European Journal of Cardiovascular Medicine

Laparoscopic cholecystectomy has replaced open surgery as the standard for gallbladder removal due to its minimally invasive benefits, including reduced pain, quicker recovery, and shorter hospital stays.^1,2,3 However, pneumoperitoneum and Trendelenburg positioning create airway and ventilation challenges, necessitating secure airway management.

The cuffed endotracheal tube (ETT) remains the gold standard, offering airway protection and controlled ventilation, but it is associated with sympathetic stimulation, tachycardia, hypertension, and postoperative airway trauma.¹ Supraglottic devices such as the I-gel have emerged as alternatives. Made of a soft thermoplastic elastomer, the I-gel conforms anatomically without an inflatable cuff, simplifying insertion and reducing mucosal injury risk.

Studies suggest that I-gel insertion is easier, quicker, and associated with fewer hemodynamic changes compared to ETT.³ However, evidence in the Indian population undergoing laparoscopic surgery is limited. This study compared I-gel and ETT for insertion characteristics, ventilatory parameters, hemodynamic responses, and complications in elective laparoscopic cholecystectomy.

SThis prospective, randomized trial was conducted at a tertiary care hospital (June 2024–January 2025) after ethics approval (SMVDNSH/IEC/2024/05). Written informed consent was obtained.

Participants: ASA I–II patients, 18–60 years, undergoing elective laparoscopic cholecystectomy were included. Exclusion criteria: predicted difficult airway, obesity, gastroesophageal reflux, hemodynamic instability, pregnancy, significant systemic illness, history of allergic reactions to medications used during anaesthesia, any neurological deficit, chronic intake of psychotropic medications or analgesics.

Randomization and Groups: Patients were randomized using the sequentially numbered opaque sealed envelope (SNOSE method) to I-gel (Group I) or ETT (Group E). Device selection followed manufacturer guidelines.

Anesthesia Protocol: Premedication included midazolam (0.02 mg/kg) and fentanyl (2 µg/kg). Induction: propofol (2 mg/kg); relaxation: atracurium (0.6 mg/kg). Devices were inserted by a single experienced anaesthesiologist. Placement was confirmed by chest auscultation and capnography.

Monitoring: Standard ASA monitors were applied. Parameters recorded included insertion time, attempts, ease of placement, hemodynamic (heart rate, BP), peak airway pressure (PAP), and EtCO₂ pre- and post-pneumoperitoneum.

In Group I, an appropriately sized I-gel was inserted according to manufacturer guidelines, with size 3 used for patients weighing <50 kg, size 4 for those between 50–70 kg, and size 5 for those weighing >70 kg. In Group E, an appropriate-sized cuffed endotracheal tube (size 8.0–8.5 for males and size 7.0–7.5 for females) was inserted using laryngoscopy. All devices were inserted by a single experienced anaesthesiologist to minimize inter-operator variability. Correct placement was confirmed by bilateral chest auscultation, observation of chest rise, and capnographic waveform analysis. Gastric tube insertion was attempted in both groups, and the occurrence of gastric insufflation was assessed by auscultation over the epigastrium during manual ventilation. The number of attempts required for successful device placement was noted, with removal and reinsertion constituting a failed attempt.

Anaesthesia was maintained with isoflurane (1–1.5 MAC) in a 50% oxygen-air mixture, along with intermittent doses of atracurium as required. Controlled ventilation was provided with a tidal volume of 7–10 ml/kg and respiratory rate adjusted to maintain EtCO₂ between 35–45 mmHg and oxygen saturation ≥95%. Peak airway pressure (PAP) and EtCO₂ were recorded before and after pneumoperitoneum. Hemodynamic variables including pulse rate (PR), mean blood pressure (MBP), oxygen saturation (SpO₂), and electrocardiography findings were continuously monitored throughout the perioperative period.

