UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043793 |
|---|---|
| Receipt number | 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 | 2023/01/30 13:01:09 |
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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
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
adya5599@chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 01 | Month | 24 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 31 | Day |
Last modified on
| 2023 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049404
