European Archives of Oto-Rhino-Laryngology

, Volume 270, Issue 9, pp 2451–2454

Evaluation of intraoperative bleeding during an endoscopic surgery of nasal polyposis after a pre-operative single dose versus a 5-day course of corticosteroid

Authors

    • Department of OtolaryngologyShahid Sadooghi University of Medical Sciences
    • Department of OtolaryngologyShahid Sadooghi Hospital
  • Mohammad Reza Azimi
    • Department of OtolaryngologyShahid Sadooghi University of Medical Sciences
  • Seyyed Abbas Mirvakili
    • Department of OtolaryngologyShahid Sadooghi University of Medical Sciences
  • Mohammad Hossein Baradaranfar
    • Department of OtolaryngologyShahid Sadooghi University of Medical Sciences
  • Mohammad Hossein Dadgarnia
    • Department of OtolaryngologyShahid Sadooghi University of Medical Sciences
Rhinology

DOI: 10.1007/s00405-012-2340-9

Cite this article as:
Atighechi, S., Azimi, M.R., Mirvakili, S.A. et al. Eur Arch Otorhinolaryngol (2013) 270: 2451. doi:10.1007/s00405-012-2340-9

Abstract

Nasal polyps are associated with the inflammation of the nasal cavity and the sinus mucosa. When medical treatment cannot solve a patient’s problem, a functional endoscopic sinus surgery may be indicated. Bleeding impairs the surgery field during operation and increases the operation risk and time. Pre-operative corticosteroids can reduce bleeding during surgery. In this study, we have evaluated the effect of pre-operative single-dose prednisolone (1 mg/Kg/dose 24 h before surgery) versus 5-day prednisolone (1 mg/Kg/day before operation) on the bleeding volume and the surgery field quality during FESS. In this mono blind randomized clinical trial, 80 patients with bilateral nasal polyps were randomly assigned in two groups. The first group (A) received a single dose of 1 mg/Kg/dose prednisolone on the day before the surgery. The second group (B) received 1 mg/Kg/day prednisolone for 5 days before the operation. The patients were operated on under general anesthesia through the same protocol. The mean arterial blood pressure was 70–80 mm Hg in both groups. The surgeons were not aware of the patients’ group. The bleeding volume and the surgeons’ opinion about the surgery field quality were recorded at the end of the procedure and analyzed by Chi-square and t test. The two groups were not significantly different in their overall demographic and clinical characteristics. The mean bleeding volume during the operation was 266.5 ± 96.31 ml in group A and 206 ± 52.81 ml in group B; there was a significant difference between the groups (P value = 0.038). There was no significant difference between the groups in the surgeons’ opinion about the surgery field quality (P value = 0.09). In conclusion, unlike a single dose (1 mg/kg/dose), treatment with 5-day prednisolone (1 mg/kg/day) can reduce blood loss during FESS more efficiently and may improve the surgery field quality slightly. But this difference is not clinically significant.

Keywords

Nasal polypsPrednisoloneEndoscopic sinus surgeryBleedingComplicationCorticosteroids

Introduction

Rhinosinusitis is an inflammatory process in nose and paranasal sinuses characterized by at least two of these: clinical presentation, endoscopic finding, and CT scan changes [1]. Many patients may be asymptomatic, but large polyps may lead to a nasal passage block and become symptomatic. The most common symptoms are hyposmia, rhinorrhea, posterior nasal discharge, etc [2]. There is a correlation between nasal polyps and allergy. 68.5 % of patients with nasal polyps had a positive allergy skin test although allergy may not be responsible for the rhinosinusitis [3]. Medical therapy for nasal polyps is the main stage of treatment. It consists of a course of antibiotics with an effective bacterial coverage and topical steroids [4]. Long-term topical steroids with a reduction in the polyp size can remove patients’ symptom. Short-term systemic steroids may be used in more severe cases [5]. When medical treatment cannot solve the patients’ problem, surgery may be indicated. The best approach for chronic rhino sinusitis with nasal polyps is a functional endoscopic sinus surgery [6]. One of the most common complications during FESS is bleeding [7]. Bleeding impairs the surgery field during the operation and increase the risk of complications like those in the skull base or orbital damages. Bleeding increases operation time due to multiple stops during surgery for suctioning and packing [7]. One of the strategies to reduce bleeding during an operation is the use of pre-operative corticosteroid, which makes a reduction in the polyp size and mucosal inflammation [4].

