Comparison of I-gel and LMA Supreme Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery
Phase: NA
Conditions: Airway Morbidity, Anaesthesia
Sponsor: Dokuz Eylul University

Cover Page 
Brief Title: I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery  
Official Title: Comparison of I-gel and LMA Supreme Without Neuromuscular Blocker in 
Laparoscopic Gynecological Surgery  
NCT02923427 
 
Date of Document: 12/21/2017 
  
       
 
  
 
 
 

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RESEARCH PROTOCOL 
Brief Title: I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery  
Official Title: Comparison of I-gel and LMA Supreme Without Neuromuscular Blocker in 
Laparoscopic Gynecological Surgery  
INTRODUCTION  
Since supraglottic airway devices entered clinical practice in 1988 they have gained common popularity 
in anesthesia administration. Initially only entering use as an alternative to the face mask, additional new 
modifications have currently allowed them to enter the field of use of the endotracheal tube (ETT). A 
significant advantage of supraglottic airway devices is that they allow the possibility of securing the 
airway in cases with difficult ventilation for both tracheal intubation and mask. Additionally, the lack of 
neuromuscular blocker agent (NBA) requirement provides advantages leading to common use such as 
use in many outpatient surgical interventions and causing less stress response compared to endotracheal 
intubation, (1-5).  
Initially the i-gel was produced in 2007 as a single-use supraglottic airway device. It includes a soft, gel-
like, non-inflatable thermoelastic elastomer cuff, a flattened expanded stem and hard biting block. The 
biting block acts as a buccal stabilizer preventing axial rotation and sliding out of position. There is an 
esophagus ventilation channel allowing the passage of a gastric tube (8) (Figure 1).  
The LMA-Supreme has similar characteristics to the i-gel. It has an esophagus ventilation channel 
allowing passage of a gastric tube and allows endotracheal intubation. Different to the i-gel it has an 
anatomic angle (Figures 2 and 3). The AuraGain is the only supraglottic airway device including a gastric 
channel, allowing endotracheal intubation and with an anatomic angle.  
Many studies have found the i-gel is easily and reliably inserted, provides sufficient ventilation and is 
related to low morbidity rates (8). As a result during positive-pressure ventilation, it may be used as an 
alternative to endotracheal intubation.  
Use of supraglottic airway devices in laparoscopic interventions   
 

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Contrary to the commonly held view, the use of supraglottic airway devices in gynecological laparoscopy 
does not increase the risk of pulmonary aspiration and ventilation failure (10,11,12). SGAD’s are 
recommended as alternatives to ETT for spontaneous respiration and positive-pressure ventilation 
(13,36,37). Laryngeal mask application has gained popularity for gynecological laparoscopic procedures 
in the United Kingdom (12,14). Additionally many previous studies have shown that LM can be 
successfully used to ensure appropriate pulmonary ventilation in laparoscopic surgical interventions 
(12,14,15). Verghese and Brimacombe did not encounter pulmonary aspiration in 1469 elective 
gynecology cases (16), while Malins and Cooper did not encounter it in 3000 patients (17). Bapate et al. 
(14) researched the incidence of regurgitation in 100 patients undergoing LM elective gynecological 
laparoscopy surgery. This study confirmed that the incidence of regurgitation during laparoscopy with 
LM was very low and supported the view that LM can be reliably used during elective laparoscopy 
surgery.  
Miller et al. (18) compared the use of ETT, LM-P and SLIPA during laparoscopic gynecology 
interventions and identified advantages of LMA use. The most important of these advantages is that 
insertion and use of supraglottic laryngeal devices for laparoscopic surgeries does not require 
neuromuscular blocker agents (NBA), contrary to tracheal tube technique. Thus, for outpatient 
laparoscopic surgeries they indicated that supraglottic laryngeal devices may be easily inserted without 
requiring muscle relaxants and reduce the duration spent in the operating room compared to ETT 
technique. Additionally the same study stated that there was less systolic blood pressure response and 
later less throat pain observed compared to ETT technique (18).  
Thomas et al. (19) showed that administering NBA did not change incidence of throat pain difficulty 
swallowing, and voice loss when a supraglottic airway device was used during positive pressure 
ventilation and again they reported that neuromuscular blockage did not affect success rates for LMA 
insertion and ease of insertion. Successful airway opening and surgical procedures have been shown to 
be possible without using NBA in a variety of studies (with ETT or LM) in the literature (20,21). This 
technique is a successful alternative when NBA are contraindicated or unwanted. In routine practice many 
clinics do not use NBA unless clinically indicated (22). Especially for interventions where LM is used, 
the use of NBA, which are not necessary for LM insertion, can be avoided. Gynecological laparoscopic 
interventions are appropriate for this. As a result one of the advantages of supraglottic airway device use 
in laparoscopic gynecological interventions may be listed as not requiring NBA. 3  
 

