European Journal of Cardiovascular Medicine

Laparoscopic cholecystectomy, a minimally invasive surgical procedure that has revolutionized the treatment of gallbladder diseases, has become the standard of care since its introduction in the early 1990s. As the surgical technique has evolved, so too have the anaesthetic considerations, particularly the choice of airway management devices.[1] Traditionally, an endotracheal (ET) tube is used in laparoscopic cholecystectomy to secure airway, enabling effective control of ventilation which provides a sealed airway, protects against the risk of aspiration which is a significant concern, especially when abdominal insufflation increases pressure on the stomach and lower oesophageal sphincter due to pneumoperitoneum. This secure airway makes the ET tube particularly advantageous for patients with a high risk of aspiration, obesity, or other comorbidities requiring precise ventilatory control.[2] However, recent advancements in supraglottic airway devices (SAD) have led to increasing use of I-gel. The I-gel device, with its unique gel-like cuff, allows for a simpler insertion process and offers a less invasive option than the ET tube. I-gel devices do not require the same depth of anesthesia as ET intubation, which can reduce the anaesthetic requirements and potentially speed up recovery times and does not pass through the vocal cords or trachea, thereby reducing the risks of laryngeal or tracheal injuries. The I-gel may be suitable for selected laparoscopic procedures with patients who have a low risk of aspiration, require short surgical durations, beneficial for patients who are otherwise healthy, for outpatient procedures where minimizing airway trauma and expediting recovery are priorities.[3] The mask of Igel is designed anatomically to the peri-laryngeal structures without the use of an inflatable cuff. This SAD without cuff has advantages including easier insertion and use minimal risk of tissue compression, stability after insertion and manufacturing advantages in terms of simplicity and decreased cost. [4,5,6]

Objectives

• To compare the ease of insertion between I-gel and Endotracheal Tube in patients undergoing elective laparoscopic cholecystectomy
• To determine and compare the degree of hemodynamic changes insertion of I-gel and Endotracheal tube and efficacy of ventilation in patients undergoing laparoscopic

The study was a hospital based observational study undertaken in General surgery OT complex, under Department of Anesthesia, Assam Medical College and hospital for a period of 2 months (1st January 2025 to 28^th February 2025) after obtaining Institutional Ethical Committee Clearance (H).

The sample size was calculated as:

After 1 minute of induction mean arterial pressure (MAP) for the ET tube was 122.93±8.69 and for I-Gel [7] was 112.46±1.18 mmHg.

s1 =8.69, s2 =8.80, μ1 =122.93, μ2 =112.46, at 5% level of significant. Zα/2 =1.96, Z1-β =1.18, at 95% power, sample size for each group for I-gel and ET Tube came to be 15. Then sample size was increased to 30 in each group. So, total of 60 patients of both sexes were included in the study.

Inclusion criteria:

• Patients aged between20-60 years,
• Patients of either sex,
• Patients with ASA physical status of I&II,
• Patients scheduled for elective laparoscopic cholecystectomy,
• Duration of surgery 30 mins to 90 mins,
• Patients having Body mass index (BMI) less than 0 kg/m^2.

Exclusion criteria:

Patients giving refusal to consent for the study,

• Patients with expected difficult airway, limited mouth opening,
• Patients with some pathology of neck or upper respiratory tract infection, preoperative history of sore throat and cervical spine diseases,
• Patients at risk of gastroesophageal regurgitation/aspiration,
• Patients with chronic diseases like hypertension, diabetes, bronchitis, asthma,
• Patients undergoing surgery with expected operation time more than 2 hours.

Patients were randomly allocated to one of the two groups, Group A and Group B of 30 patients. Consecutive participants were enrolled in the groups fulfilling the inclusion criteria till adequate sample size was achieved in each group. In Group A, I-gel of appropriate size was inserted, and in Group B, endotracheal intubation was done.

On the day of operation, standard protocols of preoperative evaluation and fasting guidelines was followed and written consent from patients was obtained. After arrival in operating room patient was monitored for baseline parameters like Oxygen Saturation (SpO2), Heart Rate and Noninvasive Blood Pressure (NIBP), Respiratory rate. Following insertion of an IV catheter and premedication with injection glycopyrrolate (4µg/kg), fentanyl (1–2 µg/kg) and ondansetron (0.1 mg/kg) then induced with Propofol (2-5mg/kg) and muscle relaxant Rocuronium 1mg/kg was administered to the participants to achieve adequate depth of anesthesia and then appropriate size SAD and Endotracheal tube was inserted according to the manufacturer’s recommendation. Correct placement of the airway device was confirmed by five-point chest auscultation, adequate chest rise, presence of a continuous end-tidal CO₂ waveform, SPO2 >95%. In I-gel group lubricated gastric tube was also passed through the gastric channel to decompress the stomach. Anesthesia was maintained with oxygen and nitrous oxide mixture (50:50), Sevoflurane at 1–2% concentration to maintain a minimum alveolar concentration (MAC) of 1. Controlled mechanical ventilation was done with tidal volume 6–8 mL/kg, respiratory rate was kept to maintain Etco2 between 35–45 mmHg.

Pneumoperitoneum was created with carbon dioxide insufflation with intra-abdominal pressures maintained at 12–14 mmHg and normothermia was maintained by infusing warm intravenous fluids and controlling the operating room temperature.

Hemodynamic Parameters like pulse rate, blood pressure (SBP, DBP, MBP), SpO2 was recorded and monitored intraoperatively along with End tidal carbon dioxide (EtCO2) was recorded at the time of induction, at the interval of 1 min, 3 min, after creation of peritoneum, and at extubation. Ease of insertion was assessed in terms of time of insertion and number of attempts of respective devices. After completion of surgery, both groups were reversed by injection Suggamadex 4mg/kg, airway devices were removed once patient started breathing spontaneously and airway reflexes returned.

The ease of insertion of the I-Gel and Endotracheal tube was compared as Very easy, Easy, Difficult. Very easy- if the device was inserted without any airway manipulation technique, Easy- if one manipulation was required, and Difficult- if more than one airway manipulation was needed. Ease of insertion was subjectively graded by a single anaesthesiologist in all cases. Chin lift, jaw thrust, head extension and neck flexion manoeuvres were used singly or in combination. The I-Gel of appropriate size according to weight was lubricated and kept ready. The time of insertion was measured with starting point being the anaesthesiologist picking up the device and end point being obtaining an effective airway, confirmed by observing sufficient tidal volume inspired by the patient, SpO2 >95%, capnograph values between 35-45mmHg.

Statistical analysis

All data were presented as Mean ± standard deviation (SD) and compared using unpaired Student’s t-test. Categorical variables were expressed as frequency and percentage and analysed using Chi-square test or Fisher's exact test as appropriate. Changes in hemodynamic parameters over time were assessed using repeated measures analysis of variance (ANOVA). The data were analysed using SPSS version 23 (IBM Corp.,). A p-value of less than 0.05 was considered statistically significant.

A total of 60 patients were enrolled, 30 in each group.

Demographic details of both groups were comparable as shown in Table 1

In our study the mean insertion time for Group A was 11.73±1.62 seconds while for Group B it was 16.50±1.07 seconds with p value less than 0.0001, which is highly statistically significant. In Group A 96.6% cases I-Gel was inserted very easily without resistance and manipulation and 3.33% cases had easy insertion with use of one manipulation technique as shown in Table 2. In Group B 80% cases had ‘very easy’ insertion and 20% had ‘easy’ insertion of ET tube. There was no difficult insertion in both groups. The p value was 0.0444, which is significant, ease of insertion of device was better in I-gel than endotracheal tube. In Group A, 96.67% of participants had I-gel inserted in first attempt and 3.33% had it inserted in 2^nd attempt. In our study the device was inserted successfully in all patients. In Group B, endotracheal tube was inserted in first attempt in 86.67% of cases and in second attempt in

13.33 % of cases. Number of attempts in both the groups were comparable.

Table 2: Comparing the insertion parameters between both the groups

In our study as shown in Table 3,Heart in Baseline, 3 minutes after insertion of device, after pneumoperitoneum and after extubation, the heart rates were comparable except in 1 minute after insertion of device the change in heart rate is significant were p-value was 0.011

showing that the rise of mean heart rate was more in Endotracheal Tube as compared to I- Gel.

Table 3: Comparison of Heart Rate between two groups

Figure 1: Heart rates in both the groups

As shown in Table 4, Mean arterial BP at 1 minutes and 3 minutes after insertion of device were significant, p value<0.05, showing MAP was more in endotracheal tube as compared to I-Gel, rest all values were comparable.

Table 4: Comparison of MAP between two groups

Figure 2: Mean arterial pressure in both the groups

In our study in both the groups the end tidal carbon dioxide in both groups were comparable in all times, as shown in table 5

Table 5: Comparison of EtCO2 in both the groups.

Figure 3: Comparison of Etco2 in both the groups.

Supraglottic airway devices cause less stimulation of the sympathetic nervous system leading to lower hemodynamic instability and the patient tolerates better in light plane of anesthesia, with smooth recovery, without need for laryngoscopy and muscle relaxant. It provides adequate ventilation, oxygenation, delivery of anesthetic agents and has a lower risk of respiratory adverse events, thus replacing the need for conventional tracheal intubation.

In our study the demographic data in both groups were comparable. There was no significant difference in terms of age, gender, BMI. In our study, mean age of study participants was 37±6.37 years in Group A and 39.23±4.96 years in Group B. Mean Body mass index was 23.15±1.22 and 23.16.5±1.01 kg/m2 respectively for Group A and Group B. Mean duration of surgery was 65.33±4.34 minutes for Group A and 59.37±15.84 min for Group B. In Group A 86.67% were female and 13.33% were males, while in Group B 76.67% were females and 23.3% were males. Our study finding was similar to previous studies [8].