At the conclusion of surgery, neuromuscular blockade was reversed with atropine (0.02 μg/kg) and neostigmine (0.04 mg/kg). Removal of the airway device was performed after confirming adequate spontaneous respiration and restoration of muscle tone. The presence of visible blood on the device was documented to assess airway trauma. In the recovery unit, patients were observed for 45 minutes, and postoperative complications such as sore throat, dysphonia, and dysphagia were assessed by a blinded independent observer.

Outcomes:

Primary: Insertion ease and time, hemodynamic stability.

Secondary: PAP, EtCO₂, oxygen saturation, postoperative complications.

Sample Size & Statistics: Based on Golmohammadi et al., 32 patients per group were required for 95% confidence. Data were analysed using SPSS v22; p<0.05 was significant.

A total of 64 patients were enrolled in the study, with 32 allocated to the I-gel group and 32 to the endotracheal tube (ETT) group. The demographic characteristics of the patients were comparable between the two groups. The distribution of age did not differ significantly (p=0.634), with the majority of patients in both groups falling within the 36–40 years age range. Similarly, sex distribution revealed a female predominance in both groups, accounting for 65.6% in the I-gel group and 71.9% in the ETT group, with no statistically significant difference observed (p=0.590). Body mass index (BMI) was also similar across groups (p=0.802), with 56.3% of patients in the I-gel group and 53.1% in the ETT group having a BMI of less than 25 kg/m². Educational status and place of residence were well matched, with no significant variation between groups (p=0.499 and p=1.000, respectively), thus ensuring comparability of baseline demographic characteristics. (Table 1, Figure 1)

Table 1: Sociodemographic and clinical characteristics of the participants

Figure 1: Bar chart showing the distribution of Body Mass Index (BMI) among participants in the I-gel and ETT groups.

Bar chart comparing the proportion of patients with BMI <25 kg/m² and ≥25 kg/m² in the I-gel and ETT groups. Values in each bar indicate the number of patients.

Airway device performance demonstrated important differences. All insertions in the I-gel group were successful on the first attempt (100%), while in the ETT group, 96.9% of patients had successful first-attempt placement and 3.1% required a second attempt; however, this difference was not statistically significant (p=0.313). The ease of insertion, however, favoured the I-gel significantly (p=0.043), with 93.8% of insertions rated as easy compared to only 71.9% in the ETT group, where moderate or difficult insertions were more frequently encountered. Furthermore, the mean time for insertion was significantly lower in the I-gel group (14.8 ± 9.5 seconds) compared to the ETT group (22.8 ± 11.4 seconds) (p<0.001), indicating that I-gel provided a quicker and smoother insertion process. (Table 2, Figures 2, 3 4)

Table 2: Comparison of insertion characteristics, peak airway pressure, and EtCO₂ between study groups

Figure 2: Box plot comparing the time taken (seconds) for insertion of the I-gel and endotracheal tube

The horizontal line represents the median, the box shows the interquartile range, and whiskers indicate minimum–maximum values. Mean values are marked in the boxes.

Figure 3: Line graph depicting the trend in peak airway pressure (mmHg) before insertion, after insertion, and 20 minutes post-pneumoperitoneum in both study groups

Data labels represent mean values: Before insertion: I-gel = 12.7, ETT = 12.8; After insertion: I-gel = 17.3, ETT = 18.2; 20 min post-pneumoperitoneum: I-gel = 19.3, ETT = 20.1

Figure 4: Line graph depicting the trend in end-tidal CO₂ (EtCO₂, %) before insertion, after insertion, and 20 minutes post-pneumoperitoneum for I-gel and ETT groups

Before insertion: I-gel = 28.7, ETT = 39.1; After insertion: I-gel = 37.7, ETT = 41.7;

