- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02324283
Comparison of Emergence and Oxygenation During One-lung Ventilation With Desflurane and Propofol Anesthesia
Comparison of Emergence and Recovery Time, and Evaluation of Oxygenation During One-lung Ventilation With Desflurane and Propofol Anesthesia in Lung Surgery- A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators plan to investigate the effects of desflurane on oxygenation (prevention of HPV) of OLV compare with propofol which is used in general anesthesia for lung resection.
Transesophageal echocardiography (TEE) wiill be used to measure pulmonary blood flow during surgery visible and successively. To confirm the effect of HPV by measuring the change in pulmonary blood flow. The correlation between the blood oxygen concentration and attenuation of blood flow will be investigated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tokyko
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Bunkyo-ku, Tokyko, Japan, 113-8421
- University of Juntendo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients agree to participate in the study
- Patients undergoing lung cancer surgery requiring one-lung ventilation.
- American Society of Anesthesiologists Physical Status Class 1 or 2
Exclusion Criteria:
- Patients with any of the following will be excluded from lung cancer patients.
- New York Heart Association Classification more than 2
- Respiratory dysfunction Vital Capacity or percent predicted Forced expiratory volume in one second is less than 50 %
- Pulmonary hypertension with mean pulmonary arterial pressure more than 30 mmHg
- Coagulation dysfunction
- The administration of steroids and immunosuppressive agents within 3 months prior to surgery
- Infection with active inflammation
- Pneumonectomy patients
- Cases of epidural anesthesia is contraindicated
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Desflurane
Desflurane group: this group of patients receives desflurane as the main anesthetic agent in addition to remifentanil infusion at 0.1~0.3
mcg/kg/min during one-lung anesthesia.
Bispectral index will be maintained between 45 and 50.
Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured.
|
Desflurane group: this group of patients receives desflurane as the main anesthetic agent during one-lung anesthesia. Propofol group: this group of patients receives propofol as the main anesthetic agnet during on-lung anesthesia.
Other Names:
|
Active Comparator: Propofol
Propofol group: this group of patients receives propofol as the main anesthetic agent in addition to remifentanil infusion at the rate of 0.1~0.3
mcg./g/min during one-lung anesthesia.
Bispectral index will be maintained between 45 and 50.
Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured.
|
Propofol group:this group of patients receives propofol as the main anesthetic agent during one-lung anesthesia.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygenation
Time Frame: prior to surgery to one-hour after extubation
|
Arterial blood gases are monitored.Pulmonary blood flow is measured using transesophageal echocardiogram.
|
prior to surgery to one-hour after extubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rapidity of Emergence From Anesthesia
Time Frame: one minute after cessation of anethetic agents to one hour after extubation
|
Time to extubation and orientation, where the patient is.
|
one minute after cessation of anethetic agents to one hour after extubation
|
Quality of Consiousness
Time Frame: after extubation
|
quality of consciousness will be assessed using Aldrete score
|
after extubation
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Postoperative Nausea and Vomiting
Time Frame: on the postoperative day 1
|
degree of nausea and frequency of vomiting
|
on the postoperative day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eiichi Inada, M.D., Juntendo University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-97
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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