A randomized parallel design trial of the efficacy and safety of tranexamic acid, dexmedetomidine and nitroglycerin in controlling intraoperative bleeding and improving surgical field quality during septorhinoplasty under general anesthesia
Medical gas research. 2021;11(4):131-137
In this blinded clinical trial, we attempted to compare the efficacy and safety of administering tranexamic acid, dexmedetomidine and nitroglycerin in preventing intraoperative bleeding and improving the quality of the surgical field during septorhinoplasty under general anesthesia. A total of 105 patients scheduled for septorhinoplasty were enrolled and randomly assigned into three groups based on the balanced-block randomization method. First group received 1 μg/kg intravenous injection dexmedetomidine, second group received 10 mg/kg intravenous injection tranexamic acid and third group received 0.5 μg/kg nitroglycerin, intravenously. The study sample was composed of 105 participants with the total mean age of 25.85 ± 6.52 years, and 59.05% of participants were female and the mean of body mass index was 24.34 ± 2.57 kg/m(2). The results showed that there was no statistically significant difference in terms of arterial oxygen saturation, mean arterial pressure, heart rate, bleeding rate, duration of surgery, and surgeon satisfaction among the three groups; however, there was a significant difference in the extubation time, recovery time and the dose of administered propofol among the three groups. Dexmedetomidine reduced the dose of administered propofol while increasing the extubation time and recovery time. In the tranexamic acid group compared with the other two groups, the recovery time was shorter. However, all the three drugs could reduce intraoperative bleeding and lead to surgeon satisfaction. It can be concluded that all these three drugs can be utilized to control bleeding and improve the quality of the surgical field but the ultimate decision lies with the anesthesiologist's judgment and the conditions of the patient. The study protocol was registered in the Iranian Registry of Clinical Trials (registration No. IRCT20141209020258N121) on September 24, 2019 and it was ethically approved by the Ethical Committee of Arak University of Medical Sciences (approval No. IR.ARAKMU.REC.1397.355) on February 24, 2019.
The effect of platelet-rich fibrin (PRF) on wound healing, adhesion, and hemostasis after endoscopic sinus surgery in patients with nasal polyposis
American journal of otolaryngology. 2021;42(5):103010
PURPOSE Chronic rhinosinusitis (CRS) is one of the most common chronic diseases seen worldwide. Endoscopic sinus surgery (ESS) has become a widely accepted procedure for medically refractory chronic rhinosinusitis and nasal polyps. Prevention of revision surgery often depends on good wound healing and less adhesion formation. In recent years, the effects of platelet-rich fibrin (PRF) on tissue healing have been addressed in many surgical branches, especially for dental implant surgery and plastic surgery. METHODS This prospective study was conducted with 50 patients who underwent endoscopic sinus surgery for the diagnosis of nasal polyposis. While the middle meatus in one nasal cavity was filled with PRF and supported with Nasopore, only Nasopore was used in the other nasal cavity middle meatus. The patients were followed up clinically at weeks 1, 2, 3, 4, 8, and 12 postoperatively. The assessor determined the presence of adhesion, crusting, bleeding, frontal ostium stenosis, granulation, and infection, and if present, the grades of these complications were scored according to a questionnaire. RESULTS In our study, adhesion, infection, bleeding, granulation, and frontal ostium stenosis were less common in the PRF group, and a statistically significant difference was found between the groups. CONCLUSION In our study, better results were obtained in terms of adhesion, infection, bleeding, granulation, and frontal ostium stenosis after ESS as a result of the effects of PRF on wound healing. The application of PRF is an inexpensive and easy procedure. PRF can be a good alternative to other types of tampons after ESS.
