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1.
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.
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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.
Impact of titanium-prepared platelet-rich fibrin in type 1 fascia graft tympanoplasty on graft survival and hearing outcomes
Yavuz, R., Arslan, S., Imamoglu, M., Isik, A. U., Bahadir, O., Y. Cobanoglu HB, Yavuz, H. B.
Nigerian journal of clinical practice. 2023;26(7):921-927
Abstract
BACKGROUND Type 1 fascia graft tympanoplasty (T1FGT) is the mainstay surgical approach for the treatment of tympanic membrane perforations. The most widely used graft material is temporal muscle fascia, and graft take rates are reported differently. The methods to enhance graft take are still being investigated. Aim: The aim of our study was to investigate the effect of titanium-prepared platelet-rich fibrin (T-PRF) on graft take and hearing outcomes in T1FGT. MATERIALS AND METHODS Fifty-seven ears eligible for T1FGT were involved in the study and prospectively evaluated. T-PRF was applied with T1FGT in 27 ears. Thirty ears in the other group underwent only T1FGT. The patients underwent an otomicroscopic and audiometric examination in preoperative and postoperative 2(nd) week, 1(st) month, and 6(th) month. Both groups were evaluated in terms of hearing levels, infection, and graft take rates. RESULTS Two patients in the T1FGT + T-PRF group and seven patients in the T1FGT group had postoperative perforation (graft take rate: 92.6% versus 76.7%). The graft take rate was found to be increased in the T-PRF group although the difference was not statistically significant. In the T1FGT group, the percentage of infection was higher than in the T1FGT + T-PRF group. When the preoperative and postoperative 6(th)-month audiometry was compared, a statistically significant hearing gain was obtained for both groups. CONCLUSION In the treatment of tympanic membrane perforations, T-PRF applied over the fascia graft was shown to increase graft take rates and decrease the probability of infection. Further studies with larger samples are needed to demonstrate the effects of PRF.
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4.
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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5.
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).
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6.
Efficacy of Continuous Suctioning in Adenoidectomy Haemostasis-Clinical Study
Epure, V., Hainarosie, R., Gheorghe, D. C.
Medicina (Kaunas, Lithuania). 2023;59(9)
Abstract
Introduction: Adenoidectomy is often the first major surgical challenge for the child's haemostatic system, and controlling intraoperative bleeding can be a challenge for the surgeon. Different methods have been used intraoperatively by surgeons in order to enhance haemostasis. The cold air effect (continuous suctioning) has been used by some surgeons during adenoidectomy; however, no documentation of its haemostatic effect has been made. Objectives: Our prospective randomised controlled study enrolled a sample of 140 children undergoing adenoidectomy, and we studied the effect of continuous suctioning on the duration of haemostasis in paediatric adenoidectomy. Materials and Methods: We evaluated the effect of using continuous suctioning during haemostasis at the end of adenoidectomy procedures, comparing variables such as total surgery time, total haemostasis time, and intraoperative blood loss, between two groups: 70 adenoidectomy procedures where no continuous suctioning was used to enhance haemostasis versus the other 70 patients where continuous suctioning was the haemostatic method employed. RESULTS After statistical analysis of the recorded data, we found that the total duration of adenoidectomy, the duration of haemostasis in adenoidectomy, and the intraoperative blood loss were significantly lower in patients in whom cold air was used for haemostasis. Intraoperative haemostasis failure (and consequent use of electrocautery for haemostasis) was more frequent in patients in whom no suctioning was used; as for the rates of postoperative primary bleeding after adenoidectomy, they were similar in both groups of patients, regardless of the technique used for haemostasis. Conclusions: The use of continuous suctioning during adenoidectomy haemostasis significantly shortens total surgical and haemostasis time, reduces intraoperative blood loss, and reduces the incidence of haemostasis failure (with the consequent need for bipolar electrocautery haemostasis).
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7.
Investigation of the effects of intranasal desmopressin on the bleeding of the patients during open septorhinoplasty: A randomized double-blind clinical trial
Akbarpour, M., Jalali, M. M., Akbari, M., Nasirmohtaram, S., Haddadi, S., Habibi, A. F., Azad, F.
