Laryngeal mask airway devices are a safe and effective method for anesthesia of laparoscopic extraperitoneal hernia repair surgery. A double blinded randomized prospective study.

doi:10.21203/rs.3.rs-2100173/v1

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Laryngeal mask airway devices are a safe and effective method for anesthesia of laparoscopic extraperitoneal hernia repair surgery. A double blinded randomized prospective study.

https://doi.org/10.21203/rs.3.rs-2100173/v1

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Background: Laparoscopic Total extraperitoneal hernia repair is widely used for the treatment of inguinal hernias all over the world. There are many studies in the literature showing advantages of the TEP method compared to open repair. Endotracheal intubation with general anesthesia is preferred in the TEP method. Sore throat, hoarseness, and pain in the early postoperative period may occur due to strain during removal of the endotracheal tube. We aimed to evaluate the efficacy and safety of using a laryngeal mask airway device (LMA) for general anesthesia in TEP surgery.

Materials and Methods: We evaluated the operative outcomes of 130 patients with inguinal hernias repaired by TEP in our hospital between May 2021 and October 2021. A total of 130 adult patients of American Society of Anesthesiologists physical status I, II, and II who underwent TEP surgery were randomly allocated to one of two groups: group A (LMA-TEP), in which the patient’s airway was secured with an appropriately sized LMA, and group B (ETT-TEP), in which the ETT was secured under laryngoscopy.

Results: There was no difference between the two groups in patient background, anatomical delineation satisfaction, surgery complications, hospital stay, or surgery time. The duration of anesthesia was significantly lower in the LMA group (p = 0.001). Although sore throats and dysphonia were less common in the LMA group, there was no statistically significant difference (p = 0.068 and p = 0.077, respectively). The 1st hour pain score was significantly lower in the LMA group (p = 0.019). There was no significant difference between the two groups in the postoperative 4th hour, 8th hour, 12th hour, and 24th hour pain scores.

Conclusion: The results of this study are the first to show that an LMA device can reduce postoperative complications associated with endotracheal intubation during general anesthesia in TEP surgery.

TEP

inguinal hernia

LMA device

ETT device

general anesthesia

Inguinal hernia repair is one of the most performed surgical operations worldwide. However, there is no common consensus on the most appropriate surgical technique. Laparoscopic surgery offers less postoperative pain, low wound infection rates, good cosmetic results, and a fast return to work compared to open surgery (1,2). Since the laparoscopic total extraperitoneal hernia repair (TEP) technique is performed in the extraperitoneal area, unlike the laparoscopic transabdominal preperitoneal repair (TAPP) technique, organ injuries and postoperative ileus cases are rare. The disadvantage of the TEP technique is that it is difficult due to the learning curve, and the results of the surgery depend on the experience of the surgeon (3). Surgeons who apply the TEP technique generally prefer general anesthesia because it provides complete muscle relaxation (4).

Despite advances in contemporary anesthesia management, airway management remains important to anesthesiologists. The endotracheal tube (ETT) was accepted as the gold standard to provide a safe glottic plug in laparoscopic procedures, especially under general anesthesia (5). Morbidities such as trauma to vocal cords and oral cavity structures, pressure response, and sore throat raise serious concerns about the use of ETT and require a better alternative (6). In recent years, supraglottic airway devices such as the LMA device have been preferred in both normal surgeries and procedures requiring difficult intubation, such as laparoscopic abdominal surgery (7). There are studies in the literature on the use of laryngeal masks in laparoscopic surgery (5–10). The use of LMA has some advantages over endotracheal intubation, such as quick and easy insertion, less neuromuscular blockade requirement, and a lower incidence of postoperative morbidity (5). In light of the results obtained in the studies, it is shown that the use of the LMA is associated with fewer bronchospasm, laryngospasm, cough, and sore throat than the tracheal tube since it is not placed in the trachea (7–10). Although there are studies in children in the literature on TEP surgery with the LMA method, there are no studies in adults (11). Significantly shorter surgery times and shorter anesthesia times have caused us to question the preference of ETT in adult patients (7–12). The aim of this prospective randomized study was to evaluate the efficacy, safety, and suitability of LMA in adult patients undergoing TEP for inguinal hernia.

