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Effects of Desflurane and Propofol During Lung Volume Reduction Surgery

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT04226625
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
25.6
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients presenting for lung volume reduction are very high risk patients and it is important they receive the best anesthetic available. This study aims to answer which is the best anesthetic for managing such cases.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients were randomized to receive propofol or desflurane as the maintenance anesthetic.Patients were randomized to receive propofol or desflurane as the maintenance anesthetic.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Comparison of the Anesthetic and Hemodynamic Effects of a Volatile Anesthetic (Desflurane) and an Intravenous Anesthetic (Propofol), During Lung Volume Reduction Surgery
Actual Study Start Date :
Jan 31, 2000
Actual Primary Completion Date :
Mar 21, 2001
Actual Study Completion Date :
Mar 21, 2002

Arms and Interventions

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.

Drug: Propofol
Intravenous administration
Other Names:
  • Diprivan

    		•
    Active Comparator: Desflurane

    Patients will receive Desflurane as a gas that is administered through an anesthesia machine.

    Drug: Desflurane
    Volatile administration
    Other Names:
  • Suprane

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time of discontinuation of anesthetic to eye opening [Up to 30 minutes (during procedure)]

      Measured in minutes

    2. Time of discontinuation of anesthetic to tidal volume (TV) 300ml [Up to 30 minutes (during procedure)]

      Measured in minutes

    3. Time of discontinuation of anesthetic to extubation [Up to 30 minutes (during procedure)]

      Measured in minutes

    Secondary Outcome Measures

    1. Duration of intensive care unit (ICU) stay [Up to 1 month from procedure]

      Measured in days

    2. Duration of hospital stay [Up to 1 month from procedure]

      Measured in days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Scheduled to undergo lung volume reduction surgery (LVRS)
    Exclusion Criteria:
    • Does not sign a study consent form

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University Irving Medical Center New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University

    Investigators

    • Principal Investigator: Bessie Kachulis, MD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Columbia University
    ClinicalTrials.gov Identifier:
    NCT04226625
    Other Study ID Numbers:
    • AAAR3687
    • 9340
    First Posted:
    Jan 13, 2020
    Last Update Posted:
    Jan 13, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Columbia University
    Anesthesia
    Additional relevant MeSH terms:
    Propofol
    Desflurane

    Study Results

    No Results Posted as of Jan 13, 2020