Does tranexamic acid improve intra-operative visualisation in endoscopic ear surgery? A double-blind, randomised, controlled trial

2019 ◽  
Vol 133 (12) ◽  
pp. 1033-1037 ◽  
Author(s):  
A Das ◽  
S Mitra ◽  
D Ghosh ◽  
S Kumar ◽  
A Sengupta

AbstractObjectiveTo assess the effect of tranexamic acid on intra-operative bleeding and surgical field visualisation.MethodsFifty patients undergoing various endoscopic ear surgical procedures, including endoscopic tympanoplasty, endoscopic atticotomy or mastoidectomy, endoscopic ossiculoplasty, and endoscopic stapedotomy, were randomly assigned to: a study group that received tranexamic acid or a control group which received normal saline. The intra-operative bleeding and operative field visualisation was graded using the Das and Mitra endoscopic ear surgery bleeding and field visibility score, which was separately analysed for the external auditory canal and the middle ear.ResultsThe Das and Mitra score was better (p < 0.05) in the group that received tranexamic acid as a haemostat when working in the external auditory canal; with respect to the middle ear, no statistically significant difference was found between the two agents. Mean values for mean arterial pressure, heart rate and surgical time were comparable in both groups, with no statistically significant differences.ConclusionTranexamic acid appears to be an effective haemostat in endoscopic ear surgery, thus improving surgical field visualisation, especially during manipulation of the external auditory canal soft tissues.

2016 ◽  
Vol 21 (4) ◽  
pp. 254-260
Author(s):  
Selin Ünsaler ◽  
Bora Başaran ◽  
Şule Öztürk Sarı ◽  
Eyüp Kara ◽  
Kemal Değer ◽  
...  

Objectives: To investigate the efficacy of chitosan-dextran hydrogel (CDH) in preventing postoperative adhesions between the tympanic membrane (TM) and intratympanic structures, and to evaluate its ototoxicity in an animal study. Methods: In the first step, ototoxicity was evaluated with 7 male albino guinea pigs (GPs) via auditory brainstem responses (ABR) before and 4 weeks after unilateral intratympanic injection of CDH and saline solution contralaterally. In the second step, 12 GPs underwent bilateral ear surgery. The middle ear (ME) mucosa was abraded, and the cavity was filled with CDH on one side and packed with Gelfoam on the contralateral side. A control group of 6 GPs underwent the same procedure except that no material was applied in the ME. The animals were euthanized at the end of the 7th week, and otomicroscopic findings were noted and the temporal bones harvested for the histologic examination. The findings were scored and compared. Results: There was no statistically significant difference between the pre- and postoperative ABR thresholds. In the otomicroscopic findings, the most prominent difference between the two groups was the presence of retraction of the TM in the Gelfoam group. The histopathologic findings revealed a higher degree of inflammation in the Gelfoam group compared with the CDH group. Conclusion: This study demonstrated that CDH has no ototoxic effects in GPs. Its use as an ME packing material revealed significantly less TM retraction and inflammatory reaction compared with Gelfoam.


2020 ◽  
Vol 5 (2) ◽  
pp. 14-19
Author(s):  
Smriti Bandhu ◽  
Arunabh Mukharjee

Background: With the introduction of intentional hypotensive anesthesia in the surgical field to achieve a relatively bloodless surgical field along with the use of the operative microscope, it has revolutionized the middle ear surgery practice. Dexmedetomidine is a relatively new and potent α2 agonist prototype found efficient in rendering bloodless intra-surgical field and inducing controlled hypotension during the surgeries of the middle ear. The objective is to present prospective study was aimed at evaluating with and without dexmedetomidine infusion effect on end-tidal isoflurane concentration for lowering blood pressure by 30%, awakening time and quality of bloodless surgical field during middle ear surgical procedure. Subjects and Methods:54 patients who were to undergo middle ear surgery and had ASA I and II were randomly divided into the two groups. In Group I Dexmedetomidine was used and in Group II Normal saline. Effect of Dexmedetomidine infusion on end-tidal isoflurane concentration for lowering blood pressure by 30%, awakening time, quality of bloodless surgical field during middle ear surgical procedure, heart rate was evaluated. The data collected were statistically analyzed. Results: The mean values of the heart rate were statistically non-significant between the groups when recorded at the baseline, whereas, a statistically significant difference was seen in the values for heart rate intra-operatively. The mean values for heart rates were significantly higher for the placebo group. A significant difference in Isoflurane concentration was found with dexmedetomidine requiring a percentage of 0.6 0.4 and normal saline 1.8 0.5. Less bleeding was seen with dexmedetomidine. Conclusion:  Dexmedetomidine is a potent hypotensive agent which also reduces the requirement of Isoflurane compared  to the normal saline placebo. The use of dexmedetomidine is relatively safe and provide a relatively bloodless surgical field, hence, increasing efficacy, and improving visibility at the surgical site.