This Double-Blind, Prospective, Randomized Clinical Trial was conducted after review and approval by the institutional local ethics committee. The study was registered on the clinical trial platform (NCT04788771) and the informed consent with written and verbal according to Helsinki Declaration were taken Patients who were diagnosed with uncomplicated inguinal hernia in our hospital between May 2020 and November 2021 were included in the study. A total of 130 patients, whose physical conditions were classified as American Society of Anesthesiologists I, II, and III, were randomized and assigned to the ETT-TEP and LMA-TEP groups determined for general anesthesia management.

Patients with chronic pulmonary disease, a high risk of difficult intubation (short neck, for example), gastroesophageal junction disease (hiatus hernia, gastroesophageal reflux disease, paraesophageal hernia, for example), and a body mass index greater than 35 kg/m2 were excluded from the study. Patients who are first anesthetized with the LMA device and need endotracheal intubation during the operation due to the concern that respiratory problems may develop were excluded from the study.

The demographic characteristics of the patients and surgical and postoperative results were reviewed by comparing the two groups. All operations were performed by a surgeon experienced in TEP and an experienced anesthesiologist. The duration of the operation, the length of hospital stays, the use of analgesia, and the complications during the follow-up were examined. After discharge from the hospital, the patients were followed up in the outpatient clinic at regular intervals. A blinded, trained observer collected the data during the study.

Postoperative analgesia (1000 mg intravenous acetaminophen) was given at the request of the patients. The patients were unaware of the type of LMA device. The primary outcome of the study was to compare the postoperative pain score between the two groups at immediately after surgery (1 hour after surgery). Pain was measured using a numeric rating scale (VAS scale) from 0 to 10, with "0" representing the absence of pain and "10" representing the worst pain imaginable. The level of pain was measured before surgery, 1 hours, 4 hours, 8 hours, 12 hours, and 24 hours after surgery (postoperative day 1; POD1), and 3 months later. The use of analgesia for 3 months or more due to pain after surgery was considered chronic pain. As the secondary results of the study, duration of anesthesia, pharyngolaryngeal complications of anesthesia methods such as sore throat, dysphonia, dysphagia, nausea and vomiting were evaluated.

After coming to the operating room, all patients were premedicated with 2 mg intravenous midazolam and standard monitoring (noninvasive assessment of blood pressure, oxygen saturation, pulse oximetry, electrocardiography) was performed. After preoxygenation, patients were induced with propofol 1-1.5 mg/kg, fentanyl 0.1–0.3 microgram/kg, and rocuronium 0.3–0.5 mg/kg. Upon the disappearance of the eyelash reflex, the same anesthesiologist applied chin thrust in a neutral head position. The patients were ventilated with a mask for 2 minutes using a Maquet anesthesia machine (Mequet, Sweden). Controlled ventilation was set to a tidal volume of 6 mL/kg, a frequency of 13 breaths per minute, and an inspiratory:expiratory ratio of 1:2. Relevant airway devices were then placed accordingly. The LMA cuff was inflated with air until no air leak was observed. Appropriate placement of the airway device was determined by chest expansion, continuous square wave capnogram, peak airway pressures (PAWs) of 20 cmH2O, and absence of audible oropharyngeal leak. The placement of the LMA device was evaluated by unimpeded inspiratory and expiratory flow testing(8). If any of the criteria for satisfactory ventilation were not met, the LMA device was manipulated by rotating the device in the sagittal plane until minimal resistance to bag ventilation was achieved. The patients were then mechanically ventilated with an anesthesia ventilator with a tidal volume of 6 ml/kg and a respiratory rate of 12/min and an inspiratory/expiratory ratio (I:E) of 1:2, and an end-tidal CO2(EtCO2) was also adjusted to retain its value approximately at 35–45 mmHg.

