-
1.
The effect of injection of epinephrine 1:100,00 solution in pterygopalatine fossa on intraoperative bleeding during endoscopic sinonasal surgeries in chronic sinusitis: a blinded clinical trial
Nasirmohtaram, S., Jalali, M., Faghih Habibi, A., Akbarpour, M.
The Journal of laryngology and otology. 2024;:1-11
-
2.
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.
-
3.
Comparative Study of Bipolar Electrocautery Versus Silk Ligation for Hemostasis During Tonsillectomy
Bashir, S., Swami, G.
Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India. 2023;75(3):2025-2028
Abstract
Tonsillectomy is a commonly performed surgery in otolaryngological practice. Owing to the possibility of postoperative bleeding, it is considered as one of the major surgical procedures. Various techniques have been advocated, however dissection and electrocautery are the most commonly used techniques in tonsillectomy. The objective was to study and compare the relative efficacy using two methods of tonsillectomy- bipolar electrocautery versus silk ligation. This prospective study included 50 patients who underwent tonsillectomy. Patients were randomly divided into two groups. In Group A, left tonsillar fossa haemorrhage was controlled by ligation, while in Group B, bipolar diathermy was used to control bleeding of right tonsillar fossa. Comparison was done in terms of time taken for hemostasis, amount of intra-operative blood loss and post-operative pain. 130 (72.22%) male and 50 (27.77%) females were included. Group A included 20 cases while Group B included 30 cases. The mean time taken for hemostasis in Group A patients was 40.5 ± 4.4 min as compared to 25.3 ± 6.2 min in Group B patients. The mean blood loss on cautery side was 49.5 ± 4.5 ml and that on the ligation side was 68.6 ± 5.3 ml. Post-operative pain was significantly more in Group B patients as compared to Group A patients. Bipolar diathermy is a quicker and faster method to achieve hemostasis with little intraoperative blood loss as compated to silk ligation.
-
4.
Determining the Effectiveness of Fibrin Sealants in Reducing Complications in Patients Undergoing Lateral Neck Dissection (DEFeND): A Randomised External Pilot Trial
Bajwa, M. S., Jackson, R., Dhanda, J., Tudur Smith, C., Shaw, R. J., Schache, A. G.
Cancers. 2023;15(20)
Abstract
OBJECTIVES High-quality randomised controlled trials (RCT) to support the use of Fibrin Sealants (FS) in neck dissection (ND) are lacking. The DEFeND trial assessed critical pilot/feasibility questions and signals from clinical outcomes to inform a future definitive trial. PATIENTS AND METHODS The study design piloted was a blinded surgical RCT. All participants underwent unilateral ND for head and neck cancer. Interventional arm: ND with application of FS. CONTROL ARM ND alone. Feasibility outcomes included recruitment, effectiveness of blinding, protocol adherence and evaluating administrative processes. Clinical outcomes included surgical complications (primary outcome), drainage volume, time to drain removal, length of hospital stay, pain and the Neck Dissection Impairment Index. RESULTS Recruitment completed ahead of time. Fifty-three patients were recruited, and 48 were randomised at a rate of 5.3 patients/month. Blinding of patients, research nurses and outcome assessors was effective. Two protocol deviations occurred. Two patients were lost to follow-up. The mean (SD) Comprehensive Complication Index in the interventional arm was 6.5 (12.8), and it was 9.9 (14.2) in the control arm. The median (IQR) time to drain removal (days) was shorter in the interventional arm (2.67 (2.42, 3.58) vs. 3.40 (2.50, 4.27)). However, this did not translate to a clinically significant reduction in median (IQR) length of hospital stay in days (intervention: 3.48 (2.64, 4.54), control: 3.74 (3.11, 4.62)). CONCLUSION The proposed trial design was effective, and a definitive surgical trial is feasible. Whilst there was a tendency for FS to improve clinical outcomes, the effect size did not reach clinical or statistical significance. (ISRCTN99181100).
-
5.
Results of Fibrin Glue Applied Over the Corneal Surface Immediately After Pterygium Surgery: A Novel Pain Relief Technique
Feltrin de Barros, G., Susanna, B. N., Brito, L., Lima, V. L., Moscovici, B. K.
Cornea. 2023
Abstract
PURPOSE The aim of this study was to compare the use of fibrin glue on the corneal epitheliectomy site at the end of pterygium surgery versus conventional eye patch regarding pain levels, need for oral analgesic medications, number of days feeling pain, and awakening due to pain after surgery. METHODS Forty-eight eyes of 24 patients with bilateral primary pterygium were included in this prospective, randomized, double-masked controlled trial. Each eye of the same patient was randomized to the intervention or control group. The intervention group received 2 drops of fibrin glue in the epitheliectomy site at the end of surgery and an eye patch, whereas the control group was only received an eye patch. Patients returned on the first and seventh days after surgery. Pain intensity (measured using the visual pain analog scale), need for oral analgesics, the number of days the pain lasted, and quality of sleep were assessed during follow-up visits and compared between groups. Comparison analysis accounted for sex, age, pterygium grading, and comorbidities. RESULTS Visual analog pain scale after surgery was significantly lower in eyes receiving fibrin glue (-1.58; 95% confidence interval: -2.84 to -0.32; P = 0.014). In addition, the intervention group presented a 73% lower chance of using oral analgesics (OR: 0.27; 95% confidence interval: 0.07-0.95; P = 0.041). No difference in the awakenings at night was noted (P = 0.240) nor the mean days of ocular pain in the first week after surgery (P = 0.474). CONCLUSIONS Fibrin glue at the end of pterygium surgery effectively reduces pain and the need for oral analgesics compared with conventional eye patching. This study is the first to describe the results of this strategy.
