0.971), 0.5371 ± 0.0072 (p < 0.0001), 0.8143 ± 0.0001 (p < 0.0001) and 0.8543 ± 0.0008 (p < 0.0001) compared to baseline at 1, 8, 16 and 24 weeks after treatment, respectively. In Group B, mean (± SEM) BCVA showed an improvement of 0.3657 ± 0.0507 (p = 0.0002), 0.8857 ± 0.0385 (p < 0.0001), 0.9457 ± 0.0499 (p < 0.0001) and 0.9629 ± 0477 (p < 0.0001) compared to baseline at 1, 8, 16 and 24 weeks after treatment, respectively. No significant difference in BCVA improvement was observed between groups at 24 weeks after treatment. CONCLUSION PPV with preoperative IVB is associated with more rapid clearance of VH and improvement in BCVA than IVB injections alone. However, after 24 weeks of follow-up, the reduction in VH score and BCVA were similar between both treatment strategies. Trial Registration The project is registered in Plataforma Brasil with CAAE number 927354.7.0000.5440 and was approved by the Ethics Committee of the Clinics Hospital of Ribeirao Preto Medicine School of São Paulo University-Ribeirão Preto, São Paulo, Brazil (appreciation number 3.053.397 gave the approval).
Dexmedetomidine decreased the post-thyroidectomy bleeding by reducing cough and emergence agitation - a randomized, double-blind, controlled study
BMC anesthesiology. 2021;21(1):113
BACKGROUND Bleeding after thyroidectomy occurs due to violent coughing during emergence. Dexmedetomidine is helpful for the smooth emergence and suppression of cough. The purpose of the present study was to compare the effects of dexmedetomidine on postoperative bleeding after thyroidectomy. METHODS Randomized, double-blind, controlled trials were conducted in female patients (ASA I-II, aged 20 to 60 years). The patients were randomly allocated into two groups. Approximately 15 min before the end of the surgery, dexmedetomidine was administered (0.6 µg/kg/h) without a loading dose in group D (n = 69), and normal saline was administered in group S (n = 70) at the same infusion rate. Hemodynamic data, coughing reflex, extubation time, Ramsay sedation scale (RSS), and recovery time were assessed during the administration of the study drugs and recovery from anesthesia. The amount of postoperative hemorrhage was measured for 3 days. RESULTS Data from a total of 139 patients were analyzed. The incidence of severe cough was significantly lower in group D than in group S (4.3 % vs. 11.5 %, P = 0.022). The emergence agitation in the postanesthetic care unit was significantly lower in group D than in group S (P = 0.01). Postoperative bleeding was significantly lower in group D than in group S until the second postoperative day (P = 0.015). CONCLUSIONS Dexmedetomidine can be helpful in decreasing bleeding after thyroidectomy by reducing coughing and emergence agitation. TRIAL REGISTRATION This study was registered at http://clinicaltrials.gov (registration number NCT02412150, 09/04/2015).
Autologous Platelet- and Extracellular Vesicle-Rich Plasma Is an Effective Treatment Modality for Chronic Postoperative Temporal Bone Cavity Inflammation: Randomized Controlled Clinical Trial
Frontiers in bioengineering and biotechnology. 2021;9:677541
PURPOSE To determine the efficacy of autologous platelet- and extracellular vesicle-rich plasma (PVRP) to treat chronic postoperative temporal bone cavity inflammation (CPTBCI) after exhausting surgical and standard conservative therapies. MATERIALS AND METHODS Patients were randomly allocated to treatment with PVRP (PVRP group) or standard conservative methods (control group) in a setting of four once-monthly checkups and subsequent follow-up. The treatment outcome was measured with the Chronic Otitis Media Questionnaire-12 (COMQ-12), CPTBCI focus surface area, and CPTBCI symptom-free time after the fourth checkup. RESULTS Eleven patients from each group completed the trial; 95% of patients suffered from chronically discharging mastoid cavity (the type of CPTBCI). Within four checkups, the COMQ-12 score decreased statistically significantly in the PVRP group (p < 0.001) but not in the control group (p = 0.339). The CPTBCI foci surface area decreased statistically significantly between the first and second checkups (p < 0.0005) but not between other checkups (p > 0.05) in the PVRP group. No statistically significant differences in CPTBCI foci surface area were detected between checkups in the control group (p = 0.152). Nine patients from the PVRP group and three patients from the control group were CPTBCI symptom-free at the fourth checkup. The median symptom-free time was 9.2 months (95% CI [7.4, 11.9]) in the PVRP group. Cumulatively, 49% of patients in the PVRP group remained CPTBCI symptom-free for 12.7 months after the fourth checkup. CONCLUSION Autologous PVRP represents a novel additional and successful treatment modality for a chronically discharging radical mastoid cavity when the surgical and standard conservative treatment methods have been exhausted. TRIAL NUMBER https://clinicaltrials.gov (NCT04281901).
A Clinical Study of Platelet-Rich Fibrin Combined With Autologous High-Density Fat Transplantation in Augmentation Rhinoplasty
Ear, nose, & throat journal. 2021;:1455613211016902
OBJECTIVE This study was designed to analyze the clinical effect of autologous fat-granule transplantation in augmentation rhinoplasty and explore methods to improve the fat retention rate. METHODS A total of 70 enrolled patients were randomly divided into 2 groups: the platelet-rich fibrin (PRF) combined with high-density fat transplantation group (combined group) and the conventional fat-granule transplantation group (control group; n = 35 in each group). In the combined group, an appropriate amount of autologous fat was extracted and centrifuged, and the lower layer of high-density fat was taken and mixed with PRF isolated from whole blood for autotransplantation. In the control group, only fat was extracted and centrifuged for transplantation. The patients were followed up with for more than one year to observe the short- and long-term effects, complications, safety, and patient satisfaction. RESULTS Six months after the operation, the nasal shape was stable, the contour was higher and more stereoscopic than before, the average increase of nasal height was 3.0 mm in the combined group and 2.0 mm in the control group. No complications, such as fat embolism, infection, or necrosis occurred during the 1-year follow-up. The satisfaction rate between the 2 groups has statistical significance (P < .05). CONCLUSION Overall, PRF combined with autologous high-density fat transplantation is simple to perform, has a significantly increased fat-retention rate than the control group, and has stable long-term effects without obvious adverse reactions. A sufficient amount of fat and PRF transplantation can achieve a good orthopedic effect. Thus, this method can be widely used in clinical augmentation rhinoplasty.