UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004168 |
|---|---|
| Receipt number | R000005003 |
| Scientific Title | Perioperative infusion of dexmedetomidine at a high dose reduced postoperative analgesic requirements |
| Date of disclosure of the study information | 2010/09/07 |
| Last modified on | 2010/09/15 14:46:21 |
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Basic information
Public title
Perioperative infusion of dexmedetomidine at a high dose reduced postoperative analgesic requirements
Acronym
Analgesic effects of dexmedetomidine on postoperative pain status
Scientific Title
Perioperative infusion of dexmedetomidine at a high dose reduced postoperative analgesic requirements
Scientific Title:Acronym
Analgesic effects of dexmedetomidine on postoperative pain status
Region
| Japan |
Condition
Condition
Patient undergoing radical surgery for malignant gynecological disease
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of postoperative analgesic effects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Requirements of analgesics
Key secondary outcomes
Hemodynamic changes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dexmedetomidine is administered at 1mcg/kg/hr in 16 patients undergoing open abdominal surgery for malignant gynecological diseases and postoperative pain status is evaluated.
Interventions/Control_2
Volume-matched normal saline is administered in 16 patients undergoing open abdominal surgery for malignant gynecological diseases and postoperative pain status is evaluated.
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
Patients with indication of radical surgery for malignant gynecological disease.
Key exclusion criteria
Patients with known hypersensitivity of ropivacaine, history of mental illness, use of psychotopic medicine, pain medication prior to surgery, history of impaired sensation.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Masaki |
Organization
Tohoku University Hospital
Division name
Anesthesiology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8401
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Masaki |
Organization
Tohoku University Hospital
Division name
Anesthesiology
Zip code
Address
TEL
Homepage URL
ejmasaki@m.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 09 | Month | 07 | 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
Completed
Date of protocol fixation
| 2008 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | 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
| 2010 | Year | 09 | Month | 07 | Day |
Last modified on
| 2010 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005003