-
6.
Tranexamic acid does not significantly lower postoperative bleeding after endoscopic sinus and nasal surgery
Khanwalkar A, Chan E, Roozdar P, Kim D, Ma Y, Hwang PH, Nayak JV, Patel ZM
International forum of allergy & rhinology. 2023
Abstract
BACKGROUND Postoperative epistaxis is a known possibility following endoscopic sinonasal surgery. Tranexamic acid (TXA) has been shown to reduce intraoperative blood loss and improve the visual field. This study evaluates the clinical efficacy of TXA when given at end of surgery to reduce postoperative bleeding. METHODS This randomized, double-blinded placebo-controlled trial was conducted from April to November 2021. Patients scheduled to undergo endoscopic sinus or nasal surgery were randomized to receive an intravenous dose of 1g TXA or saline intraoperatively prior to extubation. A 10-inch visual analog scale (VAS) was used to query patients regarding postoperative bleeding each day for one week. The medical record was examined to determine the need for additional evaluations or interventions for epistaxis. RESULTS 40 patients completed the study. The mean/SD postoperative bleeding VAS for the TXA group on the day of surgery was not significantly different from the saline group (4.82 [2.18] in vs 5.03 [2.14] in, p = 0.8). There were no significant differences between treatment arms on any postoperative day through day 7 (0.67 [1.84] in vs 0.87 [0.99] in, p = 0.7), nor in the reduction in VAS compared to the respective baseline on the day of surgery. There were no significant differences in terms of additional interventions (e.g. additional evaluation in recovery, ED, or clinic, need for packing, or return to OR). CONCLUSION While TXA has previously demonstrated efficacy to reduce intraoperative bleeding during sinonasal surgery, when postoperative bleeding is already minimal at baseline, TXA does not appear to reduce it significantly further. This article is protected by copyright. All rights reserved.
-
7.
Leukocyte- and platelet-rich fibrin in endoscopic endonasal skull base reconstruction: study protocol for a multicenter prospective, parallel-group, single-blinded randomized controlled non-inferiority trial
Coucke, B., Van Hoylandt, A., Jorissen, M., Meulemans, J., Decramer, T., van Loon, J., Vander Poorten, V., Theys, T., Van Gerven, L.
Trials. 2023;24(1):488
Abstract
BACKGROUND Recent advances in endoscopic endonasal transsphenoidal approaches (EETA) for skull base lesions have resulted in a significant increase in extent and complexity of skull base defects, demanding more elaborate and novel reconstruction techniques to prevent cerebrospinal fluid (CSF) leakage and to improve healing. Currently, commercially available fibrin sealants are often used to reinforce the skull base reconstruction. However, problems have been reported regarding hypersensitivity reactions, efficacy, and costs. This trial aims to investigate autologous leukocyte- and platelet-rich fibrin (L-PRF) membranes as an alternative for commercially available fibrin glues in EETA-related skull base reconstruction reinforcement. METHODS/DESIGN This multicenter, prospective randomized controlled trial aims to demonstrate non-inferiority of L-PRF membranes compared to commercially available fibrin sealants in EETA cases (1) without intra-operative CSF-leak as dural or sellar floor closure reinforcement and (2) in EETA cases with intra-operative CSF-leak (or very large defects) in which a classic multilayer reconstruction has been made, as an additional sealing. The trial includes patients undergoing EETA in three different centers in Belgium. Patients are randomized in a 1:1 fashion comparing L-PRF with commercially available fibrin sealants. The primary endpoint is postoperative CSF leakage. Secondary endpoints are identification of risk factors for reconstruction failure, assessment of rhinological symptoms, and interference with postoperative imaging. Additionally, a cost-effectiveness analysis is performed. DISCUSSION With this trial, we will evaluate the safety and efficacy of L-PRF compared to commercially available fibrin sealants. TRIAL REGISTRATION ClinicalTrials.gov NCT03910374. Registered on 10 April 2019.
-
8.
Evaluation of the Efficacy of Magnesium Sulfate in Reducing Blood Loss in Functional Endoscopic Sinus Surgery: A Randomized Double-Blinded Controlled Trial
Preethi, A., Venkatraman, R., Karthika, U., Rangapriya, A.
