Topical tranexamic acid versus hot saline for eld quality during endoscopic sinus surgery

In an eff ort to reduce bleeding during FESS and thus improve visualization, many surgeons use techniques such as hypotensive anesthesia, elevation of the head of the bed during surgery, and administration of local vasoconstrictors [8]. For nasal bleeding, tranexamic acid has been suggested to improve hemostasis and improve the surgical fi eld [9]. Tranexamic acid can be administered topically or intravenously. In the clotting cascade, it serves to stabilize the fi brin clot and reduce overall bleeding [10]. Th e mechanism of action topical antifi brinolytics (tranexamic acid) is competitive binding with the lysine site on plasminogen. Th is prevents fi brinolysis and stabilizes the blood clot, potentially decreasing further bleeding. Conversely, a low dose (100 mg) of tranexamic acid provided hemostasis and improved quality of the surgical fi eld at 2, 4, and 6 min after application (P < 0.05). No adverse eff ects were found after topical application [11].


Introduction
Functional endoscopic sinus surgery (FESS) is frequently used in the treatment of recalcitrant chronic rhinosinusitis (CRS) [1]. Bleeding is a common inevitable complication that results from impaired visibility of ruptured blood vessels because of excessive bleeding during surgery [2], which takes a major concern for both anesthesiologists and otolaryngologists [3].
Bleeding during FESS can interfere with surgeon visibility, and then the surgeon will have to use suction frequently and this will increase the risk of further manipulation of fi eld, more bleeding, and longer surgery duration. It also increases the risk of possible injuries of the vasculature of the eye and intracranial complications [4,5].
Th e most important source of bleeding during endoscopic sinus surgeries is the capillaries, and therefore mean arterial pressure (MAP) can infl uence the severity of bleeding [6,7].
In an eff ort to reduce bleeding during FESS and thus improve visualization, many surgeons use techniques such as hypotensive anesthesia, elevation of the head of the bed during surgery, and administration of local vasoconstrictors [8].
For nasal bleeding, tranexamic acid has been suggested to improve hemostasis and improve the surgical fi eld [9]. Tranexamic acid can be administered topically or intravenously. In the clotting cascade, it serves to stabilize the fi brin clot and reduce overall bleeding [10]. Th e mechanism of action topical antifi brinolytics (tranexamic acid) is competitive binding with the lysine site on plasminogen. Th is prevents fi brinolysis and stabilizes the blood clot, potentially decreasing further bleeding. Conversely, a low dose (100 mg) of tranexamic acid provided hemostasis and improved quality of the surgical fi eld at 2, 4, and 6 min after application (P < 0.05). No adverse eff ects were found after topical application [11].
Hot water irrigation is an eff ective method of treating severe, life-threatening epistaxis [12,13]. In addition, it has recently been demonstrated that hot water irrigation, using temperature of up to 50°C, produces vasodilatation and edema of the nasal mucosa without the risk of necrosis. Th is mucosal edema leads to local compression of the bleeding vessels while at the same time triggering and probably accelerating the clotting cascade [14]. Vasodilatation also leads to decreasing the fl ow and the intraluminal blood pressure. Another benefi t of warm water irrigation is that it allows the cleaning of the endoscopic lens [15].

Objectives
This study conducted to evaluate and compare between topical tranexamic acid (TA) and hot saline as an alternative to local vasoconstrictors on bleeding and surgery site quality during endoscopic sinus surgery (FESS).

Patients and methods
This study was performed on 75 patients with class I and II American society of anesthesiologists (A.S.A.), scheduled for elective FESS under general anesthesia. Patients divided into three groups, each (25 patients), group A: topical tranexamic acid (1000mg diluted in 20ml normal saline) was used during surgery for packing and irrigation, group B: hot saline up to 50°C was used and group C :(control group) normal saline was used.