Anesthesia was maintained with desfloran 0.8-1 MAC and remifentanil 2–5 µg/kg•min − 1 according to blood pressure and heart rate during the operation. Extraperitoneal space pressure (ESP) was set to approximately 12 mmHg. At the end of the operation, anesthesia was stopped and the LMA or tracheal tube was removed when the patient was able to open his mouth on command. The cuff was deflated while the devices were being removed.

The trial technique of the randomization, blinding, surgical technique, and postoperative analgesia regimens were all the same as previously published in a trial of patients undergoing TEP[3].

Sample size calculation was based on pain scores in the study comparing patients' supraglottic airway and ETT in TAPP surgery. In the calculation, mean(s.d.) VAS scores for the SGA and ETT groups were used in the entire postoperative period. The pooled mean difference in pain ratio between the LMA and ETT groups at this time point was 0.65–0.82. It was assumed that both groups had a log-normal distribution in postoperative pain and therefore two sample formulas were used to calculate the sample size. A ratio of 0.75 (ETT/LMA) was considered a positive treatment effect and considered clinically significant. With a power of 0.9 and two-way α = 0.05, the required sample size was calculated as 37 per group. To increase the value of the study, 65 patients in both groups were included and randomized.

Statistical analysis

Descriptive statistics was used to present the demographic characteristics of the study population. Differences between these groups were tested using Pearson chi-square test or Fisher’s exact test for categorical variables, and one-way analysis of variance (ANOVA) for continuous variables. All analyses were performed using IBM SPSS Statistics version 22.0 (IBM Corp, Armonk, NY, USA). A p value < 0.05 was considered statistically significant.

The patient flowchart of this prospective randomized study is given in Fig. 1. 156 patients were screened for inclusion in the study, however 26 patients were excluded for various reasons (8 patients for being under 18 years of age, 12 for having (+) COVID-19 PCR test results, and 6 patients refused to participate in the study). The remaining 130 patients were randomized into LMA-GA and ETT-GA groups with 65 patients each. Three patients in the ETT group were excluded because of their prolonged use of NSAIDs for various reasons (e.g., headaches) and one patient in the LMA group because of the inability to securely insert the device.

One patient in each group was excluded from the study for not showing up for their outpatient follow-ups. The LMA device was considered appropriate once the exhaled tidal volume was 8 mL/kg and no oral air leakage was detected.Therefore, the LMA group consisted of 63 patients and the ETT group consisted of 61 patients (Fig. 1).

The demographic characteristics of the patients in our study are shown in Table 1. The mean age of the patients was 52.8 ± 13.39 years. There was no significant difference between the two groups in terms of the mean age of the patients (p = 0.687). While there was no significant difference between the two groups in terms of mean surgery time, the duration of anesthesia was statistically significantly higher in the ETT-GA group than in the LMA-GA group (p = 0.462, p < 0.001, respectively) (Table 2).

Table 1

Demographic characteristics of patients
	Group A ( ETT)	Group B ( LMA)	Total	P value
Cases (n)	61	63	124
Age (years) mean ± SD	53,2 ± 14,40	52,3 ± 12,43	52,8 ± 13,39	0.687
Gender ( M/F) (n)	59 / 2	60 / 3	119 / 5	0.675
BMI (kg/m2) mean ± SD	26 (± 2,904)	26 (± 2,753)	26 (± 2,818)	0.687
ASA (n) I II III	6 49 6	14 45 4	20 94 10	0.154
Site of lesion (n) (Unilateral/bilateral)	47 / 14	48 / 15		0.756
Type of hernia, EHS (n) L1 L2 L3 M1 M2 M3	12 23 8 6 8 1	9 23 8 10 7 2	21 46 16 16 15 3	0.903
Combined hernia (n)	6	7		0.876
Primary/recurrent hernia (n)	53 / 8	54 / 9	107 / 17	0.856
Notes: Data presented as mean ± SD. Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index; SD, standard deviation; ETT, Endotracheal entubation tube; LMA, laryngeal mask airway; EHS, groin hernia for classifications of the European Hernia Society

Table 2

Operative outcomes
	Group A ( ETT )	Group B ( LMA )	Total	P value
Surgery Time (min) ( mean ± SD )	49,6 ± 15,706	50,5 ± 12,528	48,9 ± 15,292	0.462
Anesthesia Time (min) ( mean ± SD )	66,6 ± 16,147	55,9 ± 13,719	61,1 ± 15,845	0.001
Insuflation Time (min) ( mean ± SD )	36,7 ± 13,307	39,2 ± 14,669	38,4 ± 14,612	0.280
Hospital stay (days) ( mean ± SD )	1,1 ± 0,386	1 ± 0,177	1,1 ± 0,302	0.074
Intraoperative complications	0	0	0	N/A
Postoperative complications ( n ) (%) Recurrence Seroma Scrotal edema Port site infection	1 (1,7%) 6 (9.83%) 8 (13,11%) 1 (1,7%)	1 (1,6%) 7 (11.11%) 8 (12.69%) 1 (1,6%)	2 (1,6%) 2 (10.48%) 16(12.90%) 2 (1,6%)	0.972 0.876 0.530 0.972
Conversion (n) Lichteinstein TAPP	2 1 1	2 1 1	4 2 2	0.981
3.month pain	0,3 ± 0,57	0,3 ± 0,58	0,3 ± 0,58	0.924
Notes: Data presented as mean ± SD. Bold indicates significance. Abbreviations: SD, Standard deviation; ETT, Endotracheal entubation tube; LMA, laryngeal mask airway; TAPP, Transabdominal preperitoneal repair

Extraperitoneal space dissection was performed with a balloon dissector device, and sufficient space was created in all patients in both groups. The anatomical appearance of the inguinal region was adequate in 96.8% of the patients. Two patients (p = 0.896) in both groups had insufficient space due to the closure of the extraperitoneal space because of a large peritoneal tear developed during hernia dissection(Table 3).

Table 3

Intraoperative problems in surgical technique
	Group A (ETT)	Group B (LMA)	Total	P value
Dissection of extraperitoneal space: easy (n)(%)	61 (100)	63 (100)	124 (100)	1.000
Anatomical delineation: satisfactory (n)(%)	59 (96.7%)	61 (96.8%)	120 (96.8)	0.444

Postoperative pain score at 1 h in Group A was 4.9 ± 1.96 and in Group B 4.1 ± 1.93 (Table 4) The difference between these two groups was statistically highly significant (P = 0.019). There was no significant difference between the two groups in terms of preoperative pain score (p = 0.730). There was no significant difference between the two groups in terms of pain scores at the 4th hour, 8th hour, 12th hour and 24th hour postoperatively.

Table 4

Patients pain scoring (VAS)
	Group A ( ETT )(n:61)	Group B ( LMA )(n:63)	Total (n:124)	P value
Preop VAS	0,4 ± 0,784	0,3 ± 0,563	0,4 ± 0,68	0.730
Postop 1 VAS	4,9 ± 1,96	4,1 ± 1,93	4,5 ± 1,99	0.019
Postop 4 VAS	4,5 ± 1,91	4,3 ± 1,86	4,4 ± 1,88	0.790
Postop 8 VAS	3,6 ± 1,84	3,1 ± 1,36	3,4 ± 1,63	0.138
Postop 12 VAS	2,6 ± 1,50	2,5 ± 1,61	2,5 ± 1,55	0.405
Postop 24 VAS	1,6 ± 0,82	1,6 ± 0,96	1,6 ± 0,89	0.473
Notes: Data presented as mean ± SD. Bold indicates significance. Abbreviations: SD, standard deviation; ETT, Endotracheal entubation tube; LMA, laryngeal mask airway; VAS, visual analogue scale

