UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014565
Receipt number 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 17:07:01

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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 or person

Institute

Department of Anesthesiology, Tokyo Dental College Ichikawa General Hospital

Institute

Department

Personal name



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

Value
https://center6.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