UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042785 |
|---|---|
| Receipt number | R000048836 |
| Scientific Title | Influence of opiod on effect of propofol |
| Date of disclosure of the study information | 2020/12/20 |
| Last modified on | 2021/12/28 11:56:00 |
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Basic information
Public title
Influence of opioid on the relationship between effect-site concentration of propofol at loss of response and that at maintenance of anesthesia
Acronym
Influence of opioid on the relationship between effect-site concentration of propofol at loss of response and that at maintenance of anesthesia
Scientific Title
Influence of opiod on effect of propofol
Scientific Title:Acronym
Influence of opiod on effect of propofol
Region
| Japan |
Condition
Condition
breast tumor and gall stone
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We previously showed that effect-site concentration of propofol at loss of response to verbal command (Ce-LOR) and that when EEG alpha power became maximum (Ce-alpha) were closely correlated. On the other hand, use of opioid such as fentanyl or remifentanil made Ce-LOR lower. Then we tried to clarify the effect of remifentanil on the relationship between Ce-LOR and Ce-alpha of propofol. Furthermore, we also tried to clarify the relationship between Ce-OBS (Ce at the onset of burst suppression) and them.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We investigate the relationship between Ce-LOR, Ce-alpha and Ce-OBS when effect-site concentration of remifentanil was kept 0, 0.1 or 0.2 ng/mL.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
No remifentanil is used.
Interventions/Control_2
Ce of remifentanil was controlled at 1.0 ng/mL.
Interventions/Control_3
Ce of remifentanil was controlled at 2.0 ng/mL.
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
Male and Female
Key inclusion criteria
Patinets who satisfied the following all conditions.
1) Age is 20 or more.
2) Hospitalized patient
3) both gender
4) ASA-PS is I or II
5) Low surgical stress
6) patients who scheduled lapaloscopic cholecystectcomy or mannmectomy
7) patients who agreed after informed consent
Key exclusion criteria
patients who matched either of following conditions.
1) patients who had severe liver dysfunction or severe renal dysfunction
2) pregnant or lactating women
3) patients who are medicated a drug that had interaction with propofol
4) patients who had neurological disorder
5) patients who showed allergy to propofol
6) ASA-PS III or more
7) obesity (BMI is 35 or more)
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Hagihira |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
573-1191
Address
2-5-1 Shin-machi, Hirakata City
TEL
072-804-2683
hagihirs@hirakata.kmu.a.cjp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Hagihira |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
573-1191
Address
2-5-1 Shin-machi, Hirakata City
TEL
072-804-2683
Homepage URL
hagihirs@hirakata.kmu.a.cjp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Departmential resources
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
Kansai Medical University center for ethical review
Address
2-5-1 Shin-machi, Hirakata City
Tel
072-804-2440
rinriirb@hirakata.kmu.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
| 2020 | Year | 12 | Month | 20 | 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
| 2020 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 12 | Month | 18 | Day |
Last modified on
| 2021 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048836
