Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices
Condition: Appropriate Affect; Complication of Device Insertion
Study type: Interventional

Summary: 
      to evaluate and compare the effect-site concentration of propofol with the TCI system for
      second-generation SGA device insertion between the I-gel™, Supreme™, ProSeal™ and Laryngeal
      Tube Suction II™.

      to determine the hemodynamic changes during insertion of supraglottic devices in patients
      undergoing elective surgery and any complications after device insertion.
    

Detailed description: 
      The investigators enrolled ASA physical status I-III patients who were 18-70 years old and
      scheduled for general anesthesia for elective non-cardiac surgery with SGA devices.Adults
      with a potentially difficult airway (cervical spine disease, Mallampati classification IV, or
      a mouth opening less than 2.5 cm.), reactive airway disease, signs of respiratory infection
      or a plan to remain intubated were excluded from the study. The investigators also excluded
      patients who had a risk of gastric aspiration or morbid obesity (body mass index > 35 kg/m2).

      Patients were randomized into 4 groups (I-gel™, Supreme™, ProSeal™ and Laryngeal Tube Suction
      II™ SGAs) according to a computer generated randomization list and patients were allocated
      consecutively. The sample size of each group required 10 patients.

      All patients were pre-oxygenated with 100% oxygen. After the administration of 2 µg/ml
      intravenous fentanyl for 5 minutes, anesthesia was induced with the Schnider pharmacokinetic
      TCI system. After equilibration of the plasma-site and effect-site concentrations in propofol
      TCI, 1 of the 4 types of SGA was randomly inserted by two anesthesiologists (resident trainee
      and staff doctor) who were unaware of the actual plasma concentration of propofol without the
      use of a muscle relaxant.

      The response of each patient determined the effect-site concentration of propofol of the next
      patient. "No Response" was defined as Laryngeal Mask Airway Insertion Score = 0 and
      "Response" was defined as Laryngeal Mask Airway Insertion Score ≥ 1. If the insertion of the
      supraglottic airway device was successful ("No Response"), then the target effect-site
      concentration was decreased by a step of 0.4 µg/ml. If the insertion failed ("Response"), the
      target effect-site concentration was increased by the same dose. The patients' responses to
      LMA insertion was classified by blinded investigators.
    

Intervention name(s): Propofol Fresenius
Intervention type(s): Drug
Intervention description(s): final dose of Propofol (mcg/kg) to reach the target effect-site concentration
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 second generation of supraglottic airway device
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Target Controlled Infusion; Supraglottic airway device; Propofol; Supreme™; ProSeal™; I-gel™; Laryngeal Tube Suction II™