UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021210 |
|---|---|
| Receipt number | R000024451 |
| Scientific Title | The evaluation study of an autonomic nerve activity in rising motion of a postoperative patient's body who underwent general anesthesia. |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2017/02/27 04:27:24 |
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Basic information
Public title
The evaluation study of an autonomic nerve activity in rising motion of a postoperative patient's body who underwent general anesthesia.
Acronym
The evaluation study of an autonomic nerve activity in rising motion of a postoperative patient's body who underwent general anesthesia.
Scientific Title
The evaluation study of an autonomic nerve activity in rising motion of a postoperative patient's body who underwent general anesthesia.
Scientific Title:Acronym
The evaluation study of an autonomic nerve activity in rising motion of a postoperative patient's body who underwent general anesthesia.
Region
| Japan |
Condition
Condition
parotid gland tumor
Classification by specialty
| Oto-rhino-laryngology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate an autonomic nerve activity and hemodynamics in rising motion of a postoperative patient's body who underwent general anesthesia.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of change in the cardiac output,
low frequency and high frequency before and after anesthesiology
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)patients underwent general anesthesia and elective operation in otorhinolaryngology.
(2)patients who can judge by myself about participation for study.
Key exclusion criteria
(1)patients who are diagnosed with ischemic heart disease,heart failure, hypertension and autonomic ataxia.
(2)patients who take sympathomimetic drug,sympatholytic drug,hypotensive agent and anticholinergic drug.
(3)patients who implanted pacemaker.
(4)patients who cannot become independent in ADL.
(5)patients who are observed atrial fibrillation and extrasystole.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Hosogaya |
Organization
Nippon Medical School Hospital
Division name
Nursing department
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL
03-3822-2131
gaya-j@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Research Promotion Division |
Organization
Nippon Medical School
Division name
secretariat of Nippon Medical School
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
TEL
03-3822-2131
Homepage URL
kaken@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design;case series
Subjects; Patients with otolaryngology who undergone general anesthesia at Nippon Medical School Hospital from May 2017 to September 2017.
Observation data includes patients' background, BMI,Cardiac output and Heart rate variability.
Management information
Registered date
| 2016 | Year | 02 | Month | 25 | Day |
Last modified on
| 2017 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024451
