UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002758
Receipt No. 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

* 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 Obsterics 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
Email

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
Email

Sponsor
Institute University of Fukui
Institute
Department

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
Email

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
URL(English) https://upload.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


Contact us.