Results
The use of local (TA) was associated with signi cant decrease in estimated blood loss 214.2 ml more than local hot saline which was 216.75 and both is much better than the normal saline which was 272.66. Also (TA) and hot saline showed decrease in the duration of surgery, improve the surgical eld quality and blinded surgeon satisfaction as compared with the control group. was used to prevent blood from lowering down to the pharynx. Anesthesia maintained by isofl urane inhalation and muscle relaxant. MAP was maintained between 60 and 70 mmHg by using nitroglycerine infusion (5-10 g/kg/min). After surgery, muscle relaxant was reversed with atropine (0.02 mg/kg) and neostigmine (0.05 mg/kg).
Hemodynamic parameters such as MAP and heart rate were recorded every 15 min. Prothrombin time, partial thromboplastin time, and complete blood count were carried out preoperatively and 6 h postoperatively. Any side eff ects of treatment such as nausea or vomiting were reported.
Blood loss intraoperatively was estimated by the attending anesthesiologist by counting the bloodsoaked mops and gauze pieces, multiplying them by the estimated volume of blood they carried, and also measuring blood lost to suction bottles and estimating it after subtraction of irrigation fl uid.
Th e surgical fi eld was fi rst suctioned clear of blood and then graded by the surgeon using the scale of Boezaart et al.
[2] ( Table 1). Th e surgeon adopted a wait and watch approach with the aid of endoscopy during and at the end of surgery to detect fresh bleeding. If the bleeding observed was due to an infl amed residual polyp, the polyp was removed and the patient was observed for any further bleeding. If the bleeding was from a particular spot, the spot wa s cauterized and again checked for further bleeding. All patients were packed with Merocell (Medical product Ltd. C0ronet House, Kearstey Road Ripon, North Yorkshire, HG4, UK) for 24 h.
Statistical analysis of the collected data was performed by using SPSS version 17 (Chicago , Illinois, USA). Quantitative data were presented as mean and SD and wer e analyzed by using one-way analysis of variance test. Qualitative data was presented as numbers and percentages and were analyzed using 2 -test and Fisher's exact test. P-value less than 0.05 was considered signifi cant, whereas P-value less than 0.01 was considered highly signifi cant.
Th e aim of this study was to evaluate and compare between topical tranexamic acid and hot saline on bleeding and quality of the surgery site during endoscopic sinus surgery.

Patients and methods
Following approval of the ethics committee, informed written consent was obtained from the patients. A total of 75 patients with bilateral CRS with or without polypi, both male and female, between the age of 20 and 50 years, body weight ranging from 60 to 100 kg and classifi ed according to the American Society of Anesthesiologists (ASA I and II), were randomly selected from the ENT Department lists from the period of December 2011 to October 2013.
Patients with unilateral or previous FESS, cerebrospinal fl uid rhinorrhea, benign or malignant tumors, pregnant or breast feeding, known allergy to antifi brinolytics, any bleeding diathesis, previous cardiac surgery, severe anemia, liver or kidney disorder, hypertension, uncontrolled diabetes, immunodefi ciency disease, or on long-term medications such as steroids, nonsteroidal drugs, and chemotherapeutics were excluded from this study.
Patients were divided into three groups, each comprising 25 patients. In group A, tranexamic acid (1000 mg diluted in 20 ml normal saline) was used for packing and irrigation during surgery. In group B, hot saline was prepared by placing sterile normal saline (9%) into a basin, and then the basin was placed in a medical-grade warmer and the temperature up to 50°C. Th e external digital thermometer is also placed in the saline at all times to ensure that the temperature is about 50°C, and was used for packing and irrigation during and after surgery. In group C, normal saline was used for packing and irrigation during surgery.
All patients were premeditated with midazolam (0.02 mg/kg) and fentanyl (2 mg/kg). After monitoring, anesthesia induction with propofol (2 mg/kg), atracurium (0.5 mg/kg), and lidocaine was given (1.5 mg/kg) before intubation. At the beginning of the procedures, nasopharyngeal pack with gauze Th e blinded surgeon's satisfaction about the signifi cant reduction in bleeding during the operation showed that there was signifi cant reduction in bleeding in groups A and B in comparison with group C; however, there were no signifi cant diff erences between groups A and B (Table 4).
Th ere were no signifi cant diff erences between the three groups, either preoperative or postoperative in the coagulation profi le (Table 5).
Th e duration of surgery showed signifi cant increase in time in group C (control group) compared with groups A and B. However, no signifi cant diff erences were observed between groups A and B (Table 6).
Th e blood loss during surgery showed no signifi cant diff erences between groups A and B; however, the amount of bleeding showed a signifi cant increase in group C (control group) in comparison with the other two groups (Table 7).