2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Luigi Canullo ◽  
Jan Friedrich Dehner ◽  
David Penarrocha ◽  
Vittorio Checchi ◽  
Annalisa Mazzoni ◽  
...  

The aim of this preliminary prospective RCT was to histologically evaluate peri-implant soft tissues around titanium abutments treated using different cleaning methods. Sixteen patients were randomized into three groups: laboratory customized abutments underwent Plasma of Argon treatment (Plasma Group), laboratory customized abutments underwent cleaning by steam (Steam Group), and abutments were used as they came from industry (Control Group). Seven days after the second surgery, soft tissues around abutments were harvested. Samples were histologically analyzed. Soft tissues surrounding Plasma Group abutments predominantly showed diffuse chronic infiltrate, almost no acute infiltrate, with presence of few polymorphonuclear neutrophil granulocytes, and a diffuse presence of collagenization bands. Similarly, in Steam Group, the histological analysis showed a high variability of inflammatory expression factors. Tissues harvested from Control Group showed presence of few neutrophil granulocytes, moderate presence of lymphocytes, and diffuse collagenization bands in some sections, while they showed absence of acute infiltrate in 40% of sections. However, no statistical difference was found among the tested groups for each parameter (p>0.05). Within the limit of the present study, results showed no statistically significant difference concerning inflammation and healing tendency between test and control groups.


2019 ◽  
Vol 29 (1) ◽  
pp. 5-9
Author(s):  
Khairunnisak Misron ◽  
Tengku Mohamed Izam Tengku Kamalden

Introduction: Totally endoscopic ear surgery (TEES) is defined as exclusive application of endoscope transcanally in otologic surgery. This study is aimed to highlight indications and ear pathologies for TEES. In addition, intraoperative, early postoperative and delayed postoperative complications of TEES will be also described in this study. Methodology: This is a retrospective study of TEES performed by a single experienced and trained otologist in endoscopic ear surgery in a single institution between 1 July 2014 and 31 June 2018. A total of 43 patients were recruited in this study. Sociodemographic information, indications for TEES, ear pathologies, type of surgery performed and complications of TEES were analyzed. Results: The indications for TEES comprised middle ear lesion (65.1%), followed by second look surgery (14.0%), external auditory canal lesion (11.6%) and internal acoustic meatus lesion and surgery for conductive hearing loss which were 4.7%. Various external auditory canal pathologies encountered for TEES were ear canal osteoma (4.7%), acquired ear canal stenosis (2.3%) and tumor (4.7%). Regarding middle ear pathologies, limited atticoantral cholesteatoma accounted for most of the cases, 46.5%. Other middle ear lesions included adhesive otitis media (14.0%), recurrent cholesteatoma (14.0%), tumor (4.7%), otosclerosis (2.3%) and ossicular discontinuity (2.3%). Internal acoustic meatus lesion constituted 4.7% of cases. Some 4.7% of cases developed intraoperative complications, while early and delayed complications were 7.0%. Conclusion: TEES is a feasible surgical technique for diverse ear pathologies in the otologic specialty. It is also proven to be safe with good surgical outcomes.


2014 ◽  
Vol 1 (2) ◽  
Author(s):  
Laili Chilmawati ◽  
Heru Pradjatmo ◽  
H.R. Siswosudarmo

