Septoplasties (nasal septal surgery) were commonly performed under general anaesthesia, but recently some investigators preferred local anaesthesia with conscious sedation.1,2 General anaesthesia is advantageous in sinonasal operations owing to the provision of full analgesia, safe airway and no requirement for patient cooperation.3,4 On the contrary, local anaesthesia has the advantage of not requiring airway penetration and mechanical ventilation, together with fewer cases of postoperative nausea–vomiting and headache.3,5 However, there is no consensus as to the procedure of choice. In prospective (sedation with midazolam) and retrospective (sedation with midazolam, fentanyl, and propofol) studies, in which comparisons were made between general anaesthesia and local anaesthesia with sedation during septoplasty, however, comparisons were not examined with respect to patient satisfaction with anaesthesia and nasal functions.3,5
Many investigators have reported the requirement of sedation for patient comfort during surgical operations with local anaesthesia.6,7 Recently, beneficial results have been obtained from the use of dexmedetomidine to provide sedation and reduce surgical bleeding during sinonasal operations.8,9
We hypothesized that local anaesthesia with dexmedetomidine provides better outcomes during septoplasties.
The aim of the present study was to compare general anaesthesia and local anaesthesia with dexmedetomidine sedation, primarily on the basis of postoperative pain and surgical bleeding after and during septoplasties. The other factors including nausea–vomiting, recovery period, patient satisfaction and postoperative nasal functions were compared.
This prospective and randomized study was approved by Baskent University Research Ethics Committee. Sixty patients with American Society of Anesthesiologists (ASA) physical status of 1 or 2 and undergoing nasal septal surgery were enrolled in the study after obtaining written informed consent. Exclusion criteria were age younger than 18 years or older than 70 years, use of analgesics or sedatives within the previous 24 h before the study and the presence of neurological or psychiatric disease. Patients were also excluded if they were significantly hypertensive or hypotensive or presented with any previous signs of heart disorders.
All patients received oral premedication with 10 mg diazepam during the evening before surgery. Using a computer-generated randomization schedule, patients were randomized to one of the following two groups: local anaesthesia with dexmedetomidine (LAD) group (n = 30) or the general anaesthesia group (n = 30).
In the LAD group, dexmedetomidine HCl (Precedex; Abbott Laboratories, Abbott Park, Illinois, USA) was administered as a bolus dose, 0.7 μg kg−1 over 10 min, and then a maintenance dose of 0.3 μg kg−1 h−1 intravenously to a Ramsay sedation scale (RSS) score of 3. Local anaesthesia was performed with 2% lidocaine HCI 10 ml added to 1: 80 000 adrenaline. In the general anaesthesia group only, 1: 80 000 adrenaline was administered for septal infiltration. Before the surgery was initiated, 10 min was allocated for the local anaesthetic and sedation to take effect.
In the general anaesthesia group, anaesthesia was initiated with 2.5 mg kg−1 propofol and 1 μg kg−1 fentanyl intravenously and then maintained with 1.0–2.0% isoflurane and 50% nitrous oxide in oxygen. In this group, tracheal intubation was facilitated with 0.5 mg kg−1 atracurium intravenously and the lungs were ventilated.
For the surgery, in both groups, the facial skin was prepared with povidone–iodine solution. The eyes were covered and drapes were arranged. Cotton pledgets soaked in 4% lidocaine and 0.05% oxymetazoline HCl were applied to the nasal cavities. The Cottle technique10 was used for septoplasties in all patients. Continuous septal sutures with 4/0 chromic cat-gut was carried out to prevent septal haematoma. Nasal packing was never placed.
Standard monitoring (Siemens SC 7000; Siemens Corporation, Danvers, USA) was used. Heart rate (HR) via electrocardiogram, noninvasive SBP, DBP and continuous pulse oximetry (SpO2) were obtained and measurements were recorded preoperatively (T0), at the 15th and 30th min intraoperatively (T1 and T2), at the end of the surgery (T3) and at the end of the recovery period (T4). Furthermore, in the LAD group, the level of sedation was measured by using the RSS score and analgesia was measured by using a visual analogue scale (VAS) performed with a 10 cm horizontal scale of 0 (no pain) to 10 (worst pain imaginable). Patients were informed about the scale preoperatively.
