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A Comparison of Postoperative Throat and Neck Complaints After the Use of the i-gel® and the La Premiere® Disposable Laryngeal Mask: A Double-Blinded, Randomized, Controlled Trial

Keijzer, Christiaan, MD, PhD*; Buitelaar, Dirk R., MD*; Efthymiou, Katina M., MD*; Šrámek, Michael, MD, PhD*; ten Cate, Julia, MD*; Ronday, May, MD*; Stoppa, Tino, MD*; Huitink, Johannes M., MD, PhD; Schutte, Peter F., MD*

Section Editor(s): Glass, Peter S. A.

doi: 10.1213/ANE.0b013e3181b6496a
Ambulatory Anesthesiology: Brief Report
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SDC
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BACKGROUND: Many supralaryngeal airway devices are available. Because of the absence of an inflatable cuff, we hypothesized that use of the i-gel® should produce fewer postoperative throat and neck complaints compared with a standard disposable laryngeal mask (LM).

METHODS: Two hundred eighteen patients were randomized to have either an i-gel or La Premiere® LM airway placed for airway management. Patients were interviewed postoperatively for throat and neck complaints at 1, 24, and 48 h. Interviewers and patients were blinded to the device used.

RESULTS: One hundred nine patients had an i-gel and 103 had a La Premiere supraglottic device inserted. The incidence of sore throat was significantly lower with the i-gel than with LM at 1 (6 vs 32), 24 (7 vs 48), and 48 h (5 vs 25). Similar results were seen for dysphagia. The incidence of neck pain was also lower for the i-gel at 24 (1 vs 7) and 48 h (1 vs 7).

CONCLUSION: In this randomized study, the i-gel supraglottic device resulted in a lower incidence of throat and neck complaints than the La Premiere LM airway.

Published ahead of print July 29, 2009

From the *Department of Anesthesiology and Intensive Care, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital; and †Department of Anesthesiology, VU University Medical Center, Amsterdam, The Netherlands.

Accepted for publication June 16, 2009.

Published ahead of print July 29, 2009

Supported by the Department of Anesthesiology and Intensive Care and the Central Trial Office, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands and Intersurgical Netherlands B.V., Uden, The Netherlands, who provided the study samples.

Address correspondence and reprint requests to Christiaan Keijzer, MD, PhD, Department of Anesthesiology and Intensive Care, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands. Address e-mail to mail@keijzer.com.

Sore throat is a common postoperative complaint from patients in whom a laryngeal mask (LM) is used for airway management. The incidence of sore throat varies between 5.8% and 34% after LM insertion.1 With the introduction of the i-gel® supraglottic airway, a recently developed supraglottic device with a small, noninflatable, anatomically shaped cuff, we hypothesized that the incidence of postoperative throat and neck complaints might be significantly reduced by using this device compared with the standard disposable LM used in our hospital, the La Premiere®.

We therefore conducted a randomized, controlled, double-blinded study in which we compared postoperative throat complaints from patients after general anesthesia with either the i-gel or the La Premiere. As a secondary objective, some functionality variables of the devices were scored single-blinded during anesthesia.

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METHODS

This study was approved by the IRB and written informed consent was obtained from all participating patients. We prospectively randomized 244 patients who were scheduled for elective nonthoracic, nonabdominal surgery under general anesthesia, using a supraglottic device. Because breast cancer surgery patients are the largest group in our hospital to receive surgery under general anesthesia using a supraglottic device, this study included a large percentage of women. Patients were randomly assigned, using permuted blocks of six, generated by computer, to the La Premiere standard disposable LM (Armstrong Medical, Coleraine, Ireland) or the i-gel supraglottic airway (Intersurgical, Uden, The Netherlands). To receive a treatment allocation, the physician had to contact a central trial office by phone. Patients were unaware of the device used. Airway management was performed by all eight anesthesiologists working in The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital. Anesthesia was administered by a standardized protocol using sufentanil, propofol, and desflurane. After loss of eyelash reflex and onset of apnea, either the LM or i-gel was introduced. A Size 4 of each device was used for patients weighing up to 90 kg and Size 5 was used for patients more than 90 kg. Time of insertion was measured in seconds from the start of maneuvering the head to the correct insertion of the device for a maximum of three attempts for the same patient; these measurements were then added together for each patient. The LM was inflated with a maximum of 20 mL of air, and the LM or i-gel was then connected to a circle breathing system set to pressure-controlled ventilation. When the capnography monitor showed a square capnogram and no leakage around the device was heard, the insertion was defined as successful. After successful insertion of the device, insertion was scored as easy, satisfactory, or difficult. Leak pressure was measured up to a maximum inspiratory pressure of 40 mbar. Positioning of the device in relation to the larynx was visualized using a flexible bronchoscope and graded as demonstrated in Table 2. The supraglottic device was removed at the end of anesthesia in the operating room after which the patient was transferred to the postanesthesia care unit. Patients were interviewed by trained recovery personnel (blinded to the device used) at 1, 24, and 48 h postoperatively, either in the patient ward or at home by phone. Patients were asked about six specific postoperative complaints as listed in Table 3.

