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

NCT02001285 | Unknown

• 1 other identifier: HJKim2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation, Intratracheal

Keywords

remifentanil

Outcome Measures

Primary Outcomes (1)

• arterial blood pressure

  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 Outcomes (1)

• heart rate

  Change from baseline in heart rate at intubation period

Study Arms (2)

Double lumen tube

EXPERIMENTAL

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

single lumen tube

ACTIVE COMPARATOR

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

Interventions

Remifentanil DRUG

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

Also known as: Ultiva (TM)

Double lumen tube; single lumen tube

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patient who is needed intubation for general anesthesia

You may not qualify if:

• patient who is anticipating difficult airway
• patient who takes any drug to influence this study
• cardiovascular disease, renal disease, liver disease

Sponsors & Collaborators

• Jeju National University School of Medicine: lead

Study Sites (1)

Jeju National University Hospital

Jeju City, Jeju Special Self-Governing Province, 690-767, South Korea

RECRUITING

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hyun Jung Kim, MD, PhD

CONTACT

82-64-717-2026; hjanesthesia@empas.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: December 4, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 4, 2013

Record last verified: 2013-11

Locations

KR (1)