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

Intubation, Intratracheal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02001285
• Other study ID #: HJKim2
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2013
• Last updated: November 27, 2013
• Start date: October 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2013
• Source: Jeju National University School of Medicine
• Contact: Hyun Jung Kim, MD, PhD
• Phone: 82-64-717-2026
• Email: hjanesthesia[@]empas.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intubation, Intratracheal

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Jeju National University Hospital	Jeju-si	Jeju Special Self-Governing Province

Sponsors (1)

Lead Sponsor	Collaborator
Jeju National University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	heart rate	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	Yes