20 min post-pneumoperitoneum: I-gel = 37.2, ETT = 39.4

Hemodynamic parameters showed a trend toward greater stability in patients managed with the I-gel. Baseline heart rates were comparable between the groups; however, following induction and throughout the perioperative period, patients in the ETT group demonstrated significantly higher heart rates at several time points. In particular, heart rate was elevated at 3 minutes (p=0.015), 5 minutes (p=0.033), during pneumoperitoneum (p=0.003), after pneumoperitoneum (p=0.023), and after device removal (p=0.033), reflecting increased sympathetic stimulation associated with tracheal intubation and extubation. In contrast, systolic blood pressure, diastolic blood pressure, and mean arterial pressure remained relatively stable and did not show statistically significant differences between the two groups at any time point, suggesting that both airway devices maintained overall hemodynamic stability. (Figure 5 to 8)

Figure 5: Perioperative hemodynamic parameters. (A) Heart rate, (B) Systolic blood pressure, (C) Diastolic blood pressure, (D) Mean arterial pressure in the I-gel and ETT groups across perioperative time points.

Composite panel showing changes in perioperative hemodynamic variables between I-gel and ETT groups: (A) Heart rate, (B) Systolic blood pressure, (C) Diastolic blood pressure, (D) Mean arterial pressure. Data labels indicate mean values at each perioperative time point as follows:

1. Heart Rate (HR): I-gel: Baseline 80; 3 min 82; 5 min 81; During pneumoperitoneum 83; After82; Post-removal 81

ETT: Baseline 80; 3 min 90; 5 min 88; During pneumoperitoneum 95; After 92; Post-removal 89

2. Systolic Blood Pressure (SBP):

I-gel: 120 → 121 → 122 → 123 → 122 → 121

ETT: 120 → 122 → 124 → 125 → 124 → 123

3. Diastolic Blood Pressure (DBP):

I-gel: 75 → 76 → 76 → 77 → 76 → 76

ETT: 75 → 77 → 78 → 79 → 78 → 78

4. Mean Arterial Pressure (MAP):

I-gel: 90 → 91 → 91 → 92 → 91 → 91

ETT: 90 → 92 → 93 → 94 → 93 → 93

Ventilatory parameters further distinguished the two groups. Peak airway pressure (PAP) was significantly lower in the I-gel group both immediately after device insertion (17.3 ± 0.6 mmHg vs. 18.2 ± 0.8 mmHg; p=0.002) and at 20 minutes after pneumoperitoneum (19.3 ± 1.5 mmHg vs. 20.1 ± 1.2 mmHg; p=0.046). Similarly, end-tidal CO₂ (EtCO₂) levels were significantly lower in the I-gel group after insertion (37.7 ± 1.9 vs. 41.7 ± 2.3; p<0.001) and at 20 minutes (37.2 ± 1.9 vs. 39.4 ± 2.2; p=0.001), indicating more favourable ventilation dynamics and reduced airway resistance with I-gel compared to ETT. Oxygen saturation remained above 95% in all patients across both groups, confirming adequate oxygenation throughout. (Table 2)  

The present study was conducted to compare the performance of the I-gel supraglottic airway device with the conventional endotracheal tube (ETT) in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia. The findings demonstrate that both airway devices were effective in securing the airway and maintaining adequate ventilation. However, the I-gel showed significant advantages in terms of ease and rapidity of insertion, lower peak airway pressures, reduced end-tidal CO₂ levels, greater hemodynamic stability, and a lower incidence of postoperative complications. These results contribute to the growing body of evidence supporting the use of I-gel as a reliable alternative to the ETT in selected laparoscopic procedures.

Airway management during laparoscopy poses unique challenges due to the creation of pneumoperitoneum, which increases intra-abdominal pressure, elevates the diaphragm, and decreases lung compliance. These changes may result in impaired ventilation and higher airway pressures. Traditionally, the ETT has been regarded as the gold standard because of its ability to provide a secure glottic seal and protect against aspiration. However, the process of laryngoscopy and intubation is associated with significant sympathetic stimulation, which can precipitate tachycardia, hypertension, and even myocardial ischemia in susceptible patients. In contrast, supraglottic airway devices such as the I-gel can be inserted more quickly and with less sympathetic stimulation, making them particularly advantageous in patients with cardiovascular comorbidities.

