NCT04226625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2000

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2000

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2001

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2002

Completed
17.8 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

January 8, 2020

Last Update Submit

January 9, 2020

Conditions

Lung Volume Reduction Surgery

Keywords

Anesthesia

Outcome Measures

Primary Outcomes (3)

  • Time of discontinuation of anesthetic to eye opening

    Measured in minutes

    Up to 30 minutes (during procedure)

  • Time of discontinuation of anesthetic to tidal volume (TV) 300ml

    Measured in minutes

    Up to 30 minutes (during procedure)

  • Time of discontinuation of anesthetic to extubation

    Measured in minutes

    Up to 30 minutes (during procedure)

Secondary Outcomes (2)

  • Duration of intensive care unit (ICU) stay

    Up to 1 month from procedure

  • Duration of hospital stay

    Up to 1 month from procedure

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Desflurane

ACTIVE COMPARATOR

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

Drug: Desflurane

Interventions

PropofolDRUG

Intravenous administration

Also known as: Diprivan
Propofol
DesfluraneDRUG

Volatile administration

Also known as: Suprane
Desflurane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled to undergo lung volume reduction surgery (LVRS)

You may not qualify if:

  • Does not sign a study consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

PropofolDesflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsEthyl EthersEthersMethyl EthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Bessie Kachulis, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Patients were randomized to receive propofol or desflurane as the maintenance anesthetic.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

January 31, 2000

Primary Completion

March 21, 2001

Study Completion

March 21, 2002

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)