Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices

Complication of Device Insertion Clinical Trial

Official title:

Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664595
• Other study ID #: 55-213-08-1-2
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: August 2021
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Appropriate Affect
• Complication of Device Insertion

Intervention

Drug:
• Propofol Fresenius
final dose of Propofol (mcg/kg) to reach the target effect-site concentration

Locations

Country	Name	City	State
Thailand	Price of Songkla University	Hat Yai	Songkhla
Thailand	Songklanagarind Hospital	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of propofol for supragloqtic airway devices insertion	The effect-site concentration of propofol required to insert supraglottic airway devices.	2 years
Secondary	Blood pressure changes from baseline after insertion of supraglottic devices		2 years