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Table of Contents  
ORIGINAL ARTICLE
Year : 2017  |  Volume : 11  |  Issue : 4  |  Page : 930-933  

Comparison of I-gel versus endotracheal tube in patients undergoing elective cesarean section: A prospective randomized control study


1 Department of Anesthesia, Karpaga Vinayaga Institute of Medical Sciences, Madurantagam, Tamil Nadu, India
2 Department of Anesthesia, GSVM Medical College, Kanpur, Uttar Pradesh, India

Date of Web Publication28-Nov-2017

Correspondence Address:
Manohar Panneer
29/21, Flat A1, Ranga Shelters, Devadoss Street, Vedachalam Nagar, Chengalpattu, Kanchipuram - 603 001, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/aer.AER_32_17

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   Abstract 


Background and Aim: Physiological changes during pregnancy and the sympatho adrenalstimulation during larynoscopy and intubation leads to evaluation of safe devices to secure airway during cesarean section under general anesthesia. I-gel, recently emerging effective supra glottic device found safe during general anesthesia in cesarean section. Aim of the study is to compare the hemodynamic disturbances and airway related complications of I-gel and Endotracheal tube in patients undergoing cesarean section under general anesthesia. Material and Methods: Eighty ASA II pregnant patients posted for elective LSCS were randomly divided into two groups of 40 each (n = 40). According to the group they were inserted either I-gel (Group I) or ETT (Group E). Insertion time, ease of intubation, hemodynamics during insertion and Extubation, airway related complications like sore throat, blood on the device, dysphagia, regurgitation, nausea, vomiting, aspiration and laryngospasm were noted and compared. Statistical analysis was done by using unpaired t test, chi square test and fisher's test. P value of <0.05 was considered as significant. Results: The demographic parameters, ease of insertion, insertion times and adequacy of ventilation were comparable between the groups (P > 0.05). 8 out of 40 patients in Group E had difficult intubation (P < 0.01). More than 20% of rise in MAP and HR were found during intubation and Extubation in Group E (40 out of 40 patients) which was statistically significant when compared to Group I (P < 0.001).Post operative sore throat significantly high in Group E (30 out of 40) (P < 0.001) when compared to Group I (4 out of 40). Conclusion: Easier insertion with less hemodynamic disturbances and very low incidence of sore throat I-gel found to be safer device to secure the airway in patients undergoing LSCS under general anesthesia.

Keywords: Cesarean section, endotracheal tube, general anesthesia, I-Gel


How to cite this article:
Panneer M, Babu S, Murugaiyan P. Comparison of I-gel versus endotracheal tube in patients undergoing elective cesarean section: A prospective randomized control study. Anesth Essays Res 2017;11:930-3

How to cite this URL:
Panneer M, Babu S, Murugaiyan P. Comparison of I-gel versus endotracheal tube in patients undergoing elective cesarean section: A prospective randomized control study. Anesth Essays Res [serial online] 2017 [cited 2019 Jul 22];11:930-3. Available from: http://www.aeronline.org/text.asp?2017/11/4/930/207805




   Introduction Top


Physiological changes that occur in the airway and other organ systems during pregnancy have made anesthesia challenging for an anesthetist.[1] The subarachnoid block is the preferred choice of anesthesia for cesarean section (CS). In some situations, where spinal anesthesia (SA) is contraindicated, general anesthesia (GA) will be preferred. Endotracheal intubation by rapid sequence induction is usually preferred in pregnant patients due to airway edema and risk of aspiration.[2]

In obstetric patients, the enlarged breasts, weight gain, and airway edema make intubation difficult. There is also high chances of intubation failure.[3],[4] During laryngoscopy and intubation, there is profound stimulation of adrenergic system resulting in increase in heart rate (HR), blood pressure, myocardial oxygen demand, and arrhythmias.[5],[6] As a result, there may be increased chances for myocardial ischemia and cerebral hemorrhage in the perioperative period. Hence, there is a need of finding some alternative to secure the airway without any adverse effects on the patient.

The advent of supraglottic airway devices (SGADs) to secure the airway has reduced these ill effects by lying outside the vocal cords and providing adequate ventilation.[7] I-gel is a newer SGAD with noninflatable soft cuff which fits very well into laryngeal inlet and creates tight seal. It does not need laryngoscopy and can be used for both spontaneous and controlled ventilation. A nasogastric tube can be placed through the gastric port of I-gel thereby avoiding insufflation of stomach and regurgitation of gastric contents. Furthermore, insertion and maintenance of anesthesia were easier with I-gel when compared with other SGAD.[8] The soft cuff of I-gel fits well with patient's airway anatomy and produces very little trauma to the airway.[9]

To the best of our knowledge, there are not many studies on I-gel use during CS. Hence, we undertook this study to compare the insertion characteristics, hemodynamic disturbances, and airway-related complications between I-gel and endotracheal tube (ETT) in patients undergoing elective CS under GA.


