UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002758 |
|---|---|
| Receipt number | R000003353 |
| Scientific Title | Educational efficacy of computer software, showing the effect-site concentration of fentanyl, in anesthesia training |
| Date of disclosure of the study information | 2009/11/16 |
| Last modified on | 2009/11/12 17:01:05 |
* 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
Educational efficacy of computer software, showing the effect-site concentration of fentanyl, in anesthesia training
Acronym
Educational efficacy of computer software, showing the effect-site concentration of fentanyl, in anesthesia
Scientific Title
Educational efficacy of computer software, showing the effect-site concentration of fentanyl, in anesthesia training
Scientific Title:Acronym
Educational efficacy of computer software, showing the effect-site concentration of fentanyl, in anesthesia
Region
| Japan |
Condition
Condition
oral, otolaryngological, maxillofacial, orthopaedi, dermatological, breast, gastroenterological and gynecological
Classification by specialty
| Gastrointestinal surgery | Breast surgery | Obstetrics and Gynecology |
| Dermatology | Oto-rhino-laryngology | Orthopedics |
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intraoperative intravenous fentanyl analgesia is the most widely used and effective. However, activation of opiate receptors leads to significant depression of respiratory frequency. We evaluated that educational efficacy of computer software, showing the effect-site concentration of fentanyl, in anesthesia training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the fentanyl Ce at the end of surgery, intraoperative total doses of fentanyl and propofol, the time required from the end of operation to extubation, and frequency of analgesics required within 24 hours
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Anesthesia management is perfomed with a pharmacokinetic simulation program by anesthesia residents who have experience in using it for within 3 months (P(+) group).
Interventions/Control_2
Anesthesia management is perfomed without a pharmacokinetic simulation program by anesthesia residents who have experience in using it for within three months (P(-) group).
Interventions/Control_3
Anesthesia management is perfomed without a pharmacokinetic simulation program by anesthesia residents who have no experience in using it, under supervision of experienced anesthesiologists (C 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
| 19 | years-old | < |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
American Society of Anethesiologists physical status were 1 or 2.
Key exclusion criteria
patients who use with epidural anesthesia,spinal anesthesia, local anesthesia ,and added to sevoflurane.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuka Matsuki |
Organization
University of Fukui
Division name
Depertment of Molecular Physiology and Biophysics
Zip code
Address
23-3 Matsuokashimoaizuki, Eihiji-cho, Yoshida-gun, Fukui, Japan
TEL
0776-61-8308
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Fukui
Division name
Depertment of Anesthesiology and Reanimatology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
No source of funding
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
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
| 2009 | Year | 11 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2007 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | 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
| 2009 | Year | 11 | Month | 12 | Day |
Last modified on
| 2009 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003353
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
