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

The Effect Site Concentration of Remifentanil Blunting Hemodynamic Responses to Tracheal Intubation: Single Versus Double Lumen Tube

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Responses During Tracheal Intubation
• Intervention / Treatment: Drug: Remifentanil; Drug: Remifentanil

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single lumen tube; Single lumen tube intubation during remifentanil infusion	Drug: 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.; 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.
Active Comparator: Double lumen tube; Double lumen tube intubation during remifentanil infusion	Drug: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in heart rate and mean arterial pressure after intubation	Heart rate and mean arterial pressure will be recorded at 2 minutes before intubation, 1 minute before intubation, during intubation, 1 minute after intubation. The mean value of heart rate and mean arterial pressure before intubation will be regarded as the baseline values. If maximum heart rate or mean arterial pressure after intubation increased by >15% from baseline value, the response will be regarded as "fail" and increased concentration of remifentanil will be applied to next patient by up and down sequential method.	intubation period

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 9, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: JHBahk_DLT_remi