Remifentanil for the I-gel and Laryngeal Mask Airway Insertion

October 13, 2015 updated by: Jong Yeop Kim, Ajou University School of Medicine

Comparison of the Effect-site Concentration of Remifentanil for Insertion of the I-gel and Laryngeal Mask Airway During Propofol Anesthesia

Structural differences of supraglottic airway devices could influence the different compressive forces in the oropharyngeal cavities, and require different depth of anesthesia. The addition of remifentanil during propofol anesthesia facilitates the insertion of laryngeal mask airway (LMA) with minimal adverse hemodynamic disturbances. This study was designed to determine the effect-site concentration of remifentanil in 50% of patients (EC50) and 95% of patients (EC95) for successful i- gel insertion, and compare those for LMA insertion during propofol target-controlled infusion (TCI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anesthesia was induced with propofol TCI at the effect-site concentration of 5 μg/ml, and the predetermined effect-site concentration of remifentanil was started simultaneously. The remifentanil concentration was determined using modified Dixon's up-and-down method (initial concentration: 3.0 ng/ml, step size: 0.5 ng/ml). Five minutes later, i- gel or LMA insertion was attempted. The response of the patients to the insertion of LMA was classified as either 'movement' or 'no movement'.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA I-II patients undergoing general anesthesia for short elective surgery (<2 hr)

Exclusion Criteria:

  • G-E reflux
  • obesity (BMI>30)
  • anticipated difficult airway

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: i-gel
I-gel insertion was attempted during propofol and remifentanil anesthesia .
Drug: remifentanil
The predetermined effect-site concentration of remifentanil was started using modified Dixon's up-and-down method
Other Names:
  • ultiva
Device: i-gel
I-gel insertion was inserted 5 min after anesthesia induction
Drug: propofol
Anesthesia was induced with propofol target-controlled infusion at the effect-site concentration of 5 μg/ml
Other Names:
  • fresofol
Active Comparator: laryngeal mask airway
LMA insertion was attempted during propofol and remifentanil anesthesia .
Drug: remifentanil
The predetermined effect-site concentration of remifentanil was started using modified Dixon's up-and-down method
Other Names:
  • ultiva
Drug: propofol
Anesthesia was induced with propofol target-controlled infusion at the effect-site concentration of 5 μg/ml
Other Names:
  • fresofol
Device: laryngeal mask airway
laryngeal mask airway insertion was inserted 5 min after anesthesia induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
successful insertion of i-gel and LMA
Time Frame: from 5 min after anesthetic induction to 1min after device insertion
from 5 min after anesthetic induction to 1min after device insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Investigators

  • Study Director: Jong Yeop Kim, MD, Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-CT4-14-417

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Supraglottic Airways for General Anesthesia

Clinical Trials on remifentanil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe