UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010190
Receipt number R000011932
Scientific Title Randomized controlled trial to measure the Cp50incision of fentanyl with and without flurbiprofen axetil under propofol anesthesia
Date of disclosure of the study information 2013/03/07
Last modified on 2013/03/07 20:25:15

* 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

Randomized controlled trial to measure the Cp50incision of fentanyl with and without flurbiprofen axetil under propofol anesthesia

Acronym

Randomized controlled trial to measure the Cp50incision of fentanyl with and without flurbiprofen axetil under propofol anesthesia

Scientific Title

Randomized controlled trial to measure the Cp50incision of fentanyl with and without flurbiprofen axetil under propofol anesthesia

Scientific Title:Acronym

Randomized controlled trial to measure the Cp50incision of fentanyl with and without flurbiprofen axetil under propofol anesthesia

Region

Japan


Condition

Condition

gynecologic laparoscopy

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We hypothesized that flurbiprofen axetil decreases the plasma fentanyl concentration required to immobilize 50% of patients during skin incision (Cp50incision) when compared with placebo under a target-controlled infusion (TCI) of propofol. We evaluated whether this finding had any significant influence on bispectral index (BIS), blood pressure (BP) and heart rate (HR) between the treatment groups.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

fentanyl Cp50incision,BIS,BLOOD PRESSURE or HEART RATE

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

With flurbiprofen axetil

Interventions/Control_2

Without flurbiprofen axetil

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

55 years-old >=

Gender

Female

Key inclusion criteria

Women (American Society of Anesthesiologists physical status, I&#8211;II; 20&#8211;55 years of age) scheduled to undergo gynecologic laparoscopy were enrolled.

Key exclusion criteria

Patients with hepatic or renal disease, those with a body mass index (BMI) >30 kg.m-2, or those taking long-term analgesics were excluded.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuharu Kodaka

Organization

Tokyo Women's University

Division name

Anesthesiology

Zip code


Address

2-1-10 Nishi-ogu Arakawaku Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Saitama Medical University

Division name

Anesthesiology

Zip code


Address


TEL


Homepage URL

http://www.saitama-med.ac.jp/kawagoe/05others/chiken/LocalSite/smc_iec/070._iec_ver.1.0

Email



Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical 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

2013 Year 03 Month 07 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

2005 Year 11 Month 29 Day

Date of IRB


Anticipated trial start date

2005 Year 11 Month 29 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

2013 Year 03 Month 07 Day

Last modified on

2013 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011932


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name