UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045610 |
|---|---|
| Receipt number | R000052074 |
| Scientific Title | RCT on the effects of intraoperative amino acid infusion on the sympathetic nervous system in general anesthesia patients not receiving narcotic analgesics |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/11/01 10:49:00 |
* 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
RCT on the effects of intraoperative amino acid infusion on the sympathetic nervous system in general anesthesia patients not receiving narcotic analgesics
Acronym
RCT on the effects of intraoperative amino acid infusion on the sympathetic nervous system in general anesthesia patients not receiving narcotic analgesics
Scientific Title
RCT on the effects of intraoperative amino acid infusion on the sympathetic nervous system in general anesthesia patients not receiving narcotic analgesics
Scientific Title:Acronym
RCT on the effects of intraoperative amino acid infusion on the sympathetic nervous system in general anesthesia patients not receiving narcotic analgesics
Region
| Japan |
Condition
Condition
Under general anesthesia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effects of amino acid infusion on the sympathetic nervous system
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in pupillary findings during amino acid infusion
Key secondary outcomes
Changes in blood pressure, heart rate, and respiratory rate during amino acid infusion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rapid administration of comprehensive amino acid infusion
Interventions/Control_2
Rapid administration of saline
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing surgery under general anesthesia of ASA-PS I-III
Key exclusion criteria
Contraindications to amino acid infusion, history of sympathetic nervous system disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | shinji |
| Middle name | |
| Last name | takahashi |
Organization
Juntendo University Urayasu Hospital
Division name
Anesthesiology
Zip code
279-0021
Address
2-1-1 Tomioka, Urayasu City, Chiba Prefecture
TEL
047-353-3111
hiramot@gmail.com
Public contact
Name of contact person
| 1st name | YOSHIYUKI |
| Middle name | |
| Last name | HIRAMOTO |
Organization
Juntendo University Urayasu Hospital
Division name
Anesthesiology
Zip code
279-0021
Address
2-1-1 Tomioka, Urayasu City, Chiba Prefecture
TEL
047-353-3111
Homepage URL
hiramot@gmail.com
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431
Tel
03-3814-5672
jcrtc_operation@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
| 2021 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | 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 | 09 | Month | 30 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052074