Table 2

Table 2

Table 3

Table 3

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Statistical Analysis

Sample size was calculated for a Type I error of 0.05 and a power of 0.80 on unpublished data from the manufacturer of the i-gel, demonstrating an incidence rate of postoperative sore throat of 10.5% using the i-gel and an incidence2 of 22.6% using the classic LM. Statistical analysis was performed using an analysis of variance test for demographic (parametric) data and the Mann-Whitney U-test for all test results (nonparametric data).

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RESULTS

Two hundred forty-six patients were asked to participate in this study. Two patients refused and therefore 244 patients were randomized to one of the two study arms. Twenty-six patients did not receive surgical treatment in our hospital. This resulted in 111 patients in the i-gel group and 107 in the LM group. Demographic data are displayed in Table 1. Statistical analysis revealed no significant differences between the groups.

Table 1

Table 1

There were no significant differences in number of attempts of insertions of the devices or failure to insert either device. A shorter mean time to insertion, higher mean leak pressure, incidence of maximum seal pressure, and better fiberoptic view score were demonstrated for the i-gel group versus the LM group. Other perioperative data and perioperative complications revealed no significant differences. Relevant perioperative data are displayed in Table 2.

There was a higher incidence of sore throat and dysphagia at 1, 24, and 48 h in the LM group compared with the i-gel group. Neck pain was also more common at 24 and 48 h in the LM group. The incidence of postoperative complaints in both groups is shown in Table 3.

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DISCUSSION

This study demonstrates a significant reduction of postoperative sore throat and dysphagia complaints for the i-gel, when compared with La Premiere LM airway. The percentages of complaints for the i-gel are also lower than for other supraglottic devices in different studies,2–6 with the exception of dysphagia complaints for the LMA-Unique® 2 h postoperatively.4 Although the La Premiere is a standard LM airway, we cannot conclude from these data that the i-gel will reproduce similar results when compared with other supraglottic devices because all devices were not compared within one single-study protocol. The main limitation of this study is the use of a standardized cuff volume for the LM instead of cuff inflation to a predetermined pressure. We cannot exclude that there could be a lower incidence of throat and neck complaints in a standard LM airway using a recommended cuff inflation to a pressure of 40-60 cm H2O. The high percentage of women with cancer is another limitation of this study, because an ambulatory surgery study demonstrated a higher incidence of postoperative sore throat in female patients than in male patients.7 Another limitation concerns the functionality variables of the devices. These data were obtained by the anesthesiologist who inserted the device, therefore introducing possible bias. Future studies should therefore focus on objective and blinded measurement of these variables.

We conclude that, in this randomized study, the i-gel supraglottic device resulted in a lower incidence of throat and neck complaints than the La Premiere LM airway.

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REFERENCES

1. McHardy FE, Chung F. Postoperative sore throat: cause, prevention and treatment. Anaesthesia 1999;54:444–53
2. Brimacombe J, Keller C, Fullekrug B, Agro F, Rosenblatt W, Dierdorf SF, Garcia de Lucas E, Capdevilla X, Brimacombe N. A multicenter study comparing the ProSeal and Classic laryngeal mask airway in anesthetized, nonparalyzed patients. Anesthesiology 2002;96:289–95
3. Brimacombe JR, Brimacombe JC, Berry AM, Morris R, Mecklem D, Clarke G, Barry J, Kirk T. A comparison of the laryngeal mask airway and cuffed oropharyngeal airway in anesthetized adult patients. Anesth Analg 1998;87:147–52
4. van Zundert A, Al Shaikh B, Brimacombe J, Koster J, Koning D, Mortier EP. Comparison of three disposable extraglottic airway devices in spontaneously breathing adults: the LMA-Unique, the Soft Seal laryngeal mask, and the Cobra perilaryngeal airway. Anesthesiology 2006;104:1165–9
5. Van Zundert AA, Fonck K, Al Shaikh B, Mortier E. Comparison of the LMA-classic with the new disposable soft seal laryngeal mask in spontaneously breathing adult patients. Anesthesiology 2003;99:1066–71
6. Timmermann A, Cremer S, Eich C, Kazmaier S, Brauer A, Graf BM, Russo SG. Prospective clinical and fiberoptic evaluation of the Supreme laryngeal mask airway. Anesthesiology 2009;110:262–5
7. Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth 2002;88:582–4
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