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

NCT ID: NCT02001285

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Intubation, Intratracheal

Keywords

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remifentanil

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

During intubation, remifentanil will be infused to prevent change arterial blood pressure and heart rate.

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.

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

During intubation, remifentanil will be infused to prevent change arterial blood pressure and heart rate.

Interventions

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Remifentanil

During intubation, remifentanil will be infused to prevent change arterial blood pressure and heart rate.

Intervention Type DRUG

Other Intervention Names

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Ultiva (TM)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jeju National University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hyun Jung Kim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jeju National University Hospital

Jeju City, Jeju Special Self-Governing Province, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyun Jung Kim, MD, PhD

Role: CONTACT

Phone: 82-64-717-2026

Email: [email protected]

Facility Contacts

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Hyun Jung Kim, MD, PhD

Role: primary

Other Identifiers

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HJKim2

Identifier Type: -

Identifier Source: org_study_id