   Materials and Methods Top


After getting Institutional Ethical Committee approval and written informed consent, 80 American Society of Anesthesiologists (ASA) Class II parturient patients, aged between 20 and 30 years who were undergoing elective CS under GA, were enrolled for the study. Patients' refusal, difficult airway, multiple pregnancy, cardiac and respiratory diseases, pregnancy-induced hypertension, gestational diabetes, and other medical or surgical complications were excluded from the study. Patients were randomly assigned to one of the two groups in a double-blinded fashion using computer-generated random number code: Group I (n = 40)-GA with I-gel and Group E (n = 40)-GA with ETT.

A night before and on the morning of surgery, patients were given tablet ranitidine 150 mg and tablet ondansetron 4 mg. Overnight fasting was ensured. In the operation room, an intravenous access was secured with an 18-gauge cannula, and all standard noninvasive ASA monitors were attached (electrocardiograph, blood pressure, pulse oximeter, temperature probe, and end-tidal carbon dioxide [ETCO2]). GA was induced with injection propofol 2 mg/kg, injection fentanyl1 mcg/kg, and succinylcholine 1.5 mg/kg. Rapid sequence induction was followed in all the patients. The airway was secured with either ETT or I-gel as per the randomized group. Insertion of the airway devices was performed by an experienced anesthetist who was blinded to the study. Anesthesia was maintained with 1%–1.5% isoflurane and injection vecuronium (0.01 mg/kg). The tidal volume and respiratory rate were adjusted to achieve ETCO2 between 32 and 40 mmHg. All the patients in Group I were inserted with 12 Fr nasogastric tube. Application of fundal pressure was restricted to avoid regurgitation which can lead to aspiration. Injection fentanyl 1 mcg/kg and injection oxytocin 20 units in 500 ml Ringer lactate solution were given over 15–20 min after the delivery of baby. After surgery, reversal of neuromuscular blockade was done with injection neostigmine (0.05 mg/kg) and injection glycopyrrolate (0.01 mg/kg). Once patient was fully awake, the airway devices were removed without suction. Airway devices were then checked for any blood stain, vomitus, or bile. The gastric aspirate was checked by testing the cuff for pH with litmus paper. A pH of <2.5 was considered to be gastric aspiration, and X-ray of the chest was planned postoperatively.

The following observations were made by another anesthetist who was also blinded for the study groups: (1) Ease of insertion: (a) easy – Inserted at first attempt within 40 s, (b) difficult – Inserted at more than one attempt, and (c) failed – Could not be inserted after two attempts; (2) Insertion time – time duration between insertion of device and appearance of square wave in capnogram; (3) Mean arterial pressure (MAP) and HR every 2 min for 10 min after insertion and removal of airway devices; (4) Any episode of hypoxia (SPO2 <90%); and (5) Postoperative complications: (a) blood stain on device, (b) gastric aspiration, (c) sore throat, (d) regurgitation, (e) dysphagia, (f) laryngospasm, and (g) nausea and vomiting.

Statistical analysis

Based on the previous study,[10] the mean time taken for insertion of I gel is 11.12 s; we anticipated insertion time to be around 11 ± 2 s. Hence, sample size of >32 was required to achieve 85% of power and significant level of 5%. Hence, sample size of 40 was taken per group to avoid any loss of cases during the study. Continuous variables were expressed as mean ± standard deviation, and qualitative data were expressed as numbers (n) and percentages (%). Unpaired Student t-test was used to evaluate age, weight, and insertion time. Chi-square test or Fisher's test was used to compare the other qualitative parameters between the groups. Statistical Package for the Social Sciences (SPSS, Version 16.0; SPSS Inc., IBM, Chicago, IL, USA) was used to analyze the variables. P < 0.05 is considered statistically significant.


