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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01542099
Enrollment
80
Registered
2012-03-02
Start date
2011-11-30
Completion date
2012-12-31
Last updated
2016-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Responses During Tracheal Intubation

Brief summary

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.

Interventions

DRUGRemifentanil

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes from baseline in heart rate and mean arterial pressure after intubationintubation periodHeart 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026