AuraGainTM and i-Gel laryngeal masks in general anesthesia for laparoscopic cholecystectomy Performance characteristics and effects on hemodynamics

يسفنتلا ءاوهلا ىرجم ةزهجأ ءادآ ةنراقمو مييقت :فادهلأا صخي اميف يماغرلا بيبنتلا يف ةمدختسلما رامزلما قوف ةديدلجا ىلع اهرثأو ،ةيحارلجا ةيلمعلا دعب تافعاضلما ،همادختسا ةلوهس لاصئتسا يف ءاوهلا ىرجم طغض ةورذو ةيومدلا ةرودلا تارشؤم .راظنلماب ةرارلما مهتلاح تفنص ضيرم 114 ىلع ةساردلا تلمتشا :ةقيرطلا راظنلماب ةرارملل يرايتخا لاصئتسا مهل ةررقلما ASA 1-2 ةيحصلا ةساردلا تلمتكا دقو .ةمظتنلما ةيئاوشعلا ةنراقلما ةبرتج يف اوجرداو نامايدأ ىفشتسم يف م2017 ريانيو م2016 رياني نم ةرتفلا للاخ ةادأ ةعومجم ىضرلما ميسقت تم .ايكرت ،نامايدأ ،ميلعتلاو ثوحبلل ةعومجمو ®i-Gel ةادأ ةعومجمو ،)38=ددعلا( AuraGainTM طغض ،مادختسلإا ةلوهس نم لك ةنراقبم انمق .Intersurgical ةادأ .ةيومدلا ةرودلا تاريغتمو ،تافعاضلماو ،ءاوهلا ةلوهس تناك .ضيرم 105 عم ةبرجتلا نم ءاهتنلاا تم :جئاتنلا ،جاردلإا ءارجإ ةدم عم اهمييقت تم يتلا SADs ل جاردلإا موعلبلا برست طغضو ،يلولأا لاخدلإا حانج تلادعمو ،تلاوالمحاو يطاسبنلاا طغضلاو ،بلقلا تابرض لدعم ناك .تاعومجلما ينب ام AuraGain تاعومجم يف ريثكب لقأ ءاوهلا ىرجم ةورذو ،ينايرشلا .ETT ،p<0.017 عم ةنراقلماب ، ®i-Gel و عم ةنراقملل لباق i-Gel® SADs و AuraGain نم لك :ةتمالخا ،LC ل ماعلا ريدختلا يف ءاوهلا ىرجم يف مكحتلل مدختسلما ETT امنيب .ةحارلجاب ةطيلمحا تافعاضلماو قيبطتلا ةلوهسب قلعتي اميف i-Gel® SADs و AuraGain نم لكل ةيومدلا ةرودلا ةباجتسا .ETT نم لضفأ Objectives: To evaluate and compare the performances of new types of supraglottic airway devices (SADs) with endotracheal intubation regarding their ease of insertions, perioperative complications, and effects on hemodynamic parameters and peak airway pressures in laparascopic cholecystectomy (LC). Methods: One hundred and fourteen patients with ASA 1-2 physical status scheduled for elective LC were Original Articles recruited for this prospective randomized controlled trial. The study was completed between January 2016 and January 2017 in Adiyaman University Research and Educational Hospital, Adiyaman, Turkey. The patients were divided into AuraGainTM (Ambu, Ballerup, Denmark) (n=38), i-Gel® (Intersurgical Ltd, UK) (n=35), and endotracheal tube (ETT)(n=32) groups. Ease of insertion, airway pressures, complications, and hemodynamic variables were compared. Results: The trial was completed with 105 patients. Ease of insertion for SADs which was evaluated with insertion procedure duration, attempts, first insertion success rates, and oropharyngeal leak pressures were similar between the groups. Heart rate, systolic and diastolic arterial pressures, and peak airway pressures were significantly lower in the AuraGain and i-Gel® groups, compared with the ETT, p<0.017. Conclusion: Both AuraGain and i-Gel® SADs are comparable with ETT used for airway control in general anesthesia for LC, regarding application ease and perioperative complications. Favorable hemodynamic responses to AuraGain and i-Gel® SADs may put them in a better place than ETT. Saudi Med J 2018; Vol. 39 (11): 1082-1089 doi:10.15537/smj.2018.11.22346 From the Department of Anesthesiology and Reanimation (Sabuncu, Demir), Yuksek Ihtisas Research and Educational Hospital, Health Sciences University, Ankara, from the Department of Anesthesiology and Reanimation (Kusderci, Oterkus, Abdullayev, Uludag), and from the Department of General Surgery (Ozdas, Goksu), Adiyaman University Research and Educational Hospital, Adiyaman, Turkey. Received 6th May 2018. Accepted 26th September 2018. Address correspondence and reprint request to: Dr. Ulku Sabuncu, Department of Anesthesiology and Reanimation, Yuksek Ihtisas Research and Educational Hospital, Health Sciences University, Ankara, Turkey. E-mail: sabuncuulku@gmail.com ORCID ID: orcid.org/0000-0003-3655-3366 OPEN ACCESS 1082 Saudi Med J 2018; Vol. 39 (11) www.smj.org.sa 1083 www.smj.org.sa Saudi Med J 2018; Vol. 39 (11) AuraGain and I-Gel for laparoscopic surgery ... Sabuncu et al T most preferred anesthetic technique in laparoscopic cholecystectomy (LC) is general anesthesia with controlled ventilation, most often via endotracheal tube (ETT). However, during the procedure, high intra-abdominal pressures due to carbon dioxide insufflation may increase the risk of passive gastroesophageal regurgitation and carbon dioxide retention. For these reasons, cuffed ETT is the most preferred technique when considered in terms of safety.1 The laryngeal mask airway (LMA) is a supraglottic airway device (SAD) developed by Dr Archie Brain, a British anesthesiologist, and it has been