PENGARUH PEMBERIAN ASAM TRANEKSAMAT TERHADAP JUMLAH PERDARAHAN PASCASALIN PADA KELAHIRAN VAGINALLaili Chilmawati1 , Heru Pradjatmo2, H.R. Siswosudarmo3 ABSTRACT Background: Maternal mortality is the great problem in developing countries and postpartum hemorrhage is the main cause. Obstetrics intervention and uterotonics agents have been used to control postpartum hemorrhage, but the use of hemostatic agent is still in the study.Objective: To compare the effect of tranexamic acid on postpartum hemorrhage and its potential side effects compared with placebo in vaginal deliveryMethods: A Double blindrandomized controlled Trial (RCT). We conducted a total of 198 subjects who met the inclusion criteria were recruited. The treatment group was those who got one gram tranexamic injection and the the control group those who got placebo. Independent sample t-test, chi-square and linear regression were used for statistical in treatment group analysis.Results and Discussion: A total of 198 subjects met the inclusion criteria, consisting of 99 subjects and 99 in the control group. No significant difference was found on the amount of postpartum hemorrhage (102.13±67.34 ml vs.110.58±73.57 ml;p=0.40), nor on the difference of hemoglobin level (0.99±1.13 g/dLvs.1.05 ± 0.93 g/dLp=0.66), and of hematocrit level (4.06 ± 3.73 vs.4.58±4.18%;p=0.36). The use of other uterotonics gave the significant difference at the decrease of hemoglobin level (p=0,02). Side effect of nausea and vomiting at tranexamic acid group didn’t differ from placebo (p=1,00).Conclusion: There was no difference between the use of tranexamic acid and placebo in terms of number of bleeding the decrease of haemoglobin and hematocrit. Keywords: tranexamic acid; postpartum hemorrhage; hemoglobin and hematocryte level, vaginal delivery. ABSTRAK Latar belakang: Kematian ibu merupakan masalah yang besar di negara sedang berkembang. Perdarahan pascasalin merupakan penyebab paling utama kematian ibu. Intervensi obstetrik dan obat-obat uterotonika telah digunakan secara optimal untuk mengatasi perdarahan pascasalin, tetapi obat hemostatik masih dalam kajian.Tujuan: Mengetahui pengaruh asam traneksamat terhadap jumlah perdarahan pascasalin pada persalinan vaginal dan efek samping yang mungkin terjadi.Metode Penelitian: Metode penelitian ini adalah Randomized Controlled Trial (RCT). Subyek penelitian adalah pasien dengan persalinan vaginal yang memenuhi kriteria inklusi dan eksklusi. Kelompok penelitian adalah mereka yang mendapat injeksi asam traneksamat 1 gram intravena sedang kelompok control adalah mereka yang mendapat plasebo. Independent t-test, chi-square dan regresi linier digunakan untuk analisis statistika.Hasil dan Pembahasan: Sebanyak 198 subyek memenuhi memenuhi kriteria kelayakan, terdiri atas 99 subyek masuk ke dalam kelompok perlakuan dan 99 subyek yang masuk dalam kelompok kontrol. Tidak didapatkan perbedaan secara bermakna pada jumlah perdarahan kala IV (102,13±67,34 ml vs 110,58±73,57 ml, p=0,40), penurunan kadar hemoglobin (0,99±1,13 g/dLvs.1,05±0,93 g/dL, p=0,66) dan penurunan kadar hematokrit (4,06±3,73 vs.4,58±4,18%, p=0,36). Penggunaan uterotonika lain memberikan perbedaan secara signifikan terhadap penurunan kadar hemoglobin (p=0,02). Kadar hemoglobin awal dan kadar hematokrit awal memberikan perbedaan secara signifikan terhadap penurunan kadar hematokrit (p=0,006 dan 0,01). Kejadian efek samping mual dan muntah pada pemberian asam traneksamat tidak berbeda dibandingkan dengan plasebo (p=1,00).Kesimpulan: Jumlah perdarahan kala IV, penurunan kadar hemoglobin dan penurunan kadar hematokrit tidak berbeda antara kelompok yang mendapat asam traneksamat dibanding yang mendapat placebo. Kata kunci: asam traneksamat, perdarahan pascasalin, kadar hemoglobin, hematokrit. 1 PPDS 1 Obstetri dan Ginekologi, Bagian Obstetri dan Ginekologi, Fakultas Kedokteran UGM2,3 Bagian Obstetri dan Ginekologi, Fakultas Kedokteran UGM


2019 ◽  
Vol 24 (2) ◽  
pp. 100-108
Author(s):  
Ji Eun Choi ◽  
Jae-Hun Lee ◽  
So-Young Chang ◽  
Min Young Lee ◽  
Jae Yun Jung

Background: Endoscopic ear surgery has recently increased, but it is still inconvenient and time-consuming to place packing material in the middle ear with one hand. Poloxamer 407 (P407) is a thermo-reversible gel that can be easily administered with one hand into the middle ear cavity in liquid form. Upon warming to body temperature, the gel form of P407 can support the graft in the target position and is known to prevent postsurgical tissue adhesion. Objectives: We aim to investigate the feasibility of P407 as packing material in an animal model. Male Hartley guinea pigs (350 and 400 g) were utilized in this study. Method: The animals were randomly divided into 3 groups according to the packing material: the control group, the P407 group, and the gelatin group. To assess the role of packing material on bacterial colonization, left ears were inoculated with Streptococcus pneumoniae through the tympanic membrane using a 0° endoscope. Five days after inoculation, the middle ear cavity was packed through a transbullar approach using 18% P407 or gelatin in both ears. In the control group, no ear pack was inserted. The tympanic membrane was examined every week using a 0° 1.9-mm endoscope until 6 weeks. Half of the animals in each group were sacrificed 6 weeks after placement of the packing materials. Results: Compared with the absorbable gelatin sponge, the P407 group showed little inflammation or fibrosis in the tympanic membrane and middle ear mucosa regardless of bacterial inoculation. The gelatin group showed severe otorrhea or perforation until 2 weeks in the right ear (2 of 4) and the left ear (1 of 4). Even though the endoscopic findings were similar between both packing groups at 6 weeks, histological analysis showed persistent packing material, inflammatory cells, and fibrosis in the gelatin group compared to the P407 group. Conclusions: This study suggested that P407 is feasible as a packing material to handle with one hand and to prevent adhesion, especially in infected middle ear mucosa. Although there is a lack of data on how well P407 supports grafts, we suggest that P407 could be a candidate for packing material in endoscopic ear surgery.


