Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices

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.

Study Overview

• Status: Completed
• Conditions: Complication of Device Insertion; Appropriate Affect
• Intervention / Treatment: Drug: Propofol Fresenius

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • Songklanagarind Hospital
    • Hat Yai, Songkhla, Thailand, 90110
      • Price of Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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	Time Frame
Blood pressure changes from baseline after insertion of supraglottic devices	2 years

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Propofol; Supraglottic airway device; Target Controlled Infusion; Supreme™; ProSeal™; I-gel™; Laryngeal Tube Suction II™
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 55-213-08-1-2