In our study, the insertion of I-gel was quicker than endotracheal tube, the mean time of insertion of I-gel (11.73±1.62) was less than the ET tube (16.50±1.07) which highly statically significant. In another study conducted by Badheka et al [9] compared I gel with ETT and found that the mean insertion time was significantly less in I-gel insertion (11.28 ± 2.91seconds) when compared with ETT (14.33 ± 1.56 sec) due to use of laryngoscopy in ET tube which increases its time of insertion. The cuffless, anatomically shaped structure of I- gel contributes to a quicker and simpler insertion process.

In terms of Ease of insertion, I-Gel was easier to insert than ETT and required fewer manipulation technique I I-gel required fewer airway manipulations, as shown by the higher percentage of 'very easy' insertions in I-gel group. In Group A 96.6% cases I-Gel was inserted very easily without resistance and manipulation and 3.33% cases had easy insertion. In Group B 80% cases had ‘very easy’ insertion and 20% had ‘easy’ insertion of ET tube. There were no cases of difficult insertion in either groups. Similar outcomes were reported by Quraishi et al, who noted a smoother insertion experience with I-gel compared to ETT.[10] In our study we used I Gel size 3 for female weighing 30-60 kg and I gel size 4 for Males weighing 50-90 kg as recommended.

In our study number of attempts for device insertion in Group A 96.67% of cases, I-Gel was inserted in first attempt and 3.33% cases required second attempt. In Group B, endotracheal tube was inserted in first attempt in 86.67% of cases and in second attempt in 13.33 % of cases but this association was found to be statistically insignificant. Our study finding is similar to study conducted by Ahiwar et al [7] where they found that number of attempts, I- gel was successfully inserted in first attempt in 90% of the patients while 73.3% patients of endotracheal tube group were intubated in 1st attempt and rest of all patients were intubated in the 2nd attempt.

In our study hemodynamic parameters Heart rate and MAP were comparable in all times except at 1-minute post-insertion which were significantly lower in the I-gel group (p = 0.011 and 0.02, respectively), supporting the reduced sympathetic stimulation associated with supraglottic device placement [11]. Jindal et al. found similar outcomes, reporting that I-gel insertion was associated with lower heart rate and blood pressure spikes compared to endotracheal intubation, supporting the device's advantage in terms of cardiovascular stability.

EtCO2 levels remained comparable between groups, indicating that I-gel provides adequate ventilation even during laparoscopic procedures, as seen in studies by Teoh et al demonstrating the I-gel’s effectiveness in controlled ventilation scenarios [12].

Limitation of the study

Study was limited to participants with ASA grade I and II patients undergoing elective short- duration laparoscopic cholecystectomy, hence, the results may not be applicable to high-risk patients with comorbidities, longer surgeries, or emergency cases .In our study patients having normal airway was included, therefore study results cannot be extrapolated in patients with difficult airway. This was also a single centre, non-randomised and non-blinded study.

Future multicentre randomized controlled trials with a larger cohort are needed to validate the findings.

Based on our study we conclude that I-gel is a suitable alternative to ETT in patients undergoing short-duration laparoscopic surgeries, in otherwise healthy patients in terms of quicker, easier insertion and less hemodynamic changes with comparable ventilatory efficacy making it a valuable airway management option.

Acknowledgement: Our utmost thanks to Department of surgery and Dr. Sagolsem marycharan Devi from Department of community medicine.

Conflict of interest: Nil

1. Gehlot RK, Saxena SS, Raiger LK. A prospective randomised comparative study of ProSeal LMA, I-gel and endotracheal tube in laparoscopic cholecystectomy. Indian J Clin Anaesth. 2018;5(1).
2. Sharma B, Sood J, Sahai C. Supraglottic airway devices in laparoscopic surgeries: A systematic review. Indian J Anaesth. 2017;61(6):464–72.
3. Halwagi A, Massicotte N, Lallo A, Trépanier CA. The I-gel supraglottic airway for positive pressure ventilation during laparoscopic cholecystectomy. Can J Anaesth. 2012;59(7):642–8.
4. Saran S, Mishra SK, Badhe AS, et al. Comparison of I-gel supraglottic airway and LMA-ProSeal™ in pediatric patients under controlled ventilation. J Anaesthesiol Clin Pharmacol. 2014;30:195–8.
5. Beringer R, Kelly F, Cook T, et al. A cohort evaluation of the paediatric I-gel™ airway during anaesthesia in 120 children. Anaesthesia. 2011;66:1121–6.
6. Nirupa R, Gombar S, Ahuja V, et al. A randomised trial to compare I-gel and ProSeal™ laryngeal mask airway for airway management in paediatric patients. Indian J Anaesth. 2016;60:726–31.
7. Ashraf et al. A comparative study of supraglottic airway devices in pediatric patients. Int J Res Med Sci. 2022 Nov;10(11):2549–55.