   Results Top


The demographic profile and duration of surgery were comparable in both groups [Table 1]. The baseline MAP and HR were comparable between the two groups. The I-gel insertion was easy with all the 40 patients in Group I whereas in Group E, eight patients had difficult intubation. None of the patients in either group had failed insertion [Table 2]. The time taken for insertion of I-gel (10.3 ± 2.4 s) was significantly less in comparison to ETT (12.5 ± 3.2 s) [Table 2]. There were no episodes of hypoxia in both groups.
Table 1: Demographic profile and duration of surgery in both groups

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Table 2: Device insertion characteristics in both groups

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After the insertion of airway devices, the MAP and HR were significantly lower in Group I when compared with Group E. This difference has become comparable and nonsignificant, only after 8 min of insertion [Figure 1]a and [Figure 1]b. The same was observed after the removal of airway devices [Figure 2]a and [Figure 2]b. During insertion or intubation, one patient in Group I showed increase in HR and MAP by more than 20% of the baseline values, whereas in Group E, all 40 patients showed a rise of more than 20% above the baseline readings.
Figure 1: Comparison of (a) heart rate and (b) mean arterial pressure between Group I and Group E after the insertion of airway devices

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Figure 2: Comparison of (a) heart rate and (b) mean arterial pressure between Group I and Group E after the extubation of airway devices

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The incidence of sore throat in the postoperative period was significantly higher in Group E when compared with Group I. Presence of blood stain on airway devices were not significant in both the groups. None of the patients in either group had other complications [Table 3].
Table 3: Comparison of postoperative complications in both groups

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   Discussion Top


During CS of parturients, anesthesiologist has the prime responsibility for the safety of both mother and fetus. Usually, regional anesthesia is preferred over GA for CS. However, in some circumstances, GA becomes the choice.[1] Sympathetic stimulation, failed intubation, and risk of aspiration are the unanticipated adverse effects of intubation during GA.[2],[3],[4],[5],[6] The need for ideal and safe alternative to the ETT made the emergence of SGAD in securing the airway in controlled ventilation. Among various SGADs, I-gel is more ideal due to soft consistency, easier to insert, noninflatable cuff, and leak-free airway.[7],[8],[9] Since the role of I-gel in pregnant patients is unexplored, we commenced this study to compare the hemodynamic response and postoperative complications of I-gel GA with standard ETT GA.

In our study, the insertion of I-gel had no difficult or failure rates whereas ETT tube had incidence of eight difficult intubation. This may be attributed to the ease of insertion and requirement of less manipulation of oro-pharyngo-tracheal axis and no cuff inflation in I-gel. Therefore, time taken for securing an airway with I-gel (10.3 ± 2.4 s) is rapid in most of the patients in our study. These results were similar to the findings of the study by Chauhan et al.[10] where the I-gel was compared with ProSeal laryngeal mask airway (PLMA) for GA in general surgery and orthopedic cases. Usually, obstetric patients have more risk of difficult intubation when compared with general surgery cases.[4] We also had 20% difficult intubation rates in Group E. These findings were also observed in the study by Chauhan et al.[10] Study by Han et al.[11] has showed that the SGAD was effective and safe for elective CS under GA. Our study also showed the use of I-gel in parturients for GA was safe with minimal side effects. Saini et al.[12] compared PLMA with ETT in elective CS patients. They found that the insertion of PLMA is easier than ETT and the postoperative sore throat incidence was less in PLMA group. We also obtained similar results by using I-gel in obstetric patients undergoing elective CS.

In elective CS under GA, ETT is no way inferior to other SGAD. However, when considering the hazards of sympathetic stimulation during laryngoscopy and endotracheal intubation, we are in the need of identifying a suitable alternative to ETT. The same was observed in our study, where all the patients in Group E had significant rise in MAP and HR when compared with Group I. Our study results on hemodynamic response are similar to previous study by Ismail et al.,[13] where the use of I-gel for GA has provided minimal changes in HR, MAP, and intraocular pressure in comparison with other airway devices in patients undergoing ophthalmic procedures.

Chauhan et al.,[10] Jadhav et al.[14] compared the use of I-gel and PLMA in patients undergoing general surgery cases. They found that incidence of sore throat, blood stain on the device, and dysphagia were significantly less with I-gel when compared with PLMA. However, in our study, the incidence of sore throat alone was significantly less in I-gel group whereas the other complications were not significant. This shows the ETT also has less side effect profile in comparison with PLMA.

Literatures have shown that incidence of postextubation sore throat, mucociliary dysfunction, laryngeal edema, and hoarseness of voice were less with the use of SGAD when compared with ET tube.[15],[16],[17],[18] Furthermore, SGAD with an inflatable cuff has the potential to cause tissue distortion, venous compression, and nerve injury. Trauma during insertion, multiple insertion attempts, cuff volume, and pressure exerted by the cuff against the pharyngeal mucosa have all been implicated for postoperative complications.[19],[20],[21],[22],[23] Ease of insertion, proper anatomic fit, no manipulations to adjust the device, absence of inflating cuff, and presence of gastric port for stomach deflation were the reasons for less incidence of postoperative complications in I-gel group in our study.

