Effect-site Concentration of Remifentanil for Blunting Hemodynamic Responses to Double-lumen Endobronchial Intubation

November 27, 2013 updated by: Hyun Jung Kim, Jeju National University School of Medicine

Comparison of the Effect-site Concentration of Remifentanil for Blunting Hemodynamic Responses to Ordinary Tracheal and Double-lumen Endobronchial Intubation During Propofol-remifentanil Total Intravenous Anesthesia

The purpose of this study is the comparison of the effect-site concentration of remifentanil for blunting hemodynamic responses to ordinary tracheal and double-lumen endobronchial intubation during propofol-remifentanil total intravenous anesthesia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

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 Contact

Study Locations

  • Korea, Republic of
    • Jeju Special Self-Governing Province
      • Jeju-si, Jeju Special Self-Governing Province, Korea, Republic of, 690-767
        • Recruiting
        • Jeju National University Hospital
        • Contact:

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:

  • Adult patient who is needed intubation for general anesthesia

Exclusion Criteria:

  • patient who is anticipating difficult airway
  • patient who takes any drug to influence this study
  • cardiovascular disease, renal disease, liver 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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double lumen tube
This arm contains patients who are needed endobronchial intubation with double lumen tube for general anesthesia. After propofol infusion of effect site concentration 4 μg/ml, remifentanil infusion will be started with effect site concentration of 3.5 ng/ml. According to change arterial blood pressure and heart rate from baseline value, next remifentanil concentration will be regulated using up-and-down method. Step size of dose is 0.5 ng/ml.
Drug: Remifentanil
During intubation, remifentanil will be infused to prevent change arterial blood pressure and heart rate.
Other Names:
  • Ultiva (TM)
Active Comparator: single lumen tube
This arm contains patients who are needed endotracheal intubation with single lumen tube for general anesthesia. After propofol infusion of effect site concentration 4 μg/ml, remifentanil infusion will be started with effect site concentration of 3.5 ng/ml. According to change arterial blood pressure and heart rate from baseline value, next remifentanil concentration will be regulated using up-and-down method. Step size of dose is 0.5 ng/ml.
Drug: Remifentanil
During intubation, remifentanil will be infused to prevent change arterial blood pressure and heart rate.
Other Names:
  • Ultiva (TM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arterial blood pressure
Time Frame: Change from baseline in arterial blood pressure at intubation period
Arterial blood pressure will be recorded before anesthesia, after propofol infusion, after remifentanil infusion and after intubation during 3 min with 1 min interval.
Change from baseline in arterial blood pressure at intubation period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: Change from baseline in heart rate at intubation period
Heart rate will be recorded before anesthesia, after propofol infusion, after remifentanil infusion and after intubation during 3 min with 1 min interval.
Change from baseline in heart rate at intubation period

Collaborators and Investigators

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

Sponsor

Jeju National 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 (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

October 28, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HJKim2

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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