In all patients, the amount of intraoperative and postoperative blood loss, as well as the duration of surgery and recovery time, was recorded. Postoperative bleeding was determined using gauze counting and was followed up until the discharge time. Intraoperative blood loss was determined using suction volumes and gauze counting. Postoperative pain management was performed with 3 × 500 mg intravenous paracetamol infusion (500 mg/50 ml, Perfalgan; Bristol-Myers Squibb, Rueil-Malmaison, France).
When the intraoperative VAS score was 3 cm or more in the LAD group, fentanyl 1 μg kg−1 was administered intravenously as an additional analgesic. When the postoperative VAS score exceeded 3 cm, pethidine HCl (Liba, Vienna, Austria) 10 mg was administered intravenously and recorded in all the patients.
Postoperative nausea–vomiting was recorded and metoclopramide HCI 10 mg was given intravenously. In the general anaesthesia group, residual neuromuscular block was reversed by using atropine 0.5 and 1 mg neostigmine intravenously. Patients were deemed ready for discharge from the recovery room when they achieved a modified Aldrete score (MAS) of 10. All patients were discharged from the hospital the next day. Factors that led to delayed discharge were noted. All adverse events, including bradycardia (HR < 60 beats min−1), hypotension (SBP < 80 mmHg sustained for >10 min), oxygen desaturation (SpO2 <92%) and unplanned admissions were recorded during the study.
When patients returned to the hospital 1 week after discharge, they were questioned about their satisfaction with the anaesthesia technique (whether they preferred the same technique or another technique) and the quality of breathing (where 1 is better; 2 same as before; 3 worse; 4 awful).
The power analysis of the study was performed on the basis of the amount of surgical bleeding (ml) and postoperative pain scores, as indicated by VAS scores. For the surgical bleeding, the sample size was calculated according to a previous study reported by Ayoglu et al.8 They reported that the amount of surgical bleeding was 130 ± 73 ml in the standard general anaesthesia group, but only 52 ± 39 ml in the dexmedetomidine group in septoplasty patients. On the basis of the published data, we assumed that the surgical bleeding decreased 60% after the administration of dexmedetomidine (maximum difference between means 78 ml) and that the SD was 73 ml. If we assumed a two-tailed type I error of 0.05 and a power of 0.80, the necessary sample size of patients to be included in each group was 14. For the assessment of postoperative pain scores, the sample size was calculated according to our anaesthesia clinic's previous study of postoperative pain management after septoplasty or septorhinoplasty.11,12 We assumed that the VAS scores of the patients decreased by 45% after administration of local anaesthesia with dexmedetomidine during the postoperative period (maximum difference between means 1.6 cm) and that the SD was 2.0 cm. If we also assumed a two-tailed type I error of 0.05 and a power of 0.80, approximately 30 patients in each group were required to detect a difference of 1.6 cm in VAS score between the groups. We studied at least 30 patients in each group; thus, our study reached a power of 80%.
The results were analysed with SPSS 15.0 software for Windows (SPSS Inc., Chicago, Illinois, USA) and the statistical significance level was considered to be P < 0.05. Patient characteristics were compared with the χ2 test. Data between groups were compared with the Mann–Whitney U-test. Mean data were compared with the Student's t-test. All data are expressed as means ± SD.
Sixty-three patients were recruited to the study, but three patients were excluded because they did not want local anaesthesia. Thirty patients underwent general anaesthesia, whereas 30 patients underwent local anaesthesia with dexmedetomidine. Operations in all patients were successfully completed, and no patients in the LAD group needed to convert to general anaesthesia.
The characteristics of the patients are presented in Table 1. There were no significant differences in the patient characteristics (age, sex, ASA status) between the groups (P > 0.05). There was also no difference between the groups with respect to the duration of surgery; however, a significant difference was found between the groups in terms of the recovery time (P < 0.001), with a shorter recovery time in the LAD group. A significantly higher degree of postoperative nausea–vomiting was observed in the general anaesthesia group (P = 0.024).
The vital signs were also monitored during and after surgery in both groups. Statistical analysis showed a significant increase in HR in the general anaesthesia group at T1 compared with T0 (P = 0.005). There were significant reductions in HR in the LAD group at T3 and T4 compared with T0 (P = 0.044 and P = 0.041, respectively). The HR values at T1 and T3 were significantly higher in the general anaesthesia group than in the LAD group (P < 0.001 and P = 0.016, respectively). The SBP value was significantly decreased in the general anaesthesia group at T2 (P = 0.015); however, it was observed to be low throughout all measurement periods in the LAD group compared with T0 values (P = 0.011, P = 0.008, P = 0.004, P = 0.001, respectively). The SBP value at T2 was significantly higher in the LAD group than in the general anaesthesia group (P = 0.041). No significant changes were observed in the DBP values in the general anaesthesia group; however, there was a significant decrease in the DBP value in the LAD group at T2 compared with T0 (P = 0.017). No difference was observed between the groups with respect to the DBP value (P > 0.05). Severe hypotension, bradycardia or desaturation was not observed in any patient.
The mean intraoperative VAS score was 2.2 ± 1.1 cm in the LAD group; and additional analgesia was required in four of the 30 patients, as the VAS score was above 3 cm. The RSS score was found to be in the range of 2–4 in this group.
The amount of intraoperative bleeding was 41.67 ± 8.5 ml in the general anaesthesia group, whereas it was only 20.3 ± 4.8 ml in the LAD group; this difference between the groups was statistically significant (P < 0.001). The difference in the amount of postoperative bleeding was also significant (P < 0.001), as the amounts were 36.2 ± 8.3 ml in the general anaesthesia group and 22.2 ± 5.1 ml in the LAD group.
The mean postoperative VAS scores were 4.5 ± 1.54 cm in the general anaesthesia group and 1.8 ± 1.4 cm in the LAD group, and the difference between the groups was statistically significant (P < 0.001). The need for postoperative additional analgesia was found to be significantly lower in the LAD group than in the general anaesthesia group (16.6 and 90%, respectively; P < 0.001). The MAS of each patient was 10 at the time of discharge from the recovery room. Residual neuromuscular block was reversed in all of the patients in the general anaesthesia group.
All patients were discharged as scheduled on the next day following surgery without any problem. No unplanned visits to the hospital 1 week after discharge were recorded for any patient.
The proportion of patients who answered ‘I would have preferred the same anaesthetic technique’ during the first postoperative week questioning was found to be 56.6% (n = 17) in the general anaesthesia group and 83.3% (n = 25) in the LAD group (P < 0.05). Questioning regarding the quality of breathing demonstrated that 73.3% of the patients (n = 22) were better, 23.3% (n = 7) were the same as before and 0.03% (n = 1) were worse in the general anaesthesia group. In the LAD group, 80% of the patients were better (n = 24) with 20% the same as before (n = 6). No significant difference between the groups was observed with respect to the quality of breathing (P > 0.05).
The present study has demonstrated that septoplasties performed under local anaesthesia with dexmedetomidine sedation produce less surgical bleeding and postoperative pain and also less nausea–vomiting, a faster recovery period and a higher level of satisfaction with anaesthesia.
Hypotensive anaesthetic techniques during sinonasal operations are frequently used to provide better clarity of the surgical area.13,14 Dexmedetomidine has been shown to provide hypotensive anaesthesia during sinonasal operations under general and local anaesthesia.8,9 The administration of dexmedetomidine is also a commonly used technique in general anaesthesia to decrease bleeding by reducing intraoperative blood pressure. In the present study, patients were more hypotensive and bradycardic in the LAD group than in the general anaesthesia group (P < 0.05). This may be due to the absence of a hypotensive agent in the general anaesthesia group and also due to the anxiolytic and sympatholytic effects of dexmedetomidine in the LAD group.15
In the LAD group, adequate analgesia was provided under local anaesthesia with dexmedetomidine sedation (mean VAS score 2.2 ± 1.1). The analgesic effect of dexmedetomidine may also be explained by the presence of alpha-2 adrenergic receptors on nerve endings.16 Goksu et al.9 reported that adequate analgesia could be achieved with dexmedetomidine during sinus surgery under local anaesthesia (mean VAS score 3.2 ± 0.8). There were no difficulties associated with cooperation and unconsciousness with dexmedetomidine in the present study.
Bleeding during surgery was found to be less in the LAD group during both the intraoperative and postoperative periods. This may be due to the higher numbers of patients with hypotension in the LAD group. The difference in bleeding cannot be explained by septal infiltration of adrenaline as this was administered to both groups. Although bleeding during septoplasty is not generally severe enough to require blood transfusion, it may be a hindrance to the clarity of the surgical area during the intraoperative period and may cause problems with postoperative delays in discharge. In the present study, all patients were discharged as scheduled in accordance with the surgical discharging criteria. Although bleeding may have prolonged the duration of surgery, we noted no difference in the duration of surgery between the LAD and general anaesthesia groups. Ayoglu et al.8 demonstrated that, although dexmedetomidine reduced bleeding during septoplasty performed under general anaesthesia, it did not reduce the duration of surgery.