2018 ◽  
Vol 33 (1) ◽  
pp. 6-11
Author(s):  
Jenna Marie C. Quiroga ◽  
Peter Simon R. Jarin

Objectives: To determine the effect of a single intravenous dose of tranexamic acid on intraoperative bleeding, duration of surgery, and surgical field visualization during endoscopic sinus surgery.   Methods:             Study Design: Double-blind, randomized, placebo-controlled trial.             Setting: Tertiary Government Hospital in Quezon City             Participants: 10 patients aged 18-75 years old diagnosed with chronic rhinosinusitis with or without nasal polyposis and unresponsive to medical treatment, who underwent endoscopic sinus surgery from September 2016 to August 2017, were randomly allocated to treatment group and control group respectively. The “odd” numbers were assigned to the treatment group (intravenous Tranexamic acid) given 1 dose of 100mg/ml (500mg tranexamic acid per 5 ml) tranexamic acid slow intravenous drip 1 hour prior to the procedure, while the “even” numbers assigned to the control group received the same amount of normal saline solution.   Results: The mean duration of surgery of the tranexamic group was 185 minutes (standard deviation, SD 55.23) and the control group was 122.6 minutes (SD 42.03) showing no significant difference (p=.08). The mean blood loss of the tranexamic group was less at 240ml (SD 108.39) compared with the control group at 290ml (SD 74.16), although there was no statistically significant difference (p=.42). Intraoperative surgical field assessed by the surgeon based on the Boezart grading scale showed that 2 (40%) of the tranexamic group had higher bleeding score compared with the placebo group. However, this was not found to be statistically significant (p=.460). Due to the small sample size, a type II error occurred with alpha level of 0.05 and estimated power of 0.0885, with not enough basis to refute that a single dose of intravenous tranexamic acid has no effect in improving surgical field visualization during endoscopic sinus surgery. No drug side effects were noted after administration until after surgery.   Conclusion: Single dose intravenous tranexamic acid in functional endoscopic sinus surgery decreased mean intraoperative blood loss (but this was statistically insignificant), but its effect on surgical field visualization cannot totally be assessed due to small sample size. There was also no change in the observed duration of surgery. No untoward side effects associated were noted from administration of the drug until after the surgery finished.   Keywords: Functional endoscopic sinus surgery, intravenous tranexamic acid, chronic rhinosinusitis


2020 ◽  
Vol 20 (2) ◽  
pp. 101-120
Author(s):  
Ayça Aktaç Gürbüz ◽  
Orçun YORULMAZ ◽  
Gülşah DURNA

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.


2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Farokh Saljughi ◽  
Mitra Savabi-Esfahani ◽  
Shahnaz Kohan ◽  
Soheila Ehsanpour

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.


2018 ◽  
Vol 7 ◽  
Author(s):  
Azita Kamjoo

Background: Pain control is considered as the key issue in modern midwifery. Along with medical painkillers, reflexology is viewed as a non-medical and noninvasive method. Hence, we aimed to investigate the effect of reflexology on the intensity of pain and length of labor. Materials and Methods: In this clinical trial, participants included 240 Iranian primiparous women with term and singleton pregnancy. Having a 3-4 cm cervical dilatation once they visited the hospital. Through a convenient sampling method, they were selected and then randomly divided into two groups. In the intervention group, reflexology was performed, and the intensity of pain during the active phase of labor along with the length of labor in the active phase was measured by visual analog scale (VAS) and compared with the control group. Data were analyzed using descriptive statistics, t-test, and Mann-Whitney U-test. Result: Data analysis showed a statistically significant difference between the intensity of pain in the 5-7 and 8-10 cm dilatation in the two groups (P=0.01). Moreover, the labor length in the active phase was found to be significantly shorter in the intervention group (P<0.001). Conclusion: It appears that reflexology can lead to a reduction in the pain and length of labor. Therefore, through instructing this technique, a goal of midwifery, which is reducing labor pain and its length can be achieved. Keywords: Reflexology, Labor Pain, Labor Length, Primiparous Women


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