UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009221
Receipt No. 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 2020/11/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Juntendo University, Faculty of Medicine
Institute
Department

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 160
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
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
2020 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.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


Contact us.