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Williams et al. (23) compared gynecological laparoscopic interventions in an LM group without NBA 
and an ETT group with NBA. The CO2 insufflation volumes and pneumoperitoneum formation durations 
in both groups were similar. The researchers emphasized that due to the advantages, total 
anesthesia/surgery duration in the LM group without NBA was shorter and this was the main output of 
the study.  
However in our literature search, we did not encounter any clinical study comparing the i-gel and LMS 
for laparoscopic interventions without NBA. There is a cadaver study comparing anatomic position and 
performance of i-gel, Ambu AuroGain and Laryngeal mask airway Supreme (LMA-Supreme) insertion. 
This study found that insertion of the Ambu AuroGain required manoeuvres, however the airway leak 
pressure was similar to other LMA-Supreme, and the nasogastric tube transfer was similar to LMA-
Supreme (38).  
There are studies comparing a variety of supraglottic airway devices with each other for laparoscopic 
gynecological surgeries. However, in all these studies neuromuscular blocker agents were used.  
Many anesthetists choose not to use neuromuscular blocker agents unless necessary for surgical 
procedures in routine application. As the clinical view is generally based on personal experience, the use 
of both neuromuscular agents and the dose management of these agents may vary between clinicians.31 
As a result making any specific recommendation is difficult. Chassard et al. evaluated 50 patients 
undergoing laparoscopic gynecological surgery with TIVA anesthesia management. In this study patients 
were divided into 2 groups as those given neuromuscular blocker agent (atracurium) and those not given 
it. In terms of operation conditions, an evaluation by surgeons found no difference between the two 
groups (32). The use of neuromuscular blockers in gynecological laparoscopy was found not to affect the 
majority of hemodynamic and respiratory changes due to pneumoperitoneum or operation conditions (33, 
34).  
Chen et al. (35) in a broad-series laparoscopic gynecological study (n=120) used ProSeal™ as SGAD 
and administered neuromuscular blocker agents to half of patients (rocuronium). The results of this study 
showed that both ventilation and surgical conditions were the same in both groups. The authors 
additionally noted that the use of neuromuscular blockers in laparoscopic gynecological surgeries was 
not beneficial as they did not reduce the operation and recovery times. In this study they emphasized the 
important point of easy insertion of laryngeal mask without neuromuscular blockers. Another study 
questioning the use of neuromuscular blockers in laparoscopic gynecological surgeries was completed 
by Swann et al.12. This study administered inhalation anesthesia for maintenance. The patients were 
divided into 2 groups. While spontaneous respiration and ventilation were ensured together without using 
neuromuscular blocker agents in the group with laryngeal mask inserted, controlled ventilation was 

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applied to the group with endotracheal intubation administered atracurium. There was no significant 
difference found between the groups in terms of intraoperative conditions; however a limitation of this 
study is the very short mean surgical duration (average < 15 min).  
Williams et al. (23) compared an LM group without NBA and an ETT group with NBA for gynecological 
laparoscopic interventions. The CO2 insufflation volumes and pneumoperitoneum formation durations 
were similar in both groups. The researchers emphasized that the main outcome of the study was the 
shorter total anesthesia/surgical duration in the LM group due to the advantage of not using NBA.  
However, there are some special situations where the use of neuromuscular blockers is definitely required 
for laparoscopic surgeries. Routine abdominal laparoscopy anesthesia is one of these special cases. In 
robotic surgeries extreme or deep neuromuscular blockage improves operation conditions and patient 
results (30).  
In our literature scan of studies researching the oropharyngeal leak pressures, ventilation parameters and 
especially mean airway pressure values in anesthesia for laparoscopic gynecological surgery including 
lower pelvic region without the use of neuromuscular blocker agents, we did not encounter a study 
comparing i-gel with LMA-Supreme.  
AIM  
To compare the effects of i-gel and LMA-Supreme on ventilation parameters and surgical view during 
laparoscopic gynecological surgery in cases administered positive pressure ventilation without the use of 
neuromuscular agents.  
MATERIAL AND METHOD  
This study will be completed after receiving permission from "Dokuz Eylül University Faculty of 
Medicine Clinical Research Ethics Committee” and “Medical Device Study and Authorization 
Coordination Department”, (Protocol No: 266-SBKAEK) with informed patient consent, as a 
prospective, randomized and double-blind study of 102 patients in ASA classification group I-II, aged 
from 18 to 65 years undergoing elective laparoscopic gynecological surgery.  
 

