NCT04664595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
6.3 years until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

September 2, 2014

Last Update Submit

August 20, 2021

Conditions

Appropriate AffectComplication of Device Insertion

Keywords

Target Controlled InfusionSupraglottic airway devicePropofolSupreme™ProSeal™I-gel™Laryngeal Tube Suction II™

Outcome Measures

Primary Outcomes (1)

  • Tolerability of propofol for supragloqtic airway devices insertion

    The effect-site concentration of propofol required to insert supraglottic airway devices.

    2 years

Secondary Outcomes (1)

  • Blood pressure changes from baseline after insertion of supraglottic devices

    2 years

Study Arms (4)

Group SP

SHAM COMPARATOR

The Supreme™ group

Drug: Propofol Fresenius

Group PS

ACTIVE COMPARATOR

The ProSeal™ group

Drug: Propofol Fresenius

Group IG

ACTIVE COMPARATOR

The I-gel™ group

Drug: Propofol Fresenius

Group LT

ACTIVE COMPARATOR

The Laryngeal Tube Suction IITM group

Drug: Propofol Fresenius

Interventions

Propofol FreseniusDRUG

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

Group IGGroup LTGroup PSGroup SP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I-III patients.
  • Patients 18-70 years old .
  • Patients scheduled for general anesthesia for elective non-cardiac surgery with SGA devices.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Price of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 4 second generation of supraglottic airway device
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 2, 2014

First Posted

December 11, 2020

Study Start

June 1, 2012

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

August 23, 2021

Record last verified: 2021-08

Locations

TH(2)