Lung Volume Reduction SurgeryPhase 4NCT04226625
Effects of Desflurane and Propofol During Lung Volume Reduction Surgery
A Phase 4 study testing Propofol and Desflurane in people with Lung Volume Reduction Surgery, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Volume Reduction Surgery
- What is being tested?
- Propofol and Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2000to 21 Mar 2002
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo lung volume reduction surgery (LVRS)
Who cannot join
- Does not sign a study consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
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
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.
Read the 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.
- Conditions
- Lung Volume Reduction Surgery
- Being tested
- Propofol, Desflurane
- Keywords
- Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
Intravenous administration
DesfluraneDrug
Also called Suprane
Volatile administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Propofol |
| Desflurane | Active comparator | Patients will receive Desflurane as a gas that is administered through an anesthesia machine. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of discontinuation of anesthetic to eye opening
Measured in minutes
Measured: Up to 30 minutes (during procedure)
Time of discontinuation of anesthetic to tidal volume (TV) 300ml
Measured in minutes
Measured: Up to 30 minutes (during procedure)
Time of discontinuation of anesthetic to extubation
Measured in minutes
Measured: Up to 30 minutes (during procedure)
Secondary outcomes (2)
Duration of intensive care unit (ICU) stay
Measured in days
Measured: Up to 1 month from procedure
Duration of hospital stay
Measured in days
Measured: Up to 1 month from procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start31 Jan 2000
- Primary completion21 Mar 2001
- Study completion21 Mar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Volume Reduction SurgeryStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized to receive propofol or desflurane as the maintenance anesthetic.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bessie Kachulis, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226625
- Sponsor's protocol ID
- AAAR3687
- Other IDs
- 9340
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04226625
- Acronym / sponsor ID
- AAAR3687
- Conditions
- Lung Volume Reduction Surgery
- Keywords
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 31 Jan 2000 (actual)
- Primary completion
- 21 Mar 2001 (actual)
- Study completion
- 21 Mar 2002 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomized to receive propofol or desflurane as the maintenance anesthetic.
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: PropofolPatients will receive Propofol as an intravenous (IV) agent, which is administered into a vein through an IV line as a continuous infusion. |
| Desflurane | Active comparator | Drug: DesfluranePatients will receive Desflurane as a gas that is administered through an anesthesia machine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled to undergo lung volume reduction surgery (LVRS)
Key exclusion criteria (1 listed)
- Does not sign a study consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: DiprivanIntravenous administration | Drug | Propofol |
| DesfluraneAlso: SupraneVolatile administration | Drug | Desflurane |
Primary outcome
Time of discontinuation of anesthetic to eye opening
Time frame: Up to 30 minutes (during procedure)
Measured in minutes
Time of discontinuation of anesthetic to tidal volume (TV) 300ml
Time frame: Up to 30 minutes (during procedure)
Measured in minutes
Time of discontinuation of anesthetic to extubation
Time frame: Up to 30 minutes (during procedure)
Measured in minutes
2 secondary outcomes
Duration of intensive care unit (ICU) stay
Time frame: Up to 1 month from procedure
Duration of hospital stay
Time frame: Up to 1 month from procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bessie Kachulis, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Desflurane in people with Lung Volume Reduction Surgery, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of discontinuation of anesthetic to eye opening (time frame: Up to 30 minutes (during procedure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.