Dosing Study of Remifentanil for Smooth Removal of the Laryngeal Mask Airway (LMA)

October 13, 2014 updated by: Jong Yeop Kim, Ajou University School of Medicine

Effect-site Concentration of Remifentanil for Smooth Removal of the LMA From Propofol Anesthesia

The investigators attempted to determine the optimal effect-site concentration of remifentanil for smooth removal of the LMA from propofol anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to predetermined (initial concentration 1.0 ng/ml for the first patient). LMA removal was performed when the patients opened their eyes and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed.

Study Type

Interventional

Enrollment (Actual)

27

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

  • Korea, Republic of
      • Suwon, Korea, Republic of, 443-721
        • Ajou University School of Medicine

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-II patients undergoing general anesthesia for short elective surgery (<1 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: remifentanil
LMA removal was accomplished when remifentanil was maintained a predetermined concentration throughout the emergence periods.
Drug: remifentanil
The concentration of remifentanil was determined by modified Dixon's up-and-down method, starting from 1.0 ng/ml (0.2 ng/ml as a step size)
Other Names:
  • Ultiva
Device: laryngeal mask airway (LMA)
LMA was removed when the patients opened their eyes, and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
smooth removal of LMA
Time Frame: from end of surgery to removal of LMA (participants will be followed for the emergence periods, an expected average of 15 min).
the response of patients to the removal of LMA (classified as either 'success [smooth emergence]' or 'failure') during infusion of remifentanil.
from end of surgery to removal of LMA (participants will be followed for the emergence periods, an expected average of 15 min).

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

October 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 13, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-CT4-13

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.

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