UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011185
Receipt number R000013102
Scientific Title Comparison of intraoperative relatively high-dose and low-dose remifentanil for postoperative epidural analgesia after gynecological abdomonal surgery
Date of disclosure of the study information 2013/07/13
Last modified on 2013/08/25 09:15:21

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Basic information

Public title

Comparison of intraoperative relatively high-dose and low-dose remifentanil for postoperative epidural analgesia after gynecological abdomonal surgery

Acronym

Intraoperative remifentanil for postoperative epidural analgesia

Scientific Title

Comparison of intraoperative relatively high-dose and low-dose remifentanil for postoperative epidural analgesia after gynecological abdomonal surgery

Scientific Title:Acronym

Intraoperative remifentanil for postoperative epidural analgesia

Region

Japan


Condition

Condition

gynecological abdominal surgery

Classification by specialty

Obstetrics and Gynecology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective was to compare the effect of intraoperative high-dose and low-dose remifentanil infusion on postoperative epidural analgesia started at the end of surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

cumulative amount of local anesthetics at 48 h after surgery

Key secondary outcomes

pain intensity assessed with the Prince Henry pain scale


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

In the high-dose remifentanil group, while an end-tidal sevoflurane concentration was maintained at 1.2% throughout anaesthesia, a remifentanil infusion was started at a rate of 0.25 ug/kg/min and subsequently increased or decreased stepwise by 0.05 ug/kg/min increments to maintain systolic blood pressure within 20% of baseline values during surgery.

Interventions/Control_2

In the low-dose remifentanil group, while a remifentanil infusion was maintained at a rate of 0.1 ug/kg/min throughout anaesthesia, an end-tidal sevoflurane concentration was started at 2.0% and subsequently increased or decreased stepwise by 0.5% increments to maintain systolic blood pressure within 20% of baseline values during surgery.

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

69 years-old >=

Gender

Female

Key inclusion criteria

patients undergo elective gynaecological abdominal surgery with lower abdominal incision below umbilicus

Key exclusion criteria

Patients were not excluded if they had diabetes, chronic pain, psychiatric illness, a preoperative use of opioid analgesics, a history of drugs or alcohol abuse, or were unable to use a patient-controlled analgesia (PCA) device. Patients were also excluded if there were any contraindications to epidural catheter placement, or if they refused epidural catheter placement.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yamashita, Soichiro

Organization

University of tsukuba

Division name

Department of Anesthesiology, Faculty of Medicine

Zip code


Address

Tennodai 1-1-1, Tsukuba, Ibaraki 305-8575, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yamashita, Soichiro

Organization

University of tsukuba

Division name

Faculty of Medicine

Zip code


Address


TEL


Homepage URL


Email

soichiyamashita@md.tsukuba.ac.jp


Sponsor or person

Institute

Department of anesthesiology, Faculty of medicine, University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

none

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 07 Month 13 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

2009 Year 07 Month 07 Day

Date of IRB


Anticipated trial start date

2009 Year 09 Month 01 Day

Last follow-up date

2011 Year 04 Month 30 Day

Date of closure to data entry

2012 Year 10 Month 30 Day

Date trial data considered complete

2012 Year 10 Month 30 Day

Date analysis concluded

2013 Year 01 Month 30 Day


Other

Other related information



Management information

Registered date

2013 Year 07 Month 12 Day

Last modified on

2013 Year 08 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013102


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name