Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices

Prince of Songkla University

Status: Completed

Conditions: Complication of Device Insertion; Appropriate Affect

Treatments: Drug: Propofol Fresenius

Study type: Interventional

Funder types: Other

Identifiers

NCT04664595

55-213-08-1-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 4 patient groups

Group SP

Sham Comparator group

Description:

The Supreme™ group

Treatment:

Drug: Propofol Fresenius

Group PS

Active Comparator group

Description:

The ProSeal™ group

Treatment:

Drug: Propofol Fresenius

Group IG

Active Comparator group

Description:

The I-gel™ group

Treatment:

Drug: Propofol Fresenius

Group LT

Active Comparator group

Description:

The Laryngeal Tube Suction IITM group

Treatment:

Drug: Propofol Fresenius