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

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 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


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

Value
https://center6.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