The EC50 of Remifentanil Blunting Hemodynamic Response to Double Lumen Tube Intubation
This study is currently recruiting participants.
Verified December 2011 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Information provided by (Responsible Party):
Jae-Hyon Bahk, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01542099
First received: February 9, 2012
Last updated: February 24, 2012
Last verified: December 2011
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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 |
| Estimated 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
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, 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: | February 24, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Remifentanil Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 23, 2013