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Patients will be divided as  
Group 1 => i-gel (51 patients) (control group)  
Group 2 => LMA-Supreme (51 patients) (experiment group).  
Patients and surgeons performing the operations will not be aware of the airway device used. Patients in 
the groups will be determined with the block randomization method. By looking at a simple random 
number table, 102 individuals will be divided into 2 groups of 51 by using 6 blocks of groups containing.  
Before anesthesia induction patients taken to the operating room will have standard monitoring applied 
(non-invasive blood pressure measurements, electrocardiogram, peripheral oxygen saturation 
measurements). For preoperative sedation 0.02 mg/kg midazolam IV will be administered. Patients will 
be preoxygenized for 3 minutes with 6 L/min oxygen through a face mask. For anesthesia induction after 
2 minutes of 0.2 μ/kg/min remifentanil and 6 mg kg st-1 propofol infusion, IV 1-2 mg kg-1 propofol will 
be administered. After induction patients will be ventilated with a face mask with 6 L/min 100% oxygen.  
All patients will have bispectral index monitoring (BIS, ASPECT A-2000 BIS XP monitor) to standardize 
anesthesia depth. BIS values will be held between 40-60. BIS values will be kept within this interval by 
increasing or decreasing propofol infusion by 1 mg/kg after additional bolus dose of proprofol (1 mg/kg).  
Airway device insertion will be performed by two researchers with more than 5 years experience.  
During airway device insertion, if necessary depending on patient reaction additional doses of 0.5 mg/kg 
propofol will be administered.  
Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 μ kg/min-1 remifentanil and 50-150 
μ kg/ min-1 (4-10 mg/kg/hr) propofol IV infusion (29).  
Before inserting the LMA-Supreme and i-gel, water-based K-YTM (Johnson & Johnson Ltd. 
Maidenhead, UK) gel, not containing local anesthetic material, will be spread on surfaces that will come 
in contact with the palate. Depending on body weight of patients LMA-Supreme numbered as follows 
will be inserted:  
for < 50 kg: 3  
50-70 kg: 4 6  
 

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70-100 kg: 5  
Again depending on body weight of patients, i-gel numbered as follows will be inserted:  
30-60 kg: 3  
50-90 kg: 4  
>90 kg: 5.  
Successful insertion of LMA-Supreme or i-gel will be confirmed by square-shaped waves on capnogram, 
easy ventilation with respiration balloon and observation of chest movements. After confirming 
successful emplacement of airway device with fiberoptics, later to prevent observation of the device it 
will be covered. Larnygeal view will be assessed with points from 1 to 3 by the anesthesiologist (complete 
vocal cords view, non-obstructing epiglottis view and obstructed view).  
For successful insertion duration (time from mouth-opening to first successful ventilation), number of 
attempts and ease of insertion will be recorded. Ease of insertion will be assessed as easy, difficult or 
unsuccessful (alternative airway management) by the anesthetist securing the airway (6,30).  
In situations with 3 unsuccessful attempts at securing the airway, patients without LMA-Supreme or i-
gel insertion will have airway management ensured with endotracheal intubation. For oropharyngeal 
leak test after shutting the expirium valve, air will be closed and O2 flow reduced to 3 L/min and the 
first pressure value when a leak sound is heard from the mouth will be recorded as oropharyngeal leak 
pressure. To prevent exposure of lungs to barotrauma, when peak inspiratory pressure (peak) of 40 
cmH2O is reached the expiratory valve will be opened and the test ended (30). This test will be performed 
before peritoneal insufflation, 10 minutes later and immediately before desufflation and will be 
completed by a researcher blind to the type of airway device.  
We considered the concept “margin on oropharyngeal leak pressure (OLP)” (MOLP), defined as the 
value for the margin of pressure between the highest PAW-pk during pneumoperitoneum and the 
maximum safety´s seal pressure value (SP). Our purpose is try to assess the “safety gap” on our patient´s 
airway (in terms of pressure) until it reaches the maximum PAW-pk permitted value under safety 
conditions (SP) (37).  
Positive pressure respiration using a ring system will begin with 2-4 L/min fresh gas flow and FiO2 0.5 
volume control with 6-8 ml/kg tidal volume and 10 respirations/min frequency.  
 

