UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009221
Receipt number R000010823
Scientific Title Comparison of emergence and recovery time, and evaluation of oxygenation during one-lung ventilation with desflurane and propofol anesthesia in lung resection.
Date of disclosure of the study information 2012/10/30
Last modified on 2023/05/09 18:40:45

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Basic information

Public title

Comparison of emergence and recovery time, and evaluation of oxygenation during one-lung ventilation with desflurane and propofol anesthesia in lung resection.

Acronym

Comparison of emergence and recovery time, and evaluation of oxygenation during one-lung ventilation with desflurane and propofol anesthesia in lung resection.

Scientific Title

Comparison of emergence and recovery time, and evaluation of oxygenation during one-lung ventilation with desflurane and propofol anesthesia in lung resection.

Scientific Title:Acronym

Comparison of emergence and recovery time, and evaluation of oxygenation during one-lung ventilation with desflurane and propofol anesthesia in lung resection.

Region

Japan


Condition

Condition

lung cancer

Classification by specialty

Chest surgery Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Which is more adequate general anesthetic agents, desflurane or prropofol , for emergence and recovery time, and perioperative oxygenation in lung resection ?

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

- Blood samples will be collected Immediately after the induction of anesthesia in bilateral lung ventilation, 30 minutes after the start of OLV, one hour after the start of OLV and at the end of surgery in bilateral lung ventilation. Calculates the P / F ratio from the blood gas value.
Evaluation Criteria for Emergence:
-The time from the discontinuation of anesthesia to eye opening
-The time from the discontinuation of anesthesia to extubation.

Key secondary outcomes

-To confirm the effect of HPV by measuring changes in pulmonary blood flow. And also investigate the correlation between the attenuation of pulmonary blood flow and blood oxygen concentration.
- The time from the discontinuation of anesthesia to able to hold hand
- The time from the discontinuation of anesthesia to orientation(state place, state name, state the date of birth)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants 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

A group which are used desflrane as general anesthetics.

Interventions/Control_2

A group which are used propofol as general anesthetics.

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 agree to participate in the study
-Patients undergoing lung cancer surgery requiring OLV.
-ASA 1-2

Key exclusion criteria

Patients with any of the following will be excluded from lung cancer patients.
-NYHA Classification more than II
-Respiratory dysfunction VC or FEV1 is less than 50%
-Pulmonary hypertension with mean pulmonary arterial pressure more than 30mmHg
-Coagulation dysfunction
-The administration of steroids and immunosuppressive agents within 3 months prior to surgery
-Infection with active inflammation
-Pneumonectomy patients
-Cases of epidural anesthesia is contraindicated

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Izumi
Middle name
Last name Kawagoe

Organization

Juntendo University

Division name

Dept. of Anesthesiology and Pain Medicine

Zip code

1138431

Address

1-3, Hongo 3 cho-me, Bunkyo-ku,

TEL

03-3813-3111

Email

ikawago@juntendo.ac.jp


Public contact

Name of contact person

1st name Izumi
Middle name
Last name Kawagoe

Organization

Juntendo University

Division name

Dept. of Anesthesiology and Pain Medicine

Zip code

1138431

Address

1-3, Hongo 3 cho-me, Bunkyo-ku,

TEL

03-3813-3111

Homepage URL


Email

ikawago@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University, Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

IRB of Juntendo University hospital

Address

Hongo3-1-3. Bunkyo-ku, Tokyo

Tel

0358021584

Email

chiken@juntendo.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 10 Month 30 Day


Related information

URL releasing protocol

none

Publication of results

Published


Result

URL related to results and publications

https://tcr.amegroups.com/article/view/62230/html

Number of participants that the trial has enrolled

160

Results

There was no significant difference between the groups in the time to awakening, extubation, or orientation. However, emergence agitation (EA) occurred more frequently in Group D than in Group P. Numbers of patients not achieving full scores in respiration and circulation components of the modified Aldrete score 5 min after extubation were more in Group D. More patients required antiemetics during postoperative 24 hours in Group D.

Results date posted

2023 Year 05 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Included were the American Society of Anesthesiologists (ASA) physical status1 and patients aged between 20 and 75 years, who were scheduled for lung cancer surgery less extensive than pneumonectomy. Excluded were patients with any of the following disorders; severe cardiac disease corresponding to the New York Heart Association Classification more than 2, severe respiratory dysfunction defined as the percent predicted vital capacity or percent predicted forced expiratory volume in one second less than 50 %, pulmonary hypertension with mean pulmonary arterial pressure more than 30 mmHg, active inflammation, a history of treatment with steroids or immunosuppressive agents within 3 months before surgery, severe cognitive impairment, interstitial pneumonia or any contraindication for epidural anesthesia. These exclusion criteria were based on the following assumptions, severe cardiac dysfunction, and severe pulmonary hypertension might affect propofol elimination through possible hepatic congestion, severe respiratory dysfunction might affect the elimination of desflurane via the lungs, and uses of steroids and /or immunosuppressive agents might affect postoperative courses such as developments of postoperative nausea and vomiting (PONV) and postoperative infection.

Participant flow

Eighty patients scheduled for lung cancer surgery between December 2013 and March 2014 in Juntendo University Hospital were enrolled. This was a parallel study, and the allocation ratio was 1:1. Patients were divided into the desflurane group (Group D, n=40) and the propofol group (Group P, n=40) in a randomized manner using the envelope method. The patients did not know the allocated group. After the participants gave written informed consent on the day before surgery, they were randomized into each group using the envelope method, in the registration sequence. Forty pairs of cards, indicating either "propofol" or "desflurane" and put in 40 pairs of envelopes sealed subsequently, had been prepared and shuffled by one anesthesiologist in advance immediately after approval by the IRB.

Adverse events

None

Outcome measures

There was no significant difference between the groups in the time to awakening, extubation, or orientation. However, emergence agitation (EA) occurred more frequently in Group D than in Group P (20/40 vs. 4/40, P<0.001). Numbers of patients not achieving full scores in respiration and circulation components of the modified Aldrete score 5 min after extubation were more in Group D (4/40 vs. 0/40, P=0.040; and 8/40 vs. 2/40, P=0.043, respectively). More patients required antiemetics during postoperative 24 hours in Group D (15/40 vs. 7/40, P=0.045).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 10 Month 16 Day

Date of IRB

2012 Year 09 Month 15 Day

Anticipated trial start date

2012 Year 11 Month 01 Day

Last follow-up date

2019 Year 09 Month 15 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 10 Month 30 Day

Last modified on

2023 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010823


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name