UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009412
Receipt number R000011058
Scientific Title Comparison of the effects of propofol and desflurane on lung collapse and operative time during VATS lobectomy
Date of disclosure of the study information 2012/11/27
Last modified on 2023/06/09 13:10:27

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Basic information

Public title

Comparison of the effects of propofol and desflurane on lung collapse and operative time during VATS lobectomy

Acronym

Comparison of the effects of propofol and desflurane on lung collapse and operative time during VATS lobectomy

Scientific Title

Comparison of the effects of propofol and desflurane on lung collapse and operative time during VATS lobectomy

Scientific Title:Acronym

Comparison of the effects of propofol and desflurane on lung collapse and operative time during VATS lobectomy

Region

Japan


Condition

Condition

lung cancer

Classification by specialty

Chest surgery Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm the efficacy of desflurane in maintenance of anesthesia of thoracic surgery, compared with propofol

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

lung collapse score
duration of surgery

Key secondary outcomes

postoperative complication
life prognosis


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

To use 4-6 % of desflurane in maintenance of anesthesia of thoracic surgery during VATS lobectomy anesthesia

Interventions/Control_2

To use 2-4 mcg/ml of propofol in maintenance of anesthesia of thoracic surgery during VATS lobectomy anesthesia

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

patients who are indicated to VATS lobectomy, and age 20-65 years, American Society of Anesthesiologists physical status class 1-2, Hugh-Jones class 1-2, and New York Heart Association class 1-2

Key exclusion criteria

history of cardiovascular or cerebrovascular disease and anticoagulant medication, severe chronic obstructive pulmonary disease, defined as %FEV1.0 < 50% of the predicted values; or severe restrictive lung disease, defined as %VC < 50% of the predicted values

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Ryosuke
Middle name
Last name Kawanishi

Organization

Tokushima University

Division name

Department of Anesthesiology

Zip code

7708503

Address

18-15, 3-chome, Kuramoto-cho, Tokushima-shi, Tokushima, Japan

TEL

0886337181

Email

Kawanishi.riyosuke@tokushima-u.ac.jp


Public contact

Name of contact person

1st name Ryosuke
Middle name
Last name Kawanishi

Organization

Tokushima University

Division name

Department of Anesthesiology

Zip code

770-8503

Address

2-50-1 Koramoto, Tokushima city, Tokushima, Japan

TEL

0886337181

Homepage URL


Email

Kawanishi.riyosuke@tokushima-u.ac.jp


Sponsor or person

Institute

Department of Anesthesiology, Tokushima university

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Tokushima University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research Review Board of Tokushima University

Address

2-50-1 Kuramoto, Tokushima city, Tokushikma, Japan

Tel

0886337958

Email

brinshoshienk@tokushima-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2012 Year 11 Month 27 Day


Related information

URL releasing protocol

https://bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-022-01669-7

Publication of results

Published


Result

URL related to results and publications

https://bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-022-01669-7

Number of participants that the trial has enrolled

60

Results

In VATS lobectomy, desflurane was superior to propofol in lung collapse during one-lung ventilation and shortening the operation time.
Postoperative complications were also better with desflurane.
The prognosis of life and recurrence was not worse with desflurane than with propofol.

Results date posted

2021 Year 09 Month 23 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 09 Month 29 Day

Baseline Characteristics

60 patients scheduled to undergo lobectomy by VATS in Tokushima University Hospital from January 2013 to July 2014

Participant flow

Lungs were inspected by thoracoscope at 10, 30, and 60 min after initiation of OLV. After surgery, the Lung Collapse Score, a composite of lung color and volume assessments, was assigned by two clinicians blinded to the anesthetic regimen. The primary outcome was operation time. The secondary outcome included the complication rate.

Adverse events

none

Outcome measures

Lung collapse score, The primary outcome was operation time. The secondary outcome included the complication rate.

Plan to share IPD

None at present

IPD sharing Plan description

None at present


Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 10 Month 30 Day

Date of IRB

2012 Year 12 Month 21 Day

Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2022 Year 08 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 11 Month 27 Day

Last modified on

2023 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011058


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name