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Randomized comparison of the i-gelTM with the LMA SupremeTM in anesthetized adult patients

Randomisierter Vergleich von i-gelTMund LMA SupremeTM bei narkotisierten erwachsenen Patienten

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Abstract

Background

The LMA SupremeTM (LMA-S) and i-gelTM are two of the most commonly used supraglottic airway devices (SADs) with an inbuilt drain channel. These devices are particularly indicated for performing certain procedures accompanied by high peak airway pressure, such as laparoscopy. This study compared the devices regarding efficacy, safety, ease of use and incidence of adverse events, focusing on the postoperative rate of sore throat, dysphagia or dysphonia and development with time, in patients undergoing laparoscopic cholecystectomy procedures under general anesthesia.

Methods

This was a prospective, randomized, controlled clinical study including 140 patients randomized into 2 groups undergoing elective laparoscopic cholecystectomy to use either i-gel or LMA-S. After the general anesthesia procedure, the speed of insertion, success rates, ease of insertion of the drain tube, leak pressure and tidal volume achieved by the devices were evaluated. The postoperative oropharyngeal discomfort (POPD) during the period of stay of the patients in the recovery room was also recorded.

Results

The mean leak pressure was comparable between the two groups (i-gel 28.18 ± 3.90 cmH2O and LMA-S 27.50 ± 4 cmH2O, p = 0.09), as well as maximum expiratory tidal volume provided (i-gel 559.60 ± 45.25 ml and LMA-S 548.95 ± 56.18 ml, p = 0.12). Insertion times were lower for the i-gel (10 ± 1.62 s) compared with the LMA-S (11.31 ± 2.85 s, p = 0.008). Insertion success rate at the first attempt was higher for the LMA-S (95 % compared with i-gel 79 %, p = 0.007). Drain tubes were easier to insert in the LMA-S group (p < 0.001). No differences were found between groups relating to intraoperative complications. Frequency of coughing and visible blood on removal of the device were low and comparable in both groups (p = 0.860 and p = 0.623, respectively). There were no differences relating to the incidence of sore throat, dysphagia or hoarseness at 10 min postoperatively between groups (p = 0.088). The i-gel group complained about a higher sore throat score at 2 h postoperatively (p = 0.009), specifically patients receiving i-gel suffered more from sore throats with 0.24 more points on the visual analog scale (VAS) than patients from the LMA-S group. The i-gel group also reported a lower POPD drop during the first 2 h (p < 0.001).

Conclusion

No differences were found between i-gel and LMA-S regarding leak pressure in the groups of anesthetized patients undergoing laparoscopic cholecystectomy. The LMA-S was easier to insert than the i-gel (based on its better first time success rate) and this device showed better ease of drain tube insertion, although the i-gel was quicker to insert than the LMA-S. The i-gel resulted in higher sore throat scores at 2 h postoperatively and lower POPD reduction during the 2 h period studied in the recovery room was reported.

Zusammenfassung

Hintergrund

LMA SupremeTM (LMA-S) und i-gelTM sind 2 der am häufigsten verwendeten supraglottischen Beatmungsgeräte mit eingebautem Magensaftablaufkanal. Sie sind besonders indiziert bei Interventionen, bei denen es zu hohen Spitzen im Atemwegsdruck kommt, etwa bei Laparoskopien. In der Studie wurden Wirksamkeit, Sicherheit, Benutzerfreundlichkeit und die Inzidenz von unerwünschten Ereignissen verglichen. Besondere Beachtung erfuhren dabei die Raten an postoperativ auftretenden Halsschmerzen, Dysphagie oder Dysphonie und der Entwicklung im zeitlichen Verlauf bei Patienten nach laparoskopischer Cholezystektomie in Allgemeinnarkose.

Methoden

In die prospektive, kontrollierte klinische Studie wurden 140 Patienten aufgenommen, die sich einer elektiven laparoskopischen Cholezystektomie unterzogen; sie wurden randomisiert auf 2 Gruppen und mit i-gel oder LMA-S intubiert. Nach Allgemeinanästhesie wurden evaluiert: Geschwindigkeit der Einführung, Erfolgsraten, Benutzerfreundlichkeit hinsichtlich der Einführung der Magensonde über den Ablaufkanal, Dichtheitsdruck und Atemvolumen. Darüber hinaus wurden postoperative oropharyngeale Beschwerden („postoperative oropharyngeal discomfort“, POPD) der Patienten während des Aufenthalts im Aufwachraum dokumentiert.

