EC95 of Remifentanil for Preventing Cough

June 8, 2017 updated by: Jong Yeop Kim, Ajou University School of Medicine

Predicted EC95 of Effect-site Concentration of Remifentanil for Preventing Cough After Laryngomicrosurgery From Propofol Anesthesia

The investigator designed this study to investigate remifentanil effect-site concentration in 95% of patients (EC95) for preventing cough after laryngomicrosurgery 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). Extubation 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)

40

Phase

  • Not Applicable

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
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 443-721
        • Ajou University Hospital

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-II patients undergoing general anesthesia for laryngomicrosurgery

Exclusion Criteria:

  • Anticipated difficult airway
  • COPD, Asthma
  • Recent URI (< 2 weeks)
  • Severe cardiac, hepatic renal disease

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Remifentanil
Extubation was performed when remifentanil was maintained a predetermined concentration throughout the emergence periods.
Drug: Remifentanil
The concentration of remifentanil was determined by biased-coin up and down design, starting from 1.0 ng/ml (0.4 ng/ml as a step size)
Other Names:
  • Ultiva
Drug: Propofol anesthesia
Anesthesia was induced with propofol target-controlled infusion at an effect-site concentration of 5.0 μg/ml.
Other Names:
  • Fresofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cough
Time Frame: from end of surgery to 5 min after tracheal extubation
Number of cough or a strong and sudden contraction of the abdomen during periextubation periods
from end of surgery to 5 min after tracheal extubation

Collaborators and Investigators

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

Sponsor

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 (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

November 21, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (ESTIMATE)

November 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-CT4-16-349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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