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

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ClinicalTrials.gov Identifier: NCT01542099
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):

February 9, 2012
March 2, 2012
April 20, 2016
November 2011
April 2012   (Final data collection date for primary outcome measure)
Changes from baseline in heart rate and mean arterial pressure after intubation [ Time Frame: intubation period ]
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.
Same as current
Complete list of historical versions of study NCT01542099 on ClinicalTrials.gov Archive Site
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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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Hemodynamic Responses During Tracheal Intubation
  • 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: Single lumen tube
    Single lumen tube intubation during remifentanil infusion
    Intervention: Drug: Remifentanil
  • Active Comparator: Double lumen tube
    Double lumen tube intubation during remifentanil infusion
    Intervention: Drug: Remifentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01542099
JHBahk_DLT_remi
Yes
Not Provided
Not Provided
Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP