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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014565
Receipt No. R000016900
Scientific Title Postoperative pain was successfully treated with 8 mcg/kg of transitional fentanyl following high dose remifentanil anesthesia.
Date of disclosure of the study information 2014/09/01
Last modified on 2014/07/15

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Basic information
Public title Postoperative pain was successfully treated with 8 mcg/kg of transitional fentanyl following high dose remifentanil anesthesia.
Acronym Postoperative pain was successfully treated with 8 mcg/kg of transitional fentanyl following high dose remifentanil anesthesia.
Scientific Title Postoperative pain was successfully treated with 8 mcg/kg of transitional fentanyl following high dose remifentanil anesthesia.
Scientific Title:Acronym Postoperative pain was successfully treated with 8 mcg/kg of transitional fentanyl following high dose remifentanil anesthesia.
Region
Japan

Condition
Condition jaw deformity
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present study was performed to investigate whether the administration of 8 mcg/kg transitional fentanyl could reduce postoperative fentanyl consumption following high-dose remifentanil anesthesia.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of fentanyl administered within 24 hours after surgery.
Visual analog scale (VAS) values at 1, 3, 6, and 24 hours after surgery.
Key secondary outcomes Estimated effect-site concentrations of both fentanyl and remifentanil at extubation.
Time from the completion of surgery to the extubation.
Side-effects.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of 1 mcg/kg/min of remifentanil combined with 4 mcg/kg transitional fentanyl.
Interventions/Control_2 Administration of 1 mcg/kg/min of remifentanil combined with 8 mcg/kg transitional fentanyl.
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
16 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria patients who undergoing orthognathic surgery were included in this study.
American Society of Anesthesiologists (ASA) physical status I-II.
Key exclusion criteria they had obesity (body mass index over 30 kg/m2);
could not be extubated immediately after surgery;
had been treated any analgesic drug within 24 hours prior to surgery;
had a history of chronic pain, drug or alcohol abuse, or psychiatric disease;
and had contraindications to the self-administration of opioids [i.e. they were unable to understand the patient-controlled analgesia (PCA) device].
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyotaro Koshika
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Anesthesiology
Zip code
Address 5-11-13 Sugano, Ichikawa-shi, Chiba-ken, Japan
TEL 047-322-0151
Email koshikakyotarou@tdc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyotaro Koshika
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Anesthesiology
Zip code
Address 5-11-13 Sugano, Ichikawa-shi, Chiba-ken, Japan
TEL 047-322-0151
Homepage URL
Email koshikakyotarou@tdc.ac.jp

Sponsor
Institute Department of Anesthesiology, Tokyo Dental College Ichikawa General Hospital
Institute
Department

Funding Source
Organization MSD K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor AstraZeneca K.K.
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 東京歯科大学市川総合病院(千葉県)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 01 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
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
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 15 Day
Last modified on
2014 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016900

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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