In this study, we tried to answer the question: “can a pre-operative regimen of prednisolone be reduced to a single day before the procedure?” A single dose may be better complied with than a five-course one, and perhaps better tolerated. So, we evaluated the effect of pre-operative single-dose prednisolone (1 mg/Kg/dose 24 h before surgery) versus a 5-day prednisolone protocol (1 mg/Kg/day before surgery) on the bleeding volume and the surgery field quality during FESS.

Method and materials

A total of 80 patients with bilateral nasal polyps were the candidates for our mono blind randomized clinical trial. All the patients were in a good health condition (ASA class I) and aged between 18 and 50 (the inclusion criterion was age between 18 and 50). They were randomly assigned in two groups according to the table of random numbers. The first group (group A) received a single dose of 1 mg/Kg/dose prednisolone on the day before the surgery. The second group (group B) received 1 mg/Kg/day prednisolone for 5 days before the operation. The exclusion criteria were history of previous nasal surgery, antrochoanal polyps, hemorrhagic disease, hypertension (SBP > 140 mm Hg or DBP > 90 mm Hg), corticosteroid use in 2 months before screening, and allergy or other contraindications for corticosteroid use. Written consents were taken from the patients. The baseline assessment included the collecting of the patients’ medical and surgical history and nasal examination. The size of the nasal polyps was recorded in a diagnostic endoscopic examination, and the sinus involvement was determined by CT-scan images according to Lund–Mackay score. Treatment complications such as high blood glucose levels, euphoria, stomach irritation, and sleeplessness were recorded too. The study was approved by the ethics committee of Shahid Sadoughi Hospital, Yazd, Iran.

The patients were operated on under general anesthesia by the same protocol (Table 1). The mean arterial blood pressure was 70–80 mm Hg in both groups during the surgery. All the surgeons used topical vasoconstriction (1/10,000 epinephrine solution) and used a 2-ml local injection of 1/100,000 epinephrine solution in the middle and inferior turbinate and to the attachment of the middle turbinate to the lateral nasal wall. The surgeons were not aware of the patients’ group. The bleeding volume was precisely assessed according to the volume in the suction jar (total volume minus irrigation volume) and the excess weight of the pharyngeal pack. The surgeons’ opinion about the surgery field quality was recorded according to 0–10 score (Table 2) at the end of the procedure.
Table 1

Anesthesia protocol

Premedication

Midazolam 1 mg IV + fentanyl 2.5 micro g/kg IV + clonidine 1 tablet

Induction

Propofol 1.5–2 mg/kg + atracurium 0.5 mg/kg

Maintenance

Propofol 5–10 mg/kg/h + atracurium 0.5 mg/kg itch 30 min + N2O 50 %

If MAP > 80 mm Hg

TNG drip 0.25-0.5 micro g/kg/min till MAP < 80 mm Hg

Table 2

Quality of surgical field during functional endoscopic sinus surgery

Score

Quality of intraoperative surgical field during functional endoscopic sinus surgery

0–1

No bleeding; excellent to outstanding surgical conditions

2–3

Slight bleeding. Surgery fairly easy. No stop for hemostasis and/or suctioning is required

4–5

Slight bleeding. Surgery mildly difficult. One stop for hemostasis and/or suctioning is required

6–7

Moderate bleeding. Surgery Moderately difficult. Occasional stops for hemostasis and/or suctioning are required

8–9

Moderate to severe bleeding. Surgery very difficult. Multiple stops for hemostasis and/or suctioning are required.

10

Surgery terminated due to severe bleeding in surgical field

A sample t test and Chi-square test were used to compare the baseline and the outcome values. Differences would prove to be statistically significant if P value was less than 0.05. All the statistical analyses were performed with an SPSS software version 11.5 for windows.

Results

80 patients who had the inclusion criteria were randomly assigned in two equal groups. The overall demographic as well as the clinical characteristics was not statistically different in the two groups at the baseline (Table 3). The prevalence of concomitant asthma in two groups was also mentioned in Table 3, but the difference was not significant.
Table 3

Pre-operative variables

 

Group A

Group B

p value

Age (mean ± SD)

37.3 ± 10.47

34.85 ± 9.48

0.44

Sex (m/f)

1.85/1

3/1

0.49

Concomitant asthma

7.5 %

12.5 %

1.00b

CT-score (Lund-Mackay) (mean ± SD)