Results
Th is study was conducted on 75 patients with CRS with age ranging from 20 to 50 years, with mean ± SD of 35.88 ± 10.3 in group A, 36.52 ± 10.9 in group B, and 31.56 ± 12.1 in group C. Th ere were no signifi cant diff erences between the three groups.
With regard to the bleeding scores in the three groups, according to the Boezaart grading scale, less bleeding was noticed in groups A and B, and more bleeding in group C. Th ere were signifi cant diff erences between groups A and B and group C, but no signifi cant diff erences between groups A and B (Table 2).
According to the MAP, intraoperatively there were no signifi cant diff erences between the three groups (Table 3).   and C, with a P-value of 0.0003; however, there were no signifi cant diff erences between groups A and B. Moreover, the tranexamic acid group was better than the hot saline group.
With respect to the level of blinded surgeon satisfaction about the quality of fi eld during the surgery, the mean number of positive answers in group A was 0.92 ± 0.27, that in group B was 0.88 ± 0.33, and that in group C was 0.32 ± 47.04, with P-value less than 0.05. Th ere were signifi cant diff erences and this is in accordance with a study by Abbasi et al. [17] who appreciated the use of topical tranexamic acid in nasal sinus surgery, and Ozmen and Ozmen [16] as they demonstrated that the 50°C saline irrigation was more eff ectual for hemostasis in comparison with room temperature (25°) saline irrigation [14].
With regard to the coagulation profi le of the three groups (platelet count, prothrombin time preoperative and postoperative, partial thromboplastin time preoperative and postoperative), the study showed no signifi cant diff erences between the three groups and this is in agreement with most of the earlier studies, such as Brown et al., [18] Jabalameli et al., [19] and Wellington et al. [21].
Th e time of surgery was 75.92 ± 7.64 min in the group A, whereas in group B it was 74.22 ± 7.54 min and 98.54 min in group C (P = 0.0002), and this showed signifi cant diff erences between both groups A and B and group C, and this in accordance with Jebel et al. [22] who concluded that using tranexamic acid can decrease bleeding and duration of surgery, and Ozmen and Ozmen [16] who stated that 50° hot saline irrigation provides a lesser hemostasis time and reduce operative time.
Th e mean amount of collected blood during surgery was 214.2 ± 0.77 ml for group A, 216.75 ± 1.45 ml for group B, and 272.66 ± 1.78 ml for group C, showing signifi cant diff erences between groups A and B and group C (control group). Th ere were no signifi cant diff erences between groups A and B, although the amount of blood collected from group A was less. Th is is in agreement with the results of most of the previous studies such as that of Mottaghik et al. [23].

Conclusion
Bleeding during FESS remains a challenge for both surgeons and anesthesiologists.
Early postoperative nausea but not vomiting was reported in 12% of the patients in group A, 4% in group B, and 4% in group C. None of the studied patients showed signs or symptoms of thromboembolic events.

Discussion
Th e quality of the fi eld was considered the most important factor during FESS. Many methods have been used to reduce bleeding during sinus surgery to allow for the best surgical view and to reduce the risk of complications in surgery [2,16]. Controlled hypotension is used as an aid to reduce bleeding in patients undergoing middle ear or nasal surgery [2,17].
Tranexamic acid is an antifi brinolytic agent that reduces bleeding following certain surgical procedures [18]. Th e side eff ects of systemic tranexamic acid are mainly gastrointestinal in nature such as nausea, vomiting, and diarrhea. Giddiness and hypotension have also been reported. Worldwide postmarketing reports have shown thromboembolic events as deep vein thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction. Th e main advantage of topical application of tranexamic acid is to lower the risk of side eff ects by reduced systemic absorption [19,20].
Topical hot saline irrigation has been described as a simple and noninvasive technique to control bleeding sites and produce hemostasis.
Th is study used strict inclusion and exclusion criteria to ensure a homogeneous population so that a standardi zed anesthetic protocol could be applied.
In this study, we did not use vasoconstrictors or microdebrider. Th e eff ectiveness of application and irrigation of topi cal hemostatic agent during FESS is assessed in this study.
Th e results of the study verify the effi cacy of local tranexamic acid and local hot saline in rendering a bloodless surgical fi eld during FESS. Th e results were independent of demographic or hemodynamic variables to prevent the introduction of confounding factors. All operations were performed by the same team with the same technique.
With regard to the quality of the surgery site, based on the Boezaart grading scale, there were signifi cant diff erences between groups A and C and groups B