Outcomes of combined use of topical and intravenous tranexamic acid on surgical field quality during functional endoscopic sinus surgery: A randomized controlled trial
Head & neck. 2021
BACKGROUND Intraoperative bleeding during functional endoscopic sinus surgery (FESS) poses a challenge to both surgeon and anesthetist. The primary aim of this study was to evaluate the effectiveness of local, intravenous and combined use of tranexamic acid (TA) in improving the surgical field quality during FESS. METHODS We conducted a randomized controlled double-blinded prospective trial on 120 patients scheduled for elective FESS. After induction of general anesthesia, patients were randomly and evenly assigned to one of four groups; IV TA, local TA, both IV and local TA, and placebo. Surgical field was assessed using five-point Boezaart scale. Total fentanyl and esmolol consumption, operative time, recovery time, and postoperative complications were recorded. RESULTS Surgical field quality score was the best in IV and local TA group compared to others (p < 0.001). Mean operative time was found significantly shorter in IV and local TA group than placebo one. Total fentanyl consumption was significantly lower in IV and local TA group comparing to others (p = 0.025). Mean recovery time was significantly shorter for IV and local TA group compared to others. Total fentanyl consumption was significantly lower in IV and local TA group comparing to others. No significant differences were found of mean arterial pressure and heart rate decline in four groups. None of the patients in four groups required esmolol administration. No statistically significant differences were found in change of hemoglobin, hematocrit, prothrombin time, and partial thromboplastin time over time in all groups. CONCLUSION The combined use of topical and intravenous TA provided the best surgical field in FESS, less fentanyl consumption, and less recovery time without causing significant side effects.
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.
Efficacy of topical application of autologous platelet-rich plasma in adult tonsillectomy patients: a randomised control study
The Journal of laryngology and otology. 2021;:1-6
OBJECTIVE Tonsillectomy is a painful surgery performed in cases of recurrent tonsillitis. Application of platelet-rich plasma to diminish the pain and morbidity post-tonsillectomy is gaining importance. This study evaluated post-operative pain and morbidity after autologous platelet-rich plasma application on the tonsil beds during tonsillectomy. METHOD Participants were randomised into group 1 (n = 28, peri-operative platelet-rich plasma intervention) and group 2 (n = 28, control). Post-tonsillectomy, patients were assessed (day 0, 1, 2, 3, 7 and 14) for pain, healing and time taken to return to normal activity. Data were analysed by independent t-test and chi-square test with p ≤ 0.05 as the significance level. RESULTS A significant decrease in the mean pain score up to day 7 (p < 0.05) and tonsillar fossae healing on days 2 and 3 (p < 0.05) post-tonsillectomy was noted. The majority of the patients returned to their routine activities after a week post-tonsillectomy. CONCLUSION Platelet-rich plasma application was effective in accentuating healing and reducing post-tonsillectomy pain and morbidity.
Prophylactic effect of brimonidine to minimize the incidence of subconjunctival hemorrhage in the early postoperative period after 23G pars plana vitrectomy
Therapeutic advances in ophthalmology. 2021;13:25158414211045753
BACKGROUND Several studies have investigated and demonstrated the prophylactic effect of brimonidine drops in preventing subconjunctival hemorrhage in some microincisional ophthalmic surgeries, such as intravitreal injections or cataract surgery. However, there are no previous studies investigating this prophylactic effect after 23G microincisional vitreoretinal surgery. AIM: The aim of the current study was to determine whether subconjunctival hemorrhage after 23G pars plana vitrectomy (PPV) could be prevented with the use of prophylactic topical brimonidine. METHODS This was a phase III, prospective, interventional, randomized, controlled single-center clinical trial with a follow-up of 2 weeks. A total of 77 eyes (mean age: 68.4 ± 10.7 years) undergoing 23G PPV were included and randomized into two groups: group 1 including 41 patients receiving prophylactic preoperative treatment with brimonidine, and group 2 (control group) including 36 patients not receiving this prophylactic treatment. Differences in terms of number of conjunctival quadrants affected with subconjunctival hemorrhage were evaluated in each of the follow-up visits. RESULTS The presence of subconjunctival hemorrhage was similar in both groups the first days after surgery (p > 0.05). At the last visit (10-14 days after surgery), this condition was significantly more frequent in control group where there was a significant difference, being more frequent in the control group (7.3% vs 28.6%, p = 0.022). The number of conjunctival quadrants affected was also similar in both groups, except for the last visit in which most of the patients treated with brimonidine (92.7%) showed no bleeding compared to 71.4% in control group. No effect on the efficacy of brimonidine treatment of the presence of blood hypertension, diabetes, and antiplatelet or anticoagulant treatment was observed. CONCLUSION Brimonidine seems to be a useful option to decrease subconjunctival hemorrhage after microincisional vitreoretinal surgery or improve its resolution during the first postoperative week. This finding should be mainly due to the vasoconstrictor effect of brimonidine. TRIAL REGISTRATION EudraCT, 2012-002895-15 (registered 19 December 2012); https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-002895-15.
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.
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.
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.
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.