Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices

Study Overview
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Brief Summary
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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
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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.

Official Title
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Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices

Conditions
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Appropriate Affect, Complication of Device Insertion

Intervention / Treatment
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* Drug: Propofol Fresenius


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 second generation of supraglottic airway device
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group SP<br>The Supreme™ group | Drug: Propofol Fresenius<br>* final dose of Propofol (mcg/kg) to reach the target effect-site concentration<br>|
| Active Comparator: Group PS<br>The ProSeal™ group | Drug: Propofol Fresenius<br>* final dose of Propofol (mcg/kg) to reach the target effect-site concentration<br>|
| Active Comparator: Group IG<br>The I-gel™ group | Drug: Propofol Fresenius<br>* final dose of Propofol (mcg/kg) to reach the target effect-site concentration<br>|
| Active Comparator: Group LT<br>The Laryngeal Tube Suction IITM group | Drug: Propofol Fresenius<br>* final dose of Propofol (mcg/kg) to reach the target effect-site concentration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure changes from baseline after insertion of supraglottic devices |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Target Controlled Infusion, Supraglottic airway device, Propofol, Supreme™, ProSeal™, I-gel™, Laryngeal Tube Suction II™