Ergebnisse

Dichtheitsdruck (i-gel 28,18 ± 3,90; LMA-S 27,50 ± 4 cm H2O, p = 0,09) und maximales exspiratorisches Atemvolumen (i-gel 559,60 ± 45,25; LMA-S 548,95 ± 56,18 ml, p = 0,12) waren in beiden Gruppen vergleichbar. Die Einführungszeiten waren beim i-gel niedriger als beim LMA-S (10 ± 1,62 vs. 2,85 ± 11,31 s, p = 0,008). Die Einführungerfolgsquote beim ersten Versuch war höher beim LMA-S (95 % vs. i-gel: 79 %, p = 0,007). Die Platzierung einer Magensonde über den Ablaufkanal wurde als einfacher in der LMA-S-Gruppe (p < 0,001) beurteilt. Hinsichtlich intraoperativer Komplikationen wurden keine Gruppenunterschiede beobachtet. Husten und Blutspuren bei Entfernung der Geräte waren selten und in beiden Gruppen vergleichbar (p = 0,860 bzw. p = 0,623). Zehn Minuten postoperativ gab es keine Gruppenunterschiede (p = 0,088) in der Inzidenz von Halsschmerzen, Dysphagie und Heiserkeit. In der i-gel-Gruppe zeigten sich höhere Werte in den Angaben zu Halsschmerzen 2 h postoperativ (p = 0,009), vor allem litten die i-gel-Patienten mehr an Halsschmerzen (0,24 mehr auf der visuellen Analogskala, VAS) als die Patienten der LMA-S-Gruppe. In der i-gel-Gruppe verringerten sich die POPD in den ersten 2 postoperativen Stunden weniger (p < 0,001).

Schlussfolgerungen

Zwischen i-gel und LMA-S wurden im Hinblick auf den Dichtheitsdruck keine Unterschiede gefunden. LMA-S war leichter einzuführen als i-gel (auf der Basis der besseren initialen Erfolgsrate), und bei diesem Geräte war das Einführen der Magensonde leichter, auch wenn i-gel schneller einzusetzen waren als LMA-S. Nach i-gel wurden 2 h postoperative höhere Halsschmerzenscores angegeben und eine geringere POPD-Verringerung während der 2 h im Aufwachraum.

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Acknowledgements

The authors would like to thank Sebastian Fairhurst for help and support in translating the English abstract text into German.

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Authors and Affiliations

  1. Department of Anesthesiology and Critical Care, Sureste University Hospital, 28500, C/Ronda del Sur, 10, Arganda del Rey, Madrid, Spain

    J.M. Beleña M.D., Ph.D., A. Alcojor M.D. & J.L. Pérez M.D.

  2. Department of Anesthesiology and Critical Care, Ramón y Cajal University Hospital, Madrid, Spain

    M. Núñez M.D. & P. Lee MD

  3. Anesthesiology and Resuscitation Unit, Department of Pharmacology, Faculty of Medicine, Complutense University, Madrid, Spain

    A. Vidal M.D., Ph.D. & C. Gasco M.D., Ph.D.

Authors
  1. J.M. Beleña M.D., Ph.D.
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  2. M. Núñez M.D.
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  3. A. Vidal M.D., Ph.D.
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  4. C. Gasco M.D., Ph.D.
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  5. A. Alcojor M.D.
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  6. P. Lee MD
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  7. J.L. Pérez M.D.
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Corresponding author

Correspondence to J.M. Beleña M.D., Ph.D..

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Conflict of interest

J.M. Beleña, M. Núñez, A. Vidal, C. Gasco, A. Alcojor, P. Lee and J.L. Pérez state that there are no conflicts of interest. All studies on humans described in the present manuscript were carried out with the approval of the responsible ethics committee and in accordance with national law and the Helsinki Declaration of 1975 (in its current, revised form). Informed consent was obtained from all patients included in studies.

Disclosure of funding

No funds were received for the study from any of the following organizations: National Institutes of Health (NIH), Spanish Society of Anaesthesiology (SSAR), Regional Government of Madrid (RGM), neither from other organization, including departmental or institutional funding.

Clinical trial registry

This trial was not registered in any public registry due to the starting date for patient enrolment (September 2009).

Additional information

Author contributions:

J.M. Beleña: study conception and design, acquisition of data, analysis and interpretation of data, drafting of manuscript and critical revision.

M. Nuñez: study conception and design, acquisition of data, drafting of manuscript and critical revision.

A. Vidal: study conception and design, analysis and interpretation of data, drafting of manuscript and critical revision.

C. Gasco: study conception and design, drafting of manuscript and critical revision.

A. Alcojor: acquisition of data, drafting of manuscript and critical revision.

P. Lee: analysis and interpretation of data, drafting of manuscript and critical revision.

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Beleña, J., Núñez, M., Vidal, A. et al. Randomized comparison of the i-gelTM with the LMA SupremeTM in anesthetized adult patients. Anaesthesist 64, 271–276 (2015). https://doi.org/10.1007/s00101-015-0020-z

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  • DOI: https://doi.org/10.1007/s00101-015-0020-z

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