In the present study, the I-gel demonstrated a clear advantage over the endotracheal tube (ETT) by requiring significantly less time for insertion and being rated as easier to insert in the majority of patients. This finding is consistent with previous work by Massoud et al. and Michalek et al., who similarly reported that I-gel placement is simpler, quicker, and demands less technical expertise compared with tracheal intubation.[i]^{, [ii]} The 100% first-attempt success rate achieved in the I-gel group in this study further highlights its reliability, making it a dependable choice for airway management. Unlike ETT, which typically requires laryngoscopy and greater skill, I-gel’s design allows for a more intuitive, blind insertion technique, reducing the learning curve for less experienced practitioners.⁷ These attributes are particularly valuable in emergency scenarios where rapid airway control is essential, as well as in environments with limited availability of advanced airway specialists. Moreover, the ease of insertion minimizes patient discomfort and reduces the potential for airway trauma, thereby enhancing overall safety.

Hemodynamic responses were also more favourable with I-gel. Patients in the ETT group exhibited significantly higher heart rates at multiple perioperative time points, particularly after intubation, during pneumoperitoneum, and following device removal. This is consistent with the work of Adhikari et al., who demonstrated that the I-gel is associated with minimal hemodynamic fluctuations compared to the ETT. [iii] The absence of significant changes in systolic, diastolic, and mean arterial pressures in both groups indicates that anaesthesia was adequately maintained; however, the heart rate variations highlight the greater sympathetic stimulation induced by laryngoscopy and tracheal intubation. In clinical practice, this distinction is important, especially in patients with ischemic heart disease or poorly controlled hypertension, where abrupt changes in heart rate can be deleterious. Similar findings have been reported by Zuberi et al. and Ahirwar et al. in their studies. [iv]^, [v]

Ventilatory parameters also favoured the I-gel. Peak airway pressures and EtCO₂ levels were significantly lower in the I-gel group both after insertion and at 20 minutes following pneumoperitoneum. Lower airway pressures suggest reduced resistance and better compliance, which are advantageous in laparoscopic procedures where pulmonary mechanics are already compromised. These findings are in agreement with results from Golmohammadi et al. and Dhanda et al., who reported effective ventilation with I-gel during laparoscopy, with airway pressures comparable or superior to those achieved with ETT.⁷, [vi]  Importantly, oxygen saturation remained well maintained in all patients, demonstrating that both devices were adequate in ensuring oxygenation.

Despite these encouraging findings, it is important to note that the I-gel does not offer the same degree of airway protection against aspiration as the ETT. In this study, only low-risk patients (ASA I–II, non-obese, without gastroesophageal reflux disease or delayed gastric emptying) were included. Therefore, caution must be exercised when extrapolating these results to high-risk populations. In patients with anticipated difficult airways, obesity, pregnancy, or those undergoing prolonged laparoscopic procedures with increased aspiration risk, endotracheal intubation may still be preferable.

One of the major strengths of this study lies in its randomized design, which minimized selection bias and enhanced the reliability of comparisons between the I-gel and endotracheal tube groups. Baseline demographic and clinical characteristics were well-matched, ensuring that outcomes were attributable to the airway device rather than confounding factors. The use of a standardized anaesthetic protocol and having a single experienced anaesthesiologist perform all insertions further reduced variability, strengthening the internal validity of the findings. Additionally, the prospective nature of data collection, comprehensive monitoring of hemodynamic and ventilatory parameters, and inclusion of both primary and secondary outcomes—such as insertion ease, peak airway pressures, end-tidal CO₂, and postoperative complications—provided a robust and multifaceted assessment of device performance. However, certain limitations should be acknowledged. The relatively small sample size may limit the generalizability of the findings, and the study was conducted in a single centre, which may restrict external validity.

I-gel is a safe and effective alternative to ETT for airway management in low-risk laparoscopic cholecystectomy patients. It offers faster, easier insertion, greater hemodynamic stability, lower airway pressures, and fewer complications. While ETT remains essential in high-risk cases, I-gel should be considered for routine laparoscopic procedures.

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