- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04226625
Effects of Desflurane and Propofol During Lung Volume Reduction Surgery
A Comparison of the Anesthetic and Hemodynamic Effects of a Volatile Anesthetic (Desflurane) and an Intravenous Anesthetic (Propofol), During Lung Volume Reduction Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The anesthetic technique for lung volume reduction surgery consists of a thoracic epidural in combination with a general anesthetic. The thoracic epidural is routine for this operation and allows administration of local anesthetics and painkillers in the epidural space which results in profound pain relief in the area of surgery. The epidural is routinely used for pain control during the surgery and after the surgery when the patient is awake.
The general anesthetic used may be a volatile agent (gas for example Desflurane), which is administered through the anesthesia machine, or an intravenous anesthetic agent, which is administered into a vein through an intravenous line as a continuous infusion (example Propofol). The use of an anesthetic agent and an epidural often causes a decrease in blood pressure which is treated with medication. The investigators are comparing the two anesthetic techniques regarding their effect on blood pressure and the amount of medication needed to treat it.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10032
- Columbia University Irving Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Scheduled to undergo lung volume reduction surgery (LVRS)
Exclusion Criteria:
- Does not sign a study consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Propofol
Patients will receive Propofol as an intravenous (IV) agent, which is administered into a vein through an IV line as a continuous infusion.
|
Intravenous administration
Other Names:
|
Active Comparator: Desflurane
Patients will receive Desflurane as a gas that is administered through an anesthesia machine.
|
Volatile administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time of discontinuation of anesthetic to eye opening
Time Frame: Up to 30 minutes (during procedure)
|
Measured in minutes
|
Up to 30 minutes (during procedure)
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Time of discontinuation of anesthetic to tidal volume (TV) 300ml
Time Frame: Up to 30 minutes (during procedure)
|
Measured in minutes
|
Up to 30 minutes (during procedure)
|
Time of discontinuation of anesthetic to extubation
Time Frame: Up to 30 minutes (during procedure)
|
Measured in minutes
|
Up to 30 minutes (during procedure)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of intensive care unit (ICU) stay
Time Frame: Up to 1 month from procedure
|
Measured in days
|
Up to 1 month from procedure
|
Duration of hospital stay
Time Frame: Up to 1 month from procedure
|
Measured in days
|
Up to 1 month from procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bessie Kachulis, MD, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- AAAR3687
- 9340 (Other Identifier: CPMC IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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