UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028961 |
|---|---|
| Receipt number | R000033131 |
| Scientific Title | Suitability of propofol-remifentanil pharmacodynamic interaction model |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2020/03/27 13:39:42 |
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Basic information
Public title
Suitability of propofol-remifentanil pharmacodynamic interaction model
Acronym
Suitability of propofol-remifentanil pharmacodynamic interaction model
Scientific Title
Suitability of propofol-remifentanil pharmacodynamic interaction model
Scientific Title:Acronym
Suitability of propofol-remifentanil pharmacodynamic interaction model
Region
| Japan |
Condition
Condition
gynecological disease
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Suitability of propofol-remifentanil pharmacodynamic interaction model
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect site concentrations of propofol and remifentanil(Loss of consiousness, insertion of a laryngoscopy, recovery of consiousness)
Key secondary outcomes
Blood pressure, Heart rate, The noxious stimulus response index (Loss of consiousness, insertion of a laryngoscopy, recovery of consiousness)
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
epidural anesthesia
Interventions/Control_2
transversus abdominis plane block
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
| Not applicable |
Gender
Female
Key inclusion criteria
laparoscopic gynecorosical surgery under general aneathesia
ASA1-2
Key exclusion criteria
height<150cm, weight<40kg, BMI>30, during pregnancy, during lactation, take antipsychotic drug,
severe heart and/or renal failure, vasopressors in the operation, continuous unstable hemodynamic
parameter (sBP>200mmHg, sBP<80mmHg, HR<40bpm)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ami Sugawara |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical care
Zip code
Address
2-1-1-1, midorigaokahigashi, asahikawa, Hokkaido
TEL
0166-68-2583
asugawara@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ami Sugawara |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical care
Zip code
Address
2-1-1-1, midorigaokahigashi, asahikawa, Hokkaido
TEL
0166-68-2583
Homepage URL
asugawara@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
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
Other administrative information
Date of disclosure of the study information
| 2017 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 01 | Day |
Last modified on
| 2020 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033131