Although our study favors the use of I-gel in CS, it has certain limitations. Larger number of patients would have added better strength to our results. Neonatal outcome was not measured in our study. Although ETT is more effective in providing adequate airway seal, we have not tested the airway leak pressure in I-gel.

The overall outcome of our study adds evidence and strength to the previous studies by Berger et al.[24] and Badheka et al.[25] which suggested that I-gel is likely to be a superior choice in obstetric anesthesia because of easier insertion, fewer insertion attempts, less traumatic and minimal hemodynamic fluctuations.

In future, research studies comparing I-gel and newer intubating LMA devices should be carried out so that an effective alternative to ETT can be safely provided in obstetric patients.


   Conclusion Top


It can be concluded that considering ease of insertion, lesser hemodynamic disturbances, and very low incidence of airway complications, I-gel is found to be a better alternative to ETT in patients undergoing elective CS under GA.

Financial support and sponsorship

Financial support from Department Research Funds and drugs from pharmaceutical companies were obtained.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

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Brinbach J, Browne M. Anaesthesia for obstetrics. In: Miller RD, editor. Anaesthesia. 7th ed. Philadelphia: Churchill Livingstone; 2010. p. 2203-25.  Back to cited text no. 1
    
2.
Fenton PM, Reynolds F. Life-saving or ineffective? An observational study of the use of cricoid pressure and maternal outcome in an African setting. Int J Obstet Anesth 2009;18:106-10.  Back to cited text no. 2
    
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Ruklidge M, Hinton C. Difficult and failed intubation in obstetrics. Contin Educ Anaesth Crit Care Pain 2012;12:86-91.  Back to cited text no. 3
    
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Djabatey EA, Barclay PM. Difficult and failed intubation in 3430 obstetric general anaesthetics. Anaesthesia 2009;64:1168-71.  Back to cited text no. 4
    
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Hassan HG, el-Sharkawy TY, Renck H, Mansour G, Fouda A. Hemodynamic and catecholamine responses to laryngoscopy with vs. without endotracheal intubation. Acta Anaesthesiol Scand 1991;35:442-7.  Back to cited text no. 5
    
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Brain AI, Verghese C, Strube PJ. The LMA 'ProSeal' – A laryngeal mask with an oesophageal vent. Br J Anaesth 2000;84:650-4.  Back to cited text no. 7
    
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Levitan RM, Kinkle WC. Initial anatomic investigations of the I-gel airway: A novel supraglottic airway without inflatable cuff. Anaesthesia 2005;60:1022-6.  Back to cited text no. 8
    
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11.
Han TH, Brimacombe J, Lee EJ, Yang HS. The laryngeal mask airway is effective (and probably safe) in selected healthy parturients for elective cesarean section: A prospective study of 1067 cases. Can J Anaesth 2001;48:1117-21.  Back to cited text no. 11
    
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Saini S, Ahuja S, Guleria K. To evaluate the use of proseal laryngeal mask airway in patients undergoing elective lower segment cesarean section under general anesthesia: A prospective randomized controlled study. J Obstet Anaesth Crit Care 2016;6:11-5.  Back to cited text no. 12
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13.
Ismail SA, Bisher NA, Kandil HW, Mowafi HA, Atawia HA. Intraocular pressure and haemodynamic responses to insertion of the i-gel, laryngeal mask airway or endotracheal tube. Eur J Anaesthesiol 2011;28:443-8.  Back to cited text no. 13
    
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Webster AC, Morley-Forster PK, Dain S, Ganapathy S, Ruby R, Au A, et al. Anaesthesia for adenotonsillectomy: A comparison between tracheal intubation and the armoured laryngeal mask airway. Can J Anaesth 1993;40:1171-7.  Back to cited text no. 16
    
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Keller C, Brimacombe J. Bronchial mucus transport velocity in paralyzed anesthetized patients: A comparison of the laryngeal mask airway and cuffed tracheal tube. Anesth Analg 1998;86:1280-2.  Back to cited text no. 18
    
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Gatward JJ, Cook TM, Seller C, Handel J, Simpson T, Vanek V, et al. Evaluation of the size 4 i-gel airway in one hundred non-paralysed patients. Anaesthesia 2008;63:1124-30.  Back to cited text no. 21
    
22.
Brimacombe J, Holyoake L, Keller C, Brimacombe N, Scully M, Barry J, et al. Pharyngolaryngeal, neck, and jaw discomfort after anesthesia with the face mask and laryngeal mask airway at high and low cuff volumes in males and females. Anesthesiology 2000;93:26-31.  Back to cited text no. 22
    
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24.
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25.
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