UMIN-CTR Clinical Trial

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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