UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021731
Receipt No. R000023457
Scientific Title Difference of the post operative analgesia effect between single and continuous Fentanyl injection during surgery
Date of disclosure of the study information 2016/04/01
Last modified on 2016/09/16

* 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 Difference of the post operative analgesia effect between single and continuous Fentanyl injection during surgery
Acronym Difference of the post operative analgesia effect between single and continuous Fentanyl injection during surgery
Scientific Title Difference of the post operative analgesia effect between single and continuous Fentanyl injection during surgery
Scientific Title:Acronym Difference of the post operative analgesia effect between single and continuous Fentanyl injection during surgery
Region
Japan

Condition
Condition Total Hip Arthroplasty
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 method of administration of intraoperative fentanyl is continuously administered with a single dose, but ther is the possibility that the difference of the analgesic effect, side effects . Therefore, we will compare the differences between the effects and side effects of taking the two methods of administration.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Analgesic effect, time until awakening, the frequency of use of vasopressors, impact on the respiratory rate and blood pressure and pulse rate, the presence or absence of nausea and vomiting
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 continuous infusion of fentanyl 4mcg/kg during total hip surgery(about 1 hour).
Interventions/Control_2 single shot of fentanyl 4mcg/kg 15 minutes before the end of total hip surgery.
Interventions/Control_3
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
80 years-old >
Gender Female
Key inclusion criteria ASA1-2
Key exclusion criteria fentanyl allergy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiichi Yasuda
Organization NissanTamagawa Hospital
Division name Department of Anesthesia
Zip code
Address 4-8-1 Seta,Setagaya-ku,Tokyo 158-0095 Japan
TEL 03-3700-1151
Email ysd5963@wave.plala.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiichi Yasuda
Organization NissanTamagawa Hospital
Division name Department of Anesthesia
Zip code
Address 4-8-1 Seta,Setagaya-ku,Tokyo 158-0095 Japan
TEL 03-3700-1151
Homepage URL
Email ysd5963@wave.plala.or.jp

Sponsor
Institute NissanTamagawa Hospital Department of Anesthesia
Institute
Department

Funding Source
Organization Nissan Kohseikai Institute of Medicine
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2016 Year 04 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 Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 04 Day
Last follow-up date
2016 Year 09 Month 16 Day
Date of closure to data entry
2016 Year 09 Month 16 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 01 Day
Last modified on
2016 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023457

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.