Heliyon. 2023;9(7):e17855
Abstract
OBJECTIVES Rhinoplasty is one of the most common cosmetic surgeries in the world. Lack of adequate local homeostasis may lead to excessive bleeding during the operation, which increases the time of operation and recovery period, and the prevalence of complications. This study investigated the effects of nasal desmopressin on the quality of the surgical field and the volume of bleeding during rhinoplasty. MATERIALS AND METHODS This double-blind randomized clinical trial was performed on 120 patients aged 18-40 years who were candidates for rhinoplasty. Patients were randomly divided into three groups: low-dose desmopressin group and high-dose desmopressin group and placebo group. Hemodynamic changes and surgical field based on BOEZAART criteria, and the volume of bleeding were calculated. RESULTS In this study 115 women (95.8%) and 5 men (4.2%) participated. The mean age of patients was (27 ± 6.8). Bleeding volume in high dose desmopressin group was (21.7 cc ± 12.3), (27.7 cc ± 12.3) in low dose group, and (38.3 cc ± 12.3) in the placebo group, The difference in blood volume among the three groups was statistically significant with p < 0.005. Clean surgical field according to BOEZAART classification was marginally significant in both desmopressin groups. The differences in blood pressure, heart rate, blood and urine sodium, and hemoglobin before and after surgery between groups there not statistically significant. CONCLUSION Based on the results of the present study topical nasal spray desmopressin can reduce surgical field bleeding during rhinoplasty. To generalize the results to other surgeries in the ENT field it is recommended to conduct studies.
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8.
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.
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9.
The use of fibrin glue in pterygium surgery with amniotic membrane transplantation: Systematic review and meta-analysis
Karam, M., Alsaif, A., Aldubaikhi, A., Aljebreen, M., Alazaz, R., Almudhaiyan, T., AlBaghli, A.
Saudi journal of ophthalmology : official journal of the Saudi Ophthalmological Society. 2023;37(2):83-89
Abstract
PURPOSE To compare the outcomes of fibrin glue versus sutures in pterygium surgery with amniotic membrane transplantation. METHODS A systematic review and meta-analysis were performed as per the Preferred Reporting Items for Systematic Reviews and Meta-analyses Guidelines. An electronic search identified all studies comparing the outcomes of using fibrin glue versus sutures in pterygium surgery with amniotic membrane transplantation. Conjunctival inflammation, postoperative pain and discomfort, pterygium recurrence, pyogenic granuloma, and surgical time were primary outcome measures. Secondary outcome measures included amniotic membrane transplant outcomes, time to recurrence, graft loss, and subconjunctival hemorrhage. Fixed and random-effects models were used for the analysis. RESULTS Four studies enrolling 180 patients were identified. Conjunctival inflammation (odds ratio [OR] 0.21, P = 0.0005) demonstrated a significant difference favoring the fibrin glue group. Despite the trend favoring the use of fibrin glue, there were no significant differences in terms of postoperative pain and discomfort (OR = 0.46, P = 0.25), pterygium recurrence (OR = 0.74, P = 0.48), pyogenic granuloma (OR = 0.47, P = 0.38), and surgical time (mean difference = -17.52, P = 0.13). For secondary outcomes, fibrin glue had significantly fewer cases of graft loss compared with sutures. No statistically significant difference was found in amniotic membrane graft outcomes, time to recurrence, and subconjunctival hemorrhage. CONCLUSION Fibrin glue is comparable to the sutures used in pterygium surgery with amniotic membrane transplantation as it significantly improves conjunctival inflammation and does not increase postoperative pain and discomfort, pterygium recurrence, pyogenic granuloma, and surgical time.
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10.
Surgiflo® hemostatic matrix versus NasoPore® nasal packing following postassium titanyl phosphate laser surgery for hereditary hemorrhagic telangiectasia: A randomized controlled trial
Pyne JM, Murray S, Kelly BC, Song JS, Rosvall BR, Côté DWJ
Laryngoscope investigative otolaryngology. 2023;8(2):328-334
Abstract
BACKGROUND To help ensure adequate hemostasis immediately following potassium titanyl phosphate (KTP) laser treatment, many centres treating hereditary hemorrhagic telangiectasia (HHT) routinely use nasal packing post-operatively. The purpose of this study was to compare hemostatic thrombin matrix with standard packing for postoperative bleeding, patient pain, and comfort. METHODS A prospective, randomized, double-blinded, non-inferiority study was conducted with participants at an HHT centre of excellence (COE) and randomized to the treatment group with reconstituted thrombin gelatin matrix (Surgiflo®) or control group with a biodegradable synthetic polyurethane foam (NasoPore®). Adult subjects with confirmed HHT and moderate to severe epistaxis (a minimum calculated epistaxis severity score [ESS] of 4.0) warranting KTP laser treatment were recruited. Data was collected 2 weeks post operatively by a blinded reviewer completing a visual outcomes evaluation and each patient completing a subjective symptoms questionnaire. Non-parametric statistical analysis was employed. RESULTS Twenty-eight adult patients were randomized to the treatment and control arms with comparable preoperative epistaxis severity scores. Postoperative nasal bleeding was equivalent. Significantly less pain was found in the treatment arm (p = .005). While there were trends towards less obstruction and increased satisfaction in the treatment group as well as less crusting in the control group, these findings were not statistically significant. Allocation to the treatment group was associated with an approximately $75 higher cost. CONCLUSIONS When compared to NasoPore® for hemostasis, Surgiflo® hemostatic matrix performed equivalently while causing less discomfort in HHT patients following nasal KTP treatment. LEVEL OF EVIDENCE 1b.