UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059116 |
|---|---|
| Receipt number | R000067625 |
| Scientific Title | A interaction of sedative effect between Propofol and Remifentanil |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/18 08:17:17 |
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Basic information
Public title
A Study on the Interaction Between Anesthetic and Analgesic Drugs
Acronym
Anesthetics and Analgesics Interaction Study
Scientific Title
A interaction of sedative effect between Propofol and Remifentanil
Scientific Title:Acronym
A interaction of sedative effect between Propofol and Remifentanil
Region
| Japan |
Condition
Condition
Patients who undergo surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Previous studies have shown that remifentanil affects three effect-site concentrations of propofol, the concentration at loss of responsiveness , the concentration at which the power in the alpha frequency band is maximal, and the concentration at which burst suppression patterns appear on the EEG - during the initiation of total intravenous anesthesia with propofol. In this study, we will investigate whether increasing the concentration of remifentanil further influences these three propofol concentrations.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between propofol concentrations at loss of responsiveness, maximum power in the alpha frequency band, and appearance of burst suppression patterns on EEG at predicted remifentanil effect-site concentrations of 0 ng/ml, 3.0 ng/ml, and 4.0 ng/ml.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Remifentanil 0 ng/mL group
Interventions/Control_2
Remifentanil 3.0 ng/mL group
Interventions/Control_3
Remifentanil 4.0 ng/mL group
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study will include patients undergoing surgery under general anesthesia at Kansai Medical University Hospital. To select surgeries with stable hemodynamics, patients scheduled for breast surgery or laparoscopic cholecystectomy will be included.
Key exclusion criteria
Exclusion criteria included serious liver dysfunction, renal dysfunction, or psychological disorders, pregnancy, lactation or receipt of psychotropic drugs, and allergy to propofol or remifentanil.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Aihara |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
573-1191
Address
2-5-1 Shin-Machi Hirakata Osaka
TEL
0728040101
aihara.sat@kmu.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Aihara |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
573-1191
Address
2-5-1 Shin-Machi Hirakata Osaka
TEL
0728040101
Homepage URL
aihara.sat@kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Satoshi Aihara
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
the Research Ethical Committee of Kansai Medical University
Address
2-5-1 Shin-Machi Hirakata Osaka
Tel
0728042440
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
| 2025 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067625
