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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004168
Receipt No. 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

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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
Obsterics 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
Email

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
Email ejmasaki@m.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005003

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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