Clinical trial NCT04664595: Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices
Official title: Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appropriate Affect
Complication of Device Insertion
Keywords: Target Controlled Infusion
Supraglottic airway device
Propofol
Supreme™
ProSeal™
I-gel™
Laryngeal Tube Suction II™
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 second generation of supraglottic airway device
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Tolerability of propofol for supragloqtic airway devices insertion
timeFrame: 2 years
Secondary outcomes:
measure: Blood pressure changes from baseline after insertion of supraglottic devices
timeFrame: 2 years
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Price of Songkla University
state: Songkhla
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital
state: Songkhla
Study officials:
References: