Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
to evaluate and compare the effect-site concentration of propofol with the TCI system for second-generation SGA device insertion between the I-gelâ„¢, Supremeâ„¢, ProSealâ„¢ and Laryngeal Tube Suction IIâ„¢.
to determine the hemodynamic changes during insertion of supraglottic devices in patients undergoing elective surgery and any complications after device insertion.
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-gelâ„¢, Supremeâ„¢, ProSealâ„¢ and Laryngeal Tube Suction IIâ„¢ 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group SP | Sham Comparator | The Supremeâ„¢ group |
|
| Group PS | Active Comparator | The ProSealâ„¢ group |
|
| Group IG | Active Comparator | The I-gelâ„¢ group |
|
| Group LT | Active Comparator | The Laryngeal Tube Suction IITM group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol Fresenius | Drug | final dose of Propofol (mcg/kg) to reach the target effect-site concentration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of propofol for supragloqtic airway devices insertion | The effect-site concentration of propofol required to insert supraglottic airway devices. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure changes from baseline after insertion of supraglottic devices | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Price of Songkla University | Hat Yai | Changwat Songkhla | 90110 | Thailand | ||
| Songklanagarind Hospital |
Not provided
| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
4 second generation of supraglottic airway device
Not provided
Not provided
double blinded
| Hat Yai |
| Changwat Songkhla |
| 90110 |
| Thailand |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |