Appropriate Affect, Complication of Device Insertion
Conditions
Keywords
Target Controlled Infusion, Supraglottic airway device, Propofol, Supreme™, ProSeal™, I-gel™, Laryngeal Tube Suction II™
Brief 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.
Interventions
final dose of Propofol (mcg/kg) to reach the target effect-site concentration
Sponsors
Study design
Masking description
double blinded
Intervention model description
4 second generation of supraglottic airway device
Eligibility
Inclusion criteria
* ASA physical status I-III patients. * Patients 18-70 years old . * Patients scheduled for general anesthesia for elective non-cardiac surgery with SGA devices.
Exclusion criteria
* Adults with a potentially difficult airway (cervical spine disease, Mallampati classification IV, or a mouth opening less than 2.5 cm.). * Adults with reactive airway disease. * Adults with signs of respiratory infection or a plan to remain intubated were excluded from the study. * Excluded patients who had a risk of gastric aspiration or morbid obesity (body mass index \> 35 kg/m2).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of propofol for supragloqtic airway devices insertion | 2 years | The effect-site concentration of propofol required to insert supraglottic airway devices. |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure changes from baseline after insertion of supraglottic devices | 2 years |
Countries
Thailand