19.45 ± 2.51

19 ± 2.81

0.59

Polyp gradea

Grade Ι: 4

Grade Ι: 2

0.60

Grade II: 18

Grade ΙΙ: 14

 

Grade ΙΙΙ: 18

Grade ΙΙΙ: 24

 

aAccording to Lund–Mackay (table 4)

bFisher’s exact test

Table 4

polyp size and CT scan score (Lund-Mackay) in groups

 

Polyp size (mean)

Ct scan score

Single dose

2.35

19

Multiple dose

2.55

19.45

P value

0.328

0.599

The mean bleeding volume during the operation was 266.5 ± 96.31 ml in group A and 206 ± 52.81 ml in group B. In this regard, there was a significant difference between the groups (P value = 0.038).

The surgeons’ evaluation about the surgery field quality is recorded in Fig. 1. As it can be seen, the two groups were not significantly different (P value = 0.09).
https://static-content.springer.com/image/art%3A10.1007%2Fs00405-012-2340-9/MediaObjects/405_2012_2340_Fig1_HTML.gif
Fig. 1

Surgeons’ opinion about surgical field quality

A treatment complication (euphoria) was seen in one of the patient in the 5-day treatment, but none of the patients in the other group had a side effect. There was no statistically significant difference between the two groups in this respect (P value = 0.31).

Discussion

In the present study, there was no statistically significant difference between the groups in terms of age, polyp size, and CT scan scores prior to the surgery. The only difference was the duration of pre-operative prednisolone use. The results showed that the use of 1 mg/Kg/day prednisolone for 5 days pre-operatively could reduce the intraoperative bleeding volume during FESS in comparison with 1 mg/Kg prednisolone used only 1 day before the surgery. A control group (without any steroid treatment) was planned, but not approved by the Ethics Committee, as steroids have shown to be effective.

Although the surgeons’ evaluation about the surgery field quality in the 5-day prednisolone protocol was better than that in a single-dose administration, the difference was not statistically significant. In other words, although the volume of blood loss in the 5-day regimen was less than that in the single-dose regimen, the effect was not significantly different clinically.

In Albu’s study where the effect of local corticosteroid was evaluated on bleeding volume reduction during FESS, half of the patients were treated with a nasal spray and the others were treated with a placebo. The result showed that the bleeding volume reduction in the patients who used a nasal spray was statistically less than that in the other group. Also, the surgeon had a better opinion about the surgery field in the nasal spray group [8].

In another study by Giordano, the effect of local corticosteroid on bleeding volume and the surgeon’s evaluation were investigated. 21 patients were treated by oral prednisolone (1 mg/Kg for 7 days before surgery) and 19 with a placebo. The results did not show any significant difference between the two groups according to the bleeding volume; however, the rate of sinus involvement was higher in the group that received oral prednisolone than in the placebo group [9].

In Kirtsreesakul’s study, the patients were divided into two groups. In the first group, the patients were treated with oral prednisolone (30 mg/day) and in the second group, they were treated with a placebo. The results showed although the bleeding volume was a little less in the test group, the surgery field had a significant improvement [10].

An aim of the present study was to evaluate the side effects of short-term use of corticosteroid. The results showed that the side effects were less in the single-dose group, but the difference was not statistically significant (P value = 0.31).

In a study, Bolanos showed that short-term corticosteroid use was safe and side effects such as sleep disorders, weight gain, euphoria, and gastrointestinal disorders were seen rarely according to a meta-analysis done in 2005. Severe side effects were seen in 6 % of the patients while mild–moderate side effects were seen in 28 % of the patients. The most common side effects in short-term corticosteroid use were hypomania and euphoria. It was due to hypocamp neurons disequilibrium [11].

In the Sieskiewicz study, bleeding and surgeon evaluation was compared in 18 patients on 30 mg of oral prednisone daily for 5 consecutive days before the operation with control group. Although total blood loss was reduced slightly in steroid group, but surgical field improved significantly as a result of the anti-edematous and anti-inflammatory activity of steroid, which provided a better vision for the surgeon [12].

Conclusion

Treatment with 5-day prednisolone (1 mg/kg/day) as compared to single-dose prednisolone (1 mg/kg/dose) can reduce blood loss during FESS more efficiently, but may not improve surgery field quality significantly. So, in case of time restriction, a single dose of prednisolone before operation may be useful for the reduction of bleeding volume and the improvement of surgeon’s opinion. Also, it has no side effect or complication.

Copyright information

© Springer-Verlag Berlin Heidelberg 2013