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Completed

NCT Number: NCT01542099

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

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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Key information

Conditions

Hemodynamic Responses During Tracheal Intubation

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 2, 2012
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.