Table 5

Adverse effects
	Group A ( ETT ) (n:61)	Group B ( LMA ) (n:63)	P value
Sore Throat	13 ( 21.3% )	6 ( 9.5% )	0.068
Hoarsaness and Dysphonia	10 ( 1.4% )	4 ( 6.3% )	0.077
Dysphagia	4 ( 6.6% )	1 ( 1.6% )	0.160
Nausea	1 ( 1.7% )	0 ( 0 % )	0.304
Vomiting	0 ( 0% )	0 ( 0% )	N / A
Notes: Data presented as mean ± SD. Abbreviations: SD, standard deviation; ETT, Endotracheal entubation tube; LMA, laryngeal mask airway

There was no difference between the two groups in terms of dysphagia, nausea, and vomiting, which are complications related to anesthesia management (Table 4). Although sore throats and dysphonia were more common in the ETT group, no significant difference was found (p < 0.067, p < 0.077). No serious postoperative complications of reflux aspiration were observed in any of the two patient groups.

It has been reported that GA is preferred because it provides full analgesia during laparoscopic hernia operations, the curve of "learning" and "teaching" is easier, and because of the patients' fear of "pins and needles in the waist", "complete unconsciousness" is preferred by the patients[13]. It has been reported that increased intra-abdominal pressure due to the carboperitoneum created in laparoscopic surgery adversely affects lung mechanics during surgery[14]. In laparoscopic abdominal surgeries, ETT-GA is considered the ideal anesthesia method as it provides adequate ventilation and provides a barrier against lung aspiration even in the presence of increased intra-abdominal pressure due to carboperitoneum. However, endobronchial intubation is not uncommon, and ETT-GA may not be successful in difficult intubation situations[5–10]. LMA can overcome these problems even in obese patients undergoing laparoscopic abdominal surgery, trendelenburg position, and difficult airway conditions [15]. Although the LMA device could not be fixed properly in one patient in our study, no aspiration or respiratory problems were observed. Similar rates were found compared to other studies in the literature[15–17]. Although ETT-GA is preferred as the ideal anesthesia method for endoscopic surgery, coughing and retching due to irritation may occur during the removal of the intubation tube after surgery. This causes pain in the operation area due to increased intra-abdominal pressure[15]. We use the LMA device to minimize this problem. The LMA device is an effective, safe, and easy-to-apply device for the TEP technique and is comparable to the ETT.

Since the TEP technique is performed in the extraperitoneal area, muscle relaxation must be provided very effectively. Therefore, general anesthesia with ETT is preferred by surgeons who perform the TEP technique. With LMA, very good muscle relaxation can be achieved with general anesthesia. There are many studies in the literature regarding the use of LMA in laparoscopic abdominal surgeries[5–10]. While there are studies on the use of LMA in inguinal hernias in children[11, 12], there is only one study on the TAPP technique in adults[15]. There is no LMA study on the TEP technique in the literature. In our study, we compared extraperitoneal space creation, ease of dissection technique, and anatomical description of the structures in the inguinal region for two different anesthesia management techniques. The surgeon graded the dissection method and field opening at the end of the operation, and all repairs were performed by the same surgeon. As graded by the surgeon (p = 1.000, p = 0.444), there was no difference in any of the above-mentioned parameters between the two groups, as graded by the surgeon (p = 1.000, p = 0.444). There are no published studies comparing these parameters between the two groups.

Seroma and scrotal edema are common postoperative complications after TEP surgery[18–21]. Since they simulate recurrence in the postoperative period, they pose a serious problem for both the surgeon and the patient. The incidence of seroma after TEP repairs has been reported to be between 1.13% and 11% (15.20–26) and the incidence of scrotal edema between 1% and 17.8%[20–27]. Lau et al. [26] stated that seroma and scrotal edema were caused by advanced age, large hernia defects, inguinoscrotal hernias, and the presence of a distal indirect sac. In their study, they reported that excessive cord dissection, hernia sac and prolonged operation time may also be causes of seroma and scrotal edema. In our clinical study, seroma occurred in 7 patients (11.11%) in the LMA-TEP group and in 6 patients (9.83%) in the ETT-TEP group, while scrotal edema was observed in 8 patients (13.1%) in the ETT-TEP group and in 8 patients (12%, in the LMA-TEP group), but no statistically significant difference was detected between the two groups (p: 0.876, p: 0.530 respectively).