Cureus. 2023;15(5):e38636
Abstract
Objectives The primary concern in functional endoscopic sinus surgery (FESS) is maintaining a clear and unobstructed surgical field. Achieving this objective necessitates controlled hypotension, which can aid in the surgical dissection process and reduce the overall duration of the operation. This study aims to evaluate the efficacy of a sole bolus injection of intravenous magnesium sulfate in FESS. The outcomes measured include blood loss, surgical field grading, the additional intraoperative requirement of fentanyl, stress attenuation during laryngoscopy and endotracheal intubation, and extubation time. Methods In this prospective, double-blinded, randomized control trial (CTRI/2021/04/033052), 50 patients scheduled for FESS were randomly divided into two groups: Group M received 50 mg/kg MgSO(4) in 100 ml normal saline, and Group N received 100 ml plain normal saline 15 min before induction. The study assessed total blood loss, measured by blood collected from the surgical field and weighing gauze. The surgical field grading was assessed by a six-point Fromme and Boezaart scale. We also observed stress attenuation during laryngoscopy and endotracheal intubation, additional intraoperative fentanyl requirements, and time taken for extubation. The sample size was estimated using the G power calculator 3.1.9.2 (http://www.gpower.hhu.de/). Data were entered in Microsoft Excel (Microsoft Corporation, Redmond, WA) and analyzed using Statistical Package for Social Sciences version 20.0 (IBM Corp., Armonk, NY). Results The demographic data and duration of the surgery were comparable in both groups. The total blood loss in Group M was 100.40 ml ±60.71 ml, which is lower than Group N (133.80 ml ±59.7 ml) with a p-value of 0.016. In addition, the surgical field grading was also better in Group M. The total vecuronium consumption was significantly lower in Group M, which was (7.23±0.84 mg); in Group N, it was (10.64±1.74 mg) with a p-value of 0.0001, respectively. The dosage of additional fentanyl in Group N was 38.46 mcg ± 8.99 mcg, more than in Group M (33.64 mcg ± 11.20 mcg). The time required for extubation was similar in both groups. The duration of the surgery was significantly more significant in Group M (150.0 ±31.36) than in Group N (205.0 ±32.79), with a p-value of 0.0001, respectively. Furthermore, the mean arterial pressure after induction, at 2 min and 4 min after laryngoscopy, was less in Group M, with p=0.001, p=0.003, and p<0.0001, respectively, when compared with Group N. The heart rate after induction, at 2 min and 4 min after laryngoscopy, was also less in Group M, with p=0.016, p=0.003, and p=0.003, respectively, when compared with Group N. The Ramsay Sedation Score was higher in Group M than in Group N's fourth, eighth, and sixteenth hour, with p=0.001, p=0.021, and p=0.001, respectively, in the postoperative period. The sedation score was statistically insignificant after that. No complications were encountered during the study. Conclusion We conclude that a single bolus dose of MgSO(4) reduced surgical blood loss more effectively than in the control group. The surgical field grading was also better in Group M, as was the stress attenuation during laryngoscopy and endotracheal intubation. The intraoperative fentanyl requirement was not statistically significant. The time for extubation was similar between the groups. No other adverse effects were encountered during the study.
-
9.
The Effect of Chitohem Bleeding Inhibitor Powder on Pain and Bleeding After Tonsillectomy by Suturing Method
Seied-Mohammad Doulabi, S. R., Moradi, A., Roozbahany, N. A., Rezaei, S., Khoshfetrat, N., Shamsian, F., Baghi, M.
Craniomaxillofacial trauma & reconstruction. 2023;16(3):205-210
Abstract
Study Design and Objectives: This study aimed to investigate Triamcinolone ointment's effect on pain and bleeding after tonsillectomy by suturing method. Methods: The present study was performed as a single-blind clinical trial on 200 patients who underwent a total tonsillectomy in the ENT department of Loghman Hakim Hospital in Tehran during 2016. Candidates for total tonsillectomy were randomized into 2 groups one by one. Participants were randomly divided into 2 groups. Both groups matched homologically. Patients in both groups (intervention and control) underwent cold dissection total tonsillectomy. In addition to suturing, in the intervention group, Triamcinolone ointment was used to control the local bleeding at the surgical site. In the control group, only sutures were used to control bleeding. The studied variables included: bleeding and pain 24 hours after surgery, Time to start oral feeding. Result: The frequency of bleeding cases in the first 24 hours are included: 4 patients (5.63%) in the intervention group and 6 patients (8.45%) in the control group (P = 0.01). The average time to start eating for patients who were treated with topical triamcinolone ointment was significantly less than those who were not treated with this ointment. Only 2 patients (2.77%) in the intervention group took analgesics in the first 24 hours after surgery, while and 11 patients (15.3%) in the control group received analgesics in the same time period. Conclusion: In general, the results of this study showed that the use of Triamcinolone ointment in total tonsillectomy could reduce bleeding, analgesics usage, and the time of feeding onset.
-
10.
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.