The Comparison of the Clinical Efficacy Between I-gel and LMA-Supreme, the Two Most Recently Developed Supraglottic Airway Devices, in Elderly Patients
Condition: The Elderly Patients Aged Between 65 and 85
Study type: Interventional

Summary: 
      Since the laryngeal mask airway (LMA) was designed and introduced into a clinical setting, a
      supraglottic airway device is widely used because it has advantages such as manipulation of
      the device when inserting it is easier than that of an endotracheal tube and it causes less
      postoperative sore throats. Insertion of an LMA can be performed relatively easily and safety
      at an appropriate depth of anesthesia when compared with the insertion of an endotracheal
      tube because an LMA is inserted without using a laryngoscope and without causing stimulus to
      the vocal cords and the trachea. Hence, an LMA may be useful in cases of coronary artery
      disease and a carotid endarectomy where stabilization of the cardiopulmonary function is
      important. In addition, an LMA is hemodynamically stable not only in the induction of
      anesthesia but also in the arousal of anesthesia and thus less dangerous to a cardiovascular
      disease patient. LMA may be useful also to patients having chronic obstructive lung disease
      because the patients have an excessively sensitive airway and ventilation is difficult to
      perform in them. Therefore, in elderly patients having a prevalence for cardiovascular
      disease or chronic obstructive lung disease, use of an LMA, which stimulates the airway less,
      may provide hemodynamical stability and reduce relevant complications or side effects. LMA
      Supreme which is newly designed in such ways has been proven to be superior to the
      conventional LMA Classic in terms of easy insertion and oropharyngeal sealing. A study which
      compared LMA Classic and LMA Supreme with adult subjects showed that LMA Supreme had a
      superior insertion success rate and better oropharyngeal leak pressure (OLP) than those of
      LMA Classic. Another newly developed supraglottic airway device is I-gel. In I-gel, which is
      a disposable, latex-free LMA, a soft, gel-type cuff made of a thermoplastic elastomer
      replaces the inflatable cuff of other LMAs. Thus, I-gel has an advantage that, once it is
      installed, it requires no additional clinical manipulation such as cuff inflation or cuff
      pressure monitoring. A comparison of I-gel with LMA Classic and other disposable supraglottic
      airway devices produced by various manufactures in adult subjects showed that the clinical
      properties were similar with respect to easy insertion, time required for installation,
      laryngopharynx leak pressure, and degree of glottis exposure observed with a fiberoptic
      bronchoscope. Thus, I-gel is expected to be a supraglottic airway device which may replace
      the conventional LMA Classic. The elderly are known to have an upper airway anatomically
      different from that of younger adults depending on age. A study conducted with CT showed that
      normal elderly people had a wider upper airway than that of younger males or middle-aged
      males and that elderly with accompanying sleep apnea had a wider upper airway than that of
      younger males in all regions including the nasopharynx, oropharynx, and hypopharynx.
      Therefore, because the upper airway of the elderly is wider and longer, a different
      supraglottic airway device guide may be necessary. Our previous studies showed that the
      single time success rate was significantly lower, the insertion was more difficult, and the
      insertion took a longer time when the LMA classic was used in elderly patients than in
      younger adult patients. However, there is no available guide for the use of a supraglottic
      airway device or for a supraglottic airway device more appropriate for elderly patients.
      Moreover, no study has been ever conducted with regard to such a guide.

      Therefore, in this study, the clinical usefulness of I-gel and LMA Supreme, which are the
      newest supraglottic airway devices, was verified in elderly patients. It was also verified
      which of the two devices is better to use as a supraglottic airway device.
    


Intervention name(s): I-gel; Supreme-LMA
Intervention type(s): Device; Device
Intervention description(s): The patient was monitored at 1-5 minute intervals.
While supplying oxygen through a mask, propofol 1.0mg/kg and remifentanil 0.5ug/kg were intravenously injected to induce anesthesia. When consciousness was not lost, propofol 0.5mg/kg was additionally injected. After consciousness was lost and spontaneous respiration disappeared, rocuronium 0.3 mg/kg was intravenously injected while performing manual ventilation.
After injecting an anesthetic and muscle relaxant, the injection concentration of fresh gas including 6 L/min oxygen and desflurane was regulated to maintain BIS between 40 and 60. A train of four (TOF) was performed with a nerve stimulator for muscle relaxation monitoring to verify that a muscular contraction did not take place (TOF=0).
Then, with the assistance of another anesthesiologist, I-gel prepared in advance was inserted.; The patient was monitored at 1-5 minute intervals.
While supplying oxygen through a mask, propofol 1.0mg/kg and remifentanil 0.5ug/kg were intravenously injected to induce anesthesia. When consciousness was not lost, propofol 0.5mg/kg was additionally injected. After consciousness was lost and spontaneous respiration disappeared, rocuronium 0.3 mg/kg was intravenously injected while performing manual ventilation.
After injecting an anesthetic and muscle relaxant, the injection concentration of fresh gas including 6 L/min oxygen and desflurane was regulated to maintain BIS between 40 and 60. A train of four (TOF) was performed with a nerve stimulator for muscle relaxation monitoring to verify that a muscular contraction did not take place (TOF=0).
Then, with the assistance of another anesthesiologist, Supreme LMA prepared in advance was inserted.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Supraglottic airway device; I-gel; SupremeLMA; Elderly patient