The most common complaint after hernia surgery is pain[18, 28]. In their study to determine the causes of acute pain after TEP, Lau et al. [28] discovered that pain was worse in younger (65-year-old) female patients and in female patients with unilateral hernias. In this study, they reported that unilateral or bilateral hernias, seroma development, hernia types, primary or recurrent hernia, and duration of surgery were not effective in relieving pain. In this study, age and gender were determined as independent effective factors in terms of pain scores. Although ETT is accepted as the gold standard for laparoscopic inguinal hernia surgeries, there is always pain in the port areas in the early postoperative period due to the increase in intra-abdominal pressure due to straining and coughing during removal of the tube after surgery[23–29]. Since these problems will be much less with the use of LMA, we prefer to use it to reduce post-operative pain. Nagahisa et al. reported in a prospective randomized study that the use of supraglottic airway in TAP surgeries significantly reduced pain in the early postoperative period[15]. In our study, there was no statistically significant difference between the two groups in the 4th, 8th, 12th, and 24th hour VAS pain scores. However, the VAS score at 1 hour was significantly higher in the ETT-GA group than in the LMA-TEP group (4.9 vs. 4.1, p = 0.019). We think that this patient's ETT device was important because it caused pain in the operation area due to increased abdominal pressure due to retching and straining after removal. At the 3rd month, there was no difference between the groups in the pain assessment. There are studies in the literature showing that preoperative pain plays an active role in postoperative pain.[29, 30]. However, when the groups are randomized, hernia types and hernia defect diameters may not be significant in terms of preoperative pain since they are equally distributed. Since the groups were randomized in our study, there was no difference in preoperative pain values between the groups (p = 0.730). If we avoid pain-triggering movements after the surgery, patients may experience less pain and faster recovery in the early period. We want to perform TEP surgery for inguinal hernia without experiencing any pain and anxiety. TEP surgeries performed using LMA are an appropriate treatment approach in the treatment of young patients and patients with low pain threshold. The reduction in post-operative pain ensures that patients are more comfortable when they are discharged. In general, the TEP technique provides economic benefits for the society as it provides an earlier return to work, while the use of LMA further increases this advantage.The conversion rate of the TEP technique has been reported to be between 0 and 10.6% in different studies[1, 2, 18–22, 27].

There is no data in the literature comparing the duration of surgery and duration of anesthesia between the two groups in adults. While there was no difference in the duration of surgery between the groups in two studies in which laparoscopic inguinal hernia surgery was performed on children, the duration of anesthesia was found to be significantly higher in the ETT group[11, 12]. It has been reported that there was no difference in the duration of surgery and anesthesia between the LMA and ETT groups when performed with the TAPP technique in adults[15]. In studies of laparoscopic surgeries in which LMA and ETT were compared, no difference was found in surgical times, while anesthesia times were found to be statistically significantly longer in the ETT group[31, 32]. In their prospective randomized clinical study, Ye et al. reported that no significant difference was found between the LMA and ETT groups in terms of anesthesia duration[33]. In our study, no statistically significant difference was found between the two groups in terms of the duration of surgery (p = 0.462). It was determined that the ETT-TEP group had a significantly longer duration of anesthesia than the LMA-TEP group (66.6 ± 16.14 vs 55.9 ± 13.71, p 0.001).

