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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01542099
First received: February 9, 2012
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Hemodynamic Responses During Tracheal Intubation
Drug: Remifentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect Site Concentration of Remifentanil Blunting Hemodynamic Responses to Tracheal Intubation: Single Versus Double Lumen Tube

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Changes from baseline in heart rate and mean arterial pressure after intubation [ Time Frame: intubation period ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: November 2011
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.


  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542099

Contacts
Contact: Jae-Hyon Bahk, MD, PhD 82-2-2072-2818 bahkjh@snu.ac.kr
Contact: Deok Man Hong, clinical instructor 82-2-2072-2469 mellyn7@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jae-Hyon Bahk, PhD, MD    82-2-2072-2818    bahkjh@snu.ac.kr   
Contact: Deok Man Hong, PhD, MD    82-2-2072-2469    mellyn7@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Jae-Hyon Bahk, MD, PhD, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01542099     History of Changes
Other Study ID Numbers: JHBahk_DLT_remi
Study First Received: February 9, 2012
Last Updated: July 8, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014