Effects of Desflurane and Propofol During Lung Volume Reduction Surgery

January 9, 2020 updated by: Columbia University

A Comparison of the Anesthetic and Hemodynamic Effects of a Volatile Anesthetic (Desflurane) and an Intravenous Anesthetic (Propofol), During Lung Volume Reduction Surgery

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scheduled to undergo lung volume reduction surgery (LVRS)

Exclusion Criteria:

  • Does not sign a study consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Diprivan
Active Comparator: Desflurane
Patients will receive Desflurane as a gas that is administered through an anesthesia machine.
Volatile administration
Other Names:
  • Suprane

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)
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bessie Kachulis, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2000

Primary Completion (Actual)

March 21, 2001

Study Completion (Actual)

March 21, 2002

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 9, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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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