ETT is accepted as the ideal anesthesia method to avoid the risk of aspiration in general anesthesia. Even so, the LMA device's ease of use and lower risk of pharyngolaryngeal complications are big advantages[34, 35]. While pharyngolaryngeal complications have been reported between 0% and 20% for LMA in laparoscopic abdominal surgeries, this rate varies between 0% and 47% for ETT[7–10, 34]. Ozbilgin et al., in their randomized clinical study, found that sore throat, dysphonia, and dysphagia were statistically significantly higher in the ETT group than in the LMA group[34]. Similarly, in their randomized clinical study, Ye et al. discovered that sore throat and dysphonia were statistically significantly higher in the ETT group than in the LMA group[33]. Saraswat et al., in a prospective randomized study, reported that there was no significant difference between the two groups in terms of sore throat, dysphonia, and dysphagia[35]. In our study, sore throat, dysphonia, and dysphagia were found to be higher in the ETT group than in the LMA group, but they were not found to be statistically significant (p: 0.068, p: 0.077, p: 0.393).

There is a concern that SGA devices may not reliably protect the lungs from gastric contents[36]. In laparoscopic abdominal surgeries, the carboperitoneum causes an increase in intra-abdominal pressure, which theoretically increases the gastric air content. This raises concerns about the risk of aspiration. However, a study reporting that the LMA device can act as a plug at the level of the upper esophageal sphincter if positioned correctly has dismissed this concern[37]. Nausea and vomiting are undesirable side effects of anesthesia that can be seen after laparoscopic surgery. In their study, Ye et al. found no significant difference in nausea and vomiting in the LMA and ETT groups[33]. In Kang et al.'s randomized clinical study, they reported that while vomiting was not detected in any case, nausea was detected at high levels in the ETT group, but it was not statistically significant [38]. In recent studies, 2nd generation pre seal laryngeal masks were shown to be superior during laparoscopic abdominal surgeries due to concernes about gastric aspiration risk[33–35]. It is an important advantage that gastric problems caused by increased intra-abdominal pressure do not appear in the TEP technique since it is performed in the extraperitoneal area and no intra-abdominal pneumoperitoneum is needed. In adition, TEP surgery does not require deep sedation and surgery is done in supine position and does not require trendelenburg positioning. In our study, we used conventional laryngeal masks over 2nd generation pro-seal masks due to their increased cost. Nausea was detected in only 1 patient in the ETT group, and vomiting was not observed in any patient. This can be explained by the absence of gastric complaints due to the absence of intra-abdominal insufflation in the TEP technique.

In the light of the data obtained in our study, in terms of postoperative pain scoring, which is the primary endpoint, the 30th minute VAS scores in the LMA group were found to be significantly lower than in the ETT group. Sore throat and dysphonia, which were the secondary endpoints of the study, were less common in the LMA group than in the ETT group. In the light of these results, we recommend LMA anesthesia method in the surgical treatment of inguinal hernia with TEP technique.

One of our limitations is that our study was conducted in a single center by a single surgeon and anesthesiologist. Therefore, multicenter randomized clinical trials are needed. We only used one type of LMA device. Supraglottic airway devices have developed a lot in recent years, and studies should be conducted with different models.

We concluded that postoperative pain and anesthesia time are lower in patients with the LMA device in the treatment of inguinal hernia with the TEP technique compared to ETT. In addition, pharyngolaryngeal complications were less common in the LMA group. Therefore, LMA may be preferred as an alternative to endotracheal intubation for the TEP technique.

Conflicts of interest: The authors declare that they have no conflict of interest

Funding: No

Authors’ Contributions:

Study conception and design: Turgut Donmez, Mehmet Karabulut

Acquisition of data: Sezer Bulut, Eyup Gemici, Ahmet Surek

Analysis and interpretation of data: Sina Ferahman, Nuri Alper Sahbaz, Nilsu Onur Damla

Drafting of manuscript: Engin Hatipoglu, Turgut Donmez, Husnu Aydin

Critical revision of manuscript: Nalan Saygı Emir, Nuri Alper Sahbaz, Mehmet Karabulut

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No competing interests reported.

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Laryngeal mask airway devices are a safe and effective method for anesthesia of laparoscopic extraperitoneal hernia repair surgery. A double blinded randomized prospective study.

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