UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011754 |
|---|---|
| Receipt number | R000013748 |
| Scientific Title | Influence of pharmacokinetic model of propofol on the predicted plasma concentration |
| Date of disclosure of the study information | 2013/09/13 |
| Last modified on | 2023/03/22 13:27:58 |
* 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
Influence of pharmacokinetic model of propofol on the predicted plasma concentration
Acronym
Influence of pharmacokinetic model of propofol on the predicted plasma concentration
Scientific Title
Influence of pharmacokinetic model of propofol on the predicted plasma concentration
Scientific Title:Acronym
Influence of pharmacokinetic model of propofol on the predicted plasma concentration
Region
| Japan |
Condition
Condition
patients undergoing elective surgery under general anesthesia
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to investigate whether published pharmacokinetic models influence on its prediction of plasma concentrations.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plasma concentration of propofol
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
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
propofol infusion at the maximum rate of 1200 ml/h using the Marsh pharmacokinetic model
Interventions/Control_2
propofol infusion at the maximum rate of 300 ml/h using the Marsh pharmacokinetic model
Interventions/Control_3
propofol infusion at the maximum rate of 100 ml/h using the Marsh pharmacokinetic model
Interventions/Control_4
propofol infusion at the maximum rate of 1200 ml/h using the Schnider pharmacokinetic model
Interventions/Control_5
propofol infusion at the maximum rate of 300 ml/h using the Schnider pharmacokinetic model
Interventions/Control_6
propofol infusion at the maximum rate of 100 ml/h using the Schnider pharmacokinetic model
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
patients undergoing elective surgery under general anesthesia
Key exclusion criteria
significant heart, respiratory, hepatic, or renal imparement cardiovascular disease; recent use of psychoactive medicine; body mass index greater than 30
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Masui |
Organization
National Defense Medical College Hospital
Division name
Department of Anesthesiology
Zip code
359-8513
Address
Namiki 3-2, Tokorozawa, Saitama, Japan
TEL
04-2995-1692
kenichi@masuinet.com
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Masui |
Organization
National Defense Medical College Hospital
Division name
Department of Anesthesiology
Zip code
359-8513
Address
Namiki 3-2, Tokorozawa, Saitama, Japan
TEL
04-2995-1692
Homepage URL
kenichi@masuinet.com
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College
Address
Namiki 3-2, Tokorozawa, Saitama, Japan
Tel
02-2995-1511
honrinri@masuinet.com
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
| 2013 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
| 2009 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2022 | 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
| 2013 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013748