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PEEP will not be applied and I:E ratio will be 1:1,5. ETCO2 will be held from 35-45 mmHg, if necessary 
first respiration frequency will be increased, later tidal volume will be increased. For laparoscopic 
intervention, permission will be given for CO2 insufflation for peritoneal interior pressure of 15 mmHg.  
Two minutes after insertion of LMA-Supreme or i-gel, before insufflation, 10 minutes after insufflation 
and trendelenburg position, immediately before peritoneal desufflation and before removing the airway 
device, ventilation parameters will be assessed.  
Respiratory Measurements recorded: Tidal volume (TV), respiration rate (RR), peripheral oxygen 
saturation (SPO2), end-tidal carbon dioxide pressure (PETCO2), peak airway pressure (Ppeak), mean 
airway pressure (Pmean) and expiratory volume per minute (VE).  
Hemodynamic Measurements recorded: (Simultaneous to the above measurements and additionally 
before induction) systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial 
pressure (MAP), and heart rate (HR).  
Evaluation related to stomach probe: Immediately after the airway device is inserted, through the 
LMA-Supreme (14F for size 3 and 16F for sizes 4 and 5) and i-gel drainage tube a 12F orogastric tube 
will be advanced to the stomach and stomach contents aspirated. The ease of insertion of stomach probe 
and amount of aspirated fluid will be recorded. Ease of insertion of orogastric tube will be classified as 
very easy, easy, difficult or very difficult by the administrator (9). Gastric aspiration will be 200 cmH2O 
during 10 seconds by a suction; (connecting it later to a collection bag).  
The number of interventions of verres needle, initial intra-abdominal pressure, time for intra-abdominal 
pressure to reach 15 mmHg, and volume of insufflated CO2 will be recorded. Sufficiency of 
pneumoperitoneum during operation (sufficient/insufficient), and quality of surgical view will be 
assessed with points from 1 to 4 by the surgeon blind to the airway device (24).  
Stomach distension will be assessed on a scale of 0 to 10 (0= empty stomach, 10 distension obstructing 
view of the surgical field) by a surgeon blind to the airway device immediately after insertion of the 
laparoscope into the abdomen and immediately before the end of peritoneal insufflation and the 
difference between the scores at the start and end of surgery will be recorded (15). Operation table 
positioning (Trendelenburg) will be limited to a maximum 30º.  
 

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When the patient is cooperative, the LMA-Supreme or i-gel will be removed and total anesthesia duration 
and peritoneal insufflation duration will be recorded. Complications that may develop during airway 
device removal (cough, vomiting, laryngeal stridor, laryngeal spasm or airway intervention requirements) 
will be recorded.  
After removing the SGAD, the presence of blood will be assessed as:  
1: no blood  
2: trace amounts of blood  
3: clear amounts of blood  
Conscious patients will be taken to the recovery unit and a blind researcher will evaluate throat pain, 
voice loss and difficulty swallowing in the 1st and 24th hours. For evaluation of throat pain, VAS-10 
(visual analog scale) will be used.  
Criteria:  
Inclusion Criteria:  
1.American Society of Anesthesiologists classification group I-II  
2.between 18-65 years  
3.undergoing elective laparoscopic gynecological surgery  
Exclusion Criteria:  
1.Those with any neck or upper respiratory tract pathology  
2.Those at risk of gastric content regurgitation/aspiration (previous upper Gastrointestinal system 
surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcers, full stomach, pregnancy)  
3.Those with low pulmonary compliance or high airway resistance (chronic pulmonary diseases)  
4.Obese patients (BMI >35)  
5.Those with throat pain, dysphagia and dysphonia  
6.Those with possible or previous difficult airway  
7.Those with operations planned for longer than 4 hours  
 

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8.Conversion to laparatomy  
9.Neuromuscular blocking agent used  
Statistical Analysis  
In a study that was conducted by Seet et al., power was calculated as 90% as a result of the power 
analysis that was made for laryngeal mask airway OLP=>21+/-5 cmH2O average values; and the number 
of the case was determined to be 40 for each group (30). 
The data have been evaluated with the SPSS (Statistical Package for Social Sciences) 15.0 
package program. The fitness of the variables to normal distribution was tested with the Kolmogorov 
Smirnov Test. The t-test was used to compare the two groups that fit normal distribution; and the Mann 
Whitney U-Test was used for those that did not fit normal distribution. The variables that were defined 
with numbers were evaluated with the Chi-Square Test and with the Fisher’s Exact Test when needed; 
and the significance level was taken as p<0.05. The mean, standard deviation, median, min. and max. 
values of the continuous variables and their sub-groups were presented; and the frequency numbers and 
percentages of the class variables were presented. 
 
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