Lung CancerNCT02324283
Comparison of Emergence and Oxygenation During One-lung Ventilation With Desflurane and Propofol Anesthesia
A study testing desflurane and propofol in people with Lung Cancer, run by Juntendo University at 1 site in Japan.
Trial summary
Which is more adequate general anesthetic agent, desflurane or propofol, for emergence and recovery time, and perioperative oxygenation in lung resection surgery? Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- desflurane and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2012to Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients agree to participate in the study
- Patients undergoing lung cancer surgery requiring one-lung ventilation.
- American Society of Anesthesiologists Physical Status Class 1 or 2
Who cannot join
- Patients with any of the following will be excluded from lung cancer patients.
- New York Heart Association Classification more than 2
- Respiratory dysfunction Vital Capacity or percent predicted Forced expiratory volume in one second is less than 50 %
- Pulmonary hypertension with mean pulmonary arterial pressure more than 30 mmHg
- Coagulation dysfunction
- The administration of steroids and immunosuppressive agents within 3 months prior to surgery
Show all 9Show fewer
- Infection with active inflammation
- Pneumonectomy patients
- Cases of epidural anesthesia is contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Emergence and Recovery Time, and Evaluation of Oxygenation During One-lung Ventilation With Desflurane and Propofol Anesthesia in Lung Surgery- A Pilot Study
Which is more adequate general anesthetic agent, desflurane or propofol, for emergence and recovery time, and perioperative oxygenation in lung resection surgery?
Read the detailed description
The investigators plan to investigate the effects of desflurane on oxygenation (prevention of HPV) of OLV compare with propofol which is used in general anesthesia for lung resection.
Transesophageal echocardiography (TEE) wiill be used to measure pulmonary blood flow during surgery visible and successively. To confirm the effect of HPV by measuring the change in pulmonary blood flow. The correlation between the blood oxygen concentration and attenuation of blood flow will be investigated.
- Conditions
- Lung Cancer
- Being tested
- desflurane, propofol
- Keywords
- one-lung ventilation, oxygenation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desfluraneDrug
Also called Suprene
Desflurane group: this group of patients receives desflurane as the main anesthetic agent during one-lung anesthesia.
Propofol group: this group of patients receives propofol as the main anesthetic agnet during on-lung anesthesia.
propofolDrug
Also called Diprivan
Propofol group:this group of patients receives propofol as the main anesthetic agent during one-lung anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Desflurane | Active comparator | Desflurane group: this group of patients receives desflurane as the main anesthetic agent in addition to remifentanil infusion at 0.1~0.3 mcg/kg/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured. Receives: Drug: desflurane |
| Propofol | Active comparator | Propofol group: this group of patients receives propofol as the main anesthetic agent in addition to remifentanil infusion at the rate of 0.1~0.3 mcg./g/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation
Arterial blood gases are monitored.Pulmonary blood flow is measured using transesophageal echocardiogram.
Measured: prior to surgery to one-hour after extubation
Secondary outcomes (3)
Rapidity of Emergence From Anesthesia
Time to extubation and orientation, where the patient is.
Measured: one minute after cessation of anethetic agents to one hour after extubation
Quality of Consiousness
quality of consciousness will be assessed using Aldrete score
Measured: after extubation
Postoperative Nausea and Vomiting
degree of nausea and frequency of vomiting
Measured: on the postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startOct 2012
- Primary completionJun 2016
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juntendo University
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Eiichi Inada, M.D., Principal investigator, Juntendo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324283
- Sponsor's protocol ID
- 12-97
- Status last verified
- Apr 2024
- First submitted
- 15 Dec 2014
- Last updated
- 5 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Emergence and Recovery Time, and Evaluation of Oxygenation During One-lung Ventilation With Desflurane and Propofol Anesthesia in Lung Surgery- A Pilot Study
- ClinicalTrials.gov ID
- NCT02324283
- Acronym / sponsor ID
- 12-97
- Conditions
- Lung Cancer
- Keywords
- one-lung ventilation, oxygenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Juntendo UniversityUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 5 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Which is more adequate general anesthetic agent, desflurane or propofol, for emergence and recovery time, and perioperative oxygenation in lung resection surgery?
Detailed description
The investigators plan to investigate the effects of desflurane on oxygenation (prevention of HPV) of OLV compare with propofol which is used in general anesthesia for lung resection.
Transesophageal echocardiography (TEE) wiill be used to measure pulmonary blood flow during surgery visible and successively. To confirm the effect of HPV by measuring the change in pulmonary blood flow. The correlation between the blood oxygen concentration and attenuation of blood flow will be investigated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane | Active comparator | Drug: desfluraneDesflurane group: this group of patients receives desflurane as the main anesthetic agent in addition to remifentanil infusion at 0.1~0.3 mcg/kg/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured. |
| Propofol | Active comparator | Drug: propofolPropofol group: this group of patients receives propofol as the main anesthetic agent in addition to remifentanil infusion at the rate of 0.1~0.3 mcg./g/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients agree to participate in the study
- Patients undergoing lung cancer surgery requiring one-lung ventilation.
- American Society of Anesthesiologists Physical Status Class 1 or 2
Key exclusion criteria (9 listed)
- Patients with any of the following will be excluded from lung cancer patients.
- New York Heart Association Classification more than 2
- Respiratory dysfunction Vital Capacity or percent predicted Forced expiratory volume in one second is less than 50 %
- Pulmonary hypertension with mean pulmonary arterial pressure more than 30 mmHg
- Coagulation dysfunction
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 |
|---|---|---|
| desfluraneAlso: SupreneDesflurane group: this group of patients receives desflurane as the main anesthetic agent during one-lung anesthesia. Propofol group: this group of patients receives propofol as the main anesthetic agnet during on-lung anesthesia. | Drug | Desflurane |
| propofolAlso: DiprivanPropofol group:this group of patients receives propofol as the main anesthetic agent during one-lung anesthesia. | Drug | Propofol |
Primary outcome
Oxygenation
Time frame: prior to surgery to one-hour after extubation
Arterial blood gases are monitored.Pulmonary blood flow is measured using transesophageal echocardiogram.
3 secondary outcomes
Rapidity of Emergence From Anesthesia
Time frame: one minute after cessation of anethetic agents to one hour after extubation
Quality of Consiousness
Time frame: after extubation
Postoperative Nausea and Vomiting
Time frame: on the postoperative day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Eiichi Inada, M.D. principal investigator
Juntendo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing desflurane and propofol in people with Lung Cancer, run by Juntendo University at 1 site in Japan.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. 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 Japan. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Oxygenation (time frame: prior to surgery to one-hour after extubation). 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 5 Apr 2024.