in clinical use since 1988. It is used as a convenient alternative to ETT, with easy and atraumatic insertion, as well as minimal somatic and autonomic responses in many clinical conditions.2 However, SADs have some disadvantages, like limited protection of the airway from gastric contents.2 The second generation SADs can overcome this issue. One of these is the i-Gel® (Intersurgical Ltd., UK), which is made of medical grade thermoplastic elastomer (styrene ethylenebutadiene styrene) and does not require an inflating cuff. Its design provides a perilaryngeal seal without cuff inflation. In addition, it is easily and rapidly placed, with a reduced risk of pharyngeal tissue compression. Moreover, it has a gastric drainage tube, and it allows the insertion of a gastric tube (maximum 14 Fr) and aspiration of the gastric contents and air. The third-generation SAD is the AuraGainTM (Ambu, Ballerup, Denmark), which has an anatomically curved design. Its design allows a rapid establishment of a safe airway. It also has a gastric drainage tube with a low frictional inner surface; thus, making placement of the tube easier (maximum recommended gastric tube is 14 to 16 Fr). There have been studies that investigated the performances of ProSealTM LMA (Intavent Orthofix, Maidenhead, UK) in LC.3,4 However, the performances of i-Gel® and AuraGain have not yet been sufficiently investigated. This study aims to evaluate the performances of new types of SADs (AuraGain and i-Gel®) with endotracheal intubation and compare their ease of insertion, airway pressures, and perioperative complications with ETT. In addition, the secondary aim of the study is to characterise their effects on hemodynamic parameters and peak airway pressures. Methods. Approval for this study was received from the Local Ethics Committee (Inonu University Clinical Research Ethics Committee, Malatya; protocol number 2015/178). Following the ClinicalTrials. gov registration with number NCT02925598 and according to the ethical standards of the Declaration of Helsinki, 114 patients with American Society of Anesthesiologists (ASA) 1-2 physical status scheduled for elective LC were recruited for this prospective randomized controlled trial. The closed envelope method was used for the patient assignment, and patients were divided into 3 groups by a blind anesthesia specialist in the premedication unit, namely the AuraGain, i-Gel®, and ETT groups, each with 38 patients. The airway management was determined by a sealed envelope, and the anesthetist in the operating room opened the envelope in which the airway device was determined. Patients who were under the age of 18 or had a history of hiatus hernia, gastroesophageal reflux, body mass index (BMI) >30 kg m–2 or ASA physical status 3 or over and patients who met the difficult intubation criteria were excluded from the study. Written informed consent was obtained from each patient. All the patients were blinded and premedicated with intravenous (IV) metoclopramide (anti-nausea 10 mg, Onfarma Medical, Samsun, Turkey) and ranitidine (Ulcuran 50 mg, Yavuz Medical,Istanbul, Turkey) 30 minutes prior to the surgical procedure. An 8-hour fasting period was ensured for the patients. Monitoring was carried out routinely by electrocardiography (ECG), pulse oximetry (peripheral oxygen saturation, SpO2) and non-invasive blood pressure (NIBP). A Datex-Ohmeda S/5 Avance (General Electric Inc, Madison, WI, USA) was used. Forehead temperature probes were employed to evaluate the patients’ temperature. Following the provision of a safe and effective airway, SADs and ETTs were connected to the breathing system (Primus, Drager, Lubek, Germany). The same anesthesia machine was used to evaluate lung mechanics. Oropharyngeal leak pressures (OLPs) were evaluated by a fixed gas flow of 4 L min-1 and closing the circuit’s adjustable pressure limiting (APL) valve 5 mins after the airway was secured. Then, the highest anesthesia circuit pressure at which the leak around the seal of the SADs had developed was noted and defined as OLP. Throughout the operation, fluid convection heating pads on table tops and air convection heating above the patients were used to maintain the body temperature at 36-36.5°C. Anesthesia was induced with propofol (Propofol 1%, Fresenius® Fresenius Kabi Medicine, Istanbul, Turkey; 2 mg kg-1), fentanyl (Fentanyl 0.05 mg/ml, Johnson and Johnson Disclosure. Authors have no conflict of interests, and the work was not supported or funded by any drug company.