The recovery period was shorter in the LAD group than in the general anaesthesia group. In the general anaesthesia group, several factors during the postoperative period resulted in prolongation of the recovery period, including delayed ability to control nausea–vomiting, delayed ability to control pain and delayed improvement in unconsciousness and physical activity with respect to MAS. Alhashemi17 reported that, in cataract operations performed under local anaesthesia, sedation with dexmedetomidine resulted in cardiovascular depression and a delay in recovery. The absence of these problems in the LAD group in the present study may have been due to the low dose of dexmedetomidine. We suggest that reduced postoperative pain and need for analgesia in the LAD group was due to the effect of local anaesthesia. Sener et al.11 demonstrated that the need for lornoxicam and narcotics for the management of postoperative pain was reduced significantly only during septoplasties performed under general anaesthesia. In the present study, the need for postoperative pethidine in the general anaesthesia group was 90%, but only 16.6% in the LAD group.
Despite the antiemetic effect of propofol18,19 used in the general anaesthesia group, more nausea–vomiting was observed, probably due to opioids and volatile anaesthetics. In a retrospective study conducted by Fedok et al.,3 similar results of a shorter recovery period, reduced postoperative nausea–vomiting and reduced bleeding in the local anaesthesia group were observed, as in our study. One study has indicated that postoperative nausea–vomiting occurs more frequently in women.20 But in our study, 13 patients in the general anaesthesia group experienced nausea–vomiting (eight men and five women); in the LAD group, five patients experienced nausea–vomiting (three men and two women). So, there were no significant differences related to the number of women and men who experienced nausea–vomiting between the groups. Therefore, we do not consider that sex affects the incidence of nausea–vomiting. Intraoperative and postoperative total amount of bleeding were similar in both groups (1087 and 1260 ml in the general anaesthesia group, respectively; 667 and 610 ml in the LAD group, respectively); thus we can say that the postoperative nausea–vomiting did not have a significant effect on bleeding.
We believe that the reason patients preferred local anaesthesia when questioned 1 week after discharge was the effective intraoperative analgesia and sedation and the effective pain management, reduced nausea–vomiting and bleeding during the postoperative period.
Most of the patients in both groups also reported a better quality of breathing during the first postoperative week questioning. This similarity between the groups may have been due to the fact that only one surgeon performed all the surgical procedures. A similar shorter duration of surgery in both groups may have also contributed to reduced postoperative oedema, and, as a consequence, a higher quality of breathing. Also, we can say that both of the anaesthesia techniques showed the same effect (i.e. whether they affected tissue recovery, oedema) on quality of breathing in the early postoperative period.
Day-case surgery exhibits significant remarkable advantages for the patient, including less disruption to routine, reduced risk of nosocomial infection and shorter waiting times, and it is also associated with reduced hospital costs. Although there is a consensus that the patients undergoing myringotomy and tympanostomy tube insertion and direct endoscopies under local anaesthesia can be discharged on the same day as the surgery is carried out, there is still considerable controversy regarding the suitability of septal surgery for day surgery.21 This is directly related to the re-admission rates associated with day-case septoplasty. In the large majority of cases, re-admission was due to postoperative bleeding and patients undergoing general anaesthesia.3,5,21 In our study, although we observed less bleeding intraoperatively and postoperatively in the LAD group than in the general anaesthesia group, all patients were discharged on the following day. In our institute, because septoplasty operations have been performed under general anaesthesia until now, otorhinolaryngology clinicians do not want to discharge patients until the following day because of the risk of bleeding. But we observed that the patients undergoing septoplasty under local anaesthesia with dexmedetomidine could be discharged the same day owing to less bleeding and other advantages.
In the present study, we demonstrated that both techniques of anaesthesia may be safely employed during septoplasties; however, local anaesthesia with dexmedetomidine sedation resulted in less surgical bleeding, more effective postoperative pain management, together with a low incidence of nausea–vomiting, more stable haemodynamic state, a shorter recovery period and a higher level of satisfaction with anaesthesia. We conclude that these factors may lead to the choice of this anaesthetic technique during septoplasty.
This study was supported by grants provided by Baskent University Research Committee, Ankara, Turkey.
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