The EC50 of Remifentanil Blunting Hemodynamic Response to Double Lumen Tube Intubation

NCT ID: NCT01542099

Last Updated: 2016-04-20

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the effect site concentration of remifentanil blunting hemodynamic changes to tracheal intubation of single or double lumen tubes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodynamic Responses During Tracheal Intubation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single lumen tube

Single lumen tube intubation during remifentanil infusion

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

According to previous patient's response, the investigators will allocate the effect site concentration of remifentanil of next patient during single lumen tube intubation. For this allocation of dose of remifentanil the investigators use up-and-down method.

For the first patient, the dose of remifentanil would be fixed at 6.0 ng/ml which we predict as EC50. Step size of dose is 0.5ng/ml.

Double lumen tube

Double lumen tube intubation during remifentanil infusion

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

According to previous patient's response, the investigators will allocate the effect site concentration of remifentanil of next patient during double lumen tube intubation. For this allocation of dose of remifentanil the investigators use up-and-down method.

For the first patient, the dose of remifentanil would be fixed at 6.0 ng/ml which we predict as EC50. And, step size of dose is 0.5ng/ml.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remifentanil

According to previous patient's response, the investigators will allocate the effect site concentration of remifentanil of next patient during double lumen tube intubation. For this allocation of dose of remifentanil the investigators use up-and-down method.

For the first patient, the dose of remifentanil would be fixed at 6.0 ng/ml which we predict as EC50. And, step size of dose is 0.5ng/ml.

Intervention Type DRUG

Remifentanil

According to previous patient's response, the investigators will allocate the effect site concentration of remifentanil of next patient during single lumen tube intubation. For this allocation of dose of remifentanil the investigators use up-and-down method.

For the first patient, the dose of remifentanil would be fixed at 6.0 ng/ml which we predict as EC50. Step size of dose is 0.5ng/ml.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing thoracic surgery that require one lung ventilation

Exclusion Criteria

* patient who does not agree with this study
* BMI \< 16.0 or BMI \> 30
* cardiovascular disease, pulmonary disease, renal disease
* alcoholic abuser or drug abuser
* patient who takes any drug to influence cardiovascular system or sympathetic nervous system
* any use of local anesthetics or drugs to influence cardiovascular system during tracheal intubation
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jae-Hyon Bahk, MD, PhD

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

Kim TK, Hong DM, Lee SH, Paik H, Min SH, Seo JH, Jung CW, Bahk JH. Effect-site concentration of remifentanil required to blunt haemodynamic responses during tracheal intubation: A randomized comparison between single- and double-lumen tubes. J Int Med Res. 2018 Jan;46(1):430-439. doi: 10.1177/0300060517721072. Epub 2017 Jul 21.

Reference Type DERIVED
PMID: 28730932 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JHBahk_DLT_remi

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.