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Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices

Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04664595
Enrollment
40
Registered
2020-12-11
Start date
2012-06-30
Completion date
2013-12-31
Last updated
2021-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appropriate Affect, Complication of Device Insertion

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

Prince of Songkla University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

double blinded

Intervention model description

4 second generation of supraglottic airway device

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Tolerability of propofol for supragloqtic airway devices insertion2 yearsThe effect-site concentration of propofol required to insert supraglottic airway devices.

Secondary

MeasureTime frame
Blood pressure changes from baseline after insertion of supraglottic devices2 years

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026