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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043793
Receipt No. R000049404
Scientific Title Randomized controlled trial for postoperative motor and cognitive improvement by maintaining mild hypercapnia during general anesthesia
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/31

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Basic information
Public title Prospective study for postoperative motor and cognitive improvement by maintaining mild hypercapnia during general anesthesia
Acronym Effects of mild hypercapnia on postoperative motor and cognitive function
Scientific Title Randomized controlled trial for postoperative motor and cognitive improvement by maintaining mild hypercapnia during general anesthesia
Scientific Title:Acronym Effects of mild hypercapnia on postoperative motor and cognitive function
Region
Japan

Condition
Condition Patients undergoing open abdominal surgery under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigate that intraoperative mild hypercapnia improves postoperative cognitive and motor function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Grip strength fluctuation rate on the 7th day after surgery (grip strength on the 7th day after surgery / preoperative grip strength)
Key secondary outcomes Grip strength the day after surgery, incidence of delirium, MMSE score 7 days after surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 mild hypercapnia
Interventions/Control_2 normocapnia
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
60 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria open abdominal surgery patient
Key exclusion criteria 1. Laparoscopic surgery patients
2. Patients with pulmonary hypertension
3. Obstructive lung disease
4. Patients with congenital heart disease
5. Patients with high intracranial pressure
6.Patients with other pathological conditions exacerbated by hypercapnia
7.Patients who used benzodiazepines the day before or during surgery
8.Patients diagnosed with cognitive dysfunction before surgery
9.Patients with difficult epidural insertion
10.Patients whose grip strength measurement is difficult due to physical reasons
11.Emergency surgery
12.State with data loss
13.Patients judged by the principal investigator to be inappropriate as subjects
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Kyongsuk
Middle name
Last name Son
Organization Chiba university hospital
Division name Department of anesthesiology
Zip code 2608677
Address 1-8-1inohana, chuuou-ku, chiba-shi
TEL 0432227171
Email kyong0203suk@yahoo.co.jp

Public contact
Name of contact person
1st name Kyongsuk
Middle name
Last name Son
Organization Chiba university hospital
Division name Department of anesthesiology
Zip code 2608677
Address 1-8-1inohana, chuuou-ku, choba-shi
TEL 0432227171
Homepage URL
Email adya5599@chiba-u.jp

Sponsor
Institute Chiba university
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor MinebeaMitsumi Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Graduate School of Medicine, Chiba University
Address 1-8-1inohana, chuuou-ku, chiba-shi
Tel 0432227171
Email igaku-rinri@office.chiba-u.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
2021 Year 04 Month 01 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
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 Enrolling by invitation
Date of protocol fixation
2021 Year 02 Month 02 Day
Date of IRB
2021 Year 02 Month 02 Day
Anticipated trial start date
2021 Year 04 Month 10 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 31 Day
Last modified on
2021 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049404

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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