UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027359 |
|---|---|
| Receipt number | R000030485 |
| Scientific Title | Prediction of hazardous fluctuations in blood pressure at induction of general anesthesia by propofol in non-cardiac surgery |
| Date of disclosure of the study information | 2017/05/16 |
| Last modified on | 2018/12/07 13:21:19 |
* 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
Prediction of hazardous fluctuations in blood pressure at induction of general anesthesia by propofol in non-cardiac surgery
Acronym
Establishment of the prediction formula of propofol during anesthesia induction in non-cardiac surgery
Scientific Title
Prediction of hazardous fluctuations in blood pressure at induction of general anesthesia by propofol in non-cardiac surgery
Scientific Title:Acronym
Establishment of the prediction formula of propofol during anesthesia induction in non-cardiac surgery
Region
| Japan |
Condition
Condition
Patients underwent surgey under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the prediction formula to prevent hazardous fluctuations in blood pressure at induction of general anesthesia by propofol in non-cardiac surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fluctuations in blood pressure between before and after induction of general anesthesia
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
18 and older
general anesthesia induction using propofol
non-cardiac surgery
Key exclusion criteria
emergency surgery
organ transplantation
rapid sequence or slow induction
intubation through a tracheotomy or nasal passage
multiple direct laryngoscopy
extra drug administration
insufficient description
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sumio Hoka |
Organization
Kyushu University
Division name
Department of anesthesiology and critical care medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
092-642-5714
shoka@kuaccm.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sho Kawasaki |
Organization
Kyushu University
Division name
Department of anesthesiology and critical care medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
092-642-5714
Homepage URL
sho0806@kuaccm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Department of anesthesiology and critical care medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | 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
finished
Management information
Registered date
| 2017 | Year | 05 | Month | 16 | Day |
Last modified on
| 2018 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030485
