UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002315
Receipt number R000002825
Scientific Title Hemodynamic and electroencephalographic effects of remifentanil during induction and tracheal intubation
Date of disclosure of the study information 2009/09/01
Last modified on 2009/08/09 22:53:46

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Basic information

Public title

Hemodynamic and electroencephalographic effects of remifentanil during induction and tracheal intubation

Acronym

Hemodynamic and electroencephalographic effects of remifentanil

Scientific Title

Hemodynamic and electroencephalographic effects of remifentanil during induction and tracheal intubation

Scientific Title:Acronym

Hemodynamic and electroencephalographic effects of remifentanil

Region

Japan


Condition

Condition

Non-specific

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the dose-dependent effects of remifentanil on hemodynamic and electroencephalographic parameters during induction of anesthesia with midazolam

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

blood pressure, heart rate, bispectral index, 95% spectral edge frequency

Key secondary outcomes

electroencephalographic power in delta, theta, alpha and beta band


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

General anesthesia is induced by midazolam (0.2 mg/kg) after starting continuous infusion of remifentanil (0.1 µg/kg/min). Tracheal intubation is performed 5 min after induction and the rate of infusion of remifentanil is decreased to 0.05 microg/kg/min.

Interventions/Control_2

General anesthesia is induced by midazolam (0.2 mg/kg) after starting continuous infusion of remifentanil (0.2 µg/kg/min). Tracheal intubation is performed 5 min after induction and the rate of infusion of remifentanil is decreased to 0.05 microg/kg/min.

Interventions/Control_3

General anesthesia is induced by midazolam (0.2 mg/kg) after starting continuous infusion of remifentanil (0.5 µg/kg/min). Tracheal intubation is performed 5 min after induction and the rate of infusion of remifentanil is decreased to 0.05 microg/kg/min.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients undergoing operations of the body surface or upper and lower extremities.

Key exclusion criteria

Patients with severe liver or renal dysfunction, bronchial asthma, receiving cytochrome P450 inducer or inhibitors, morbid obesity, predicted difficult intubation, seizure, consciousness disturbance, receiving medications affecting electroencephalogram, hypotension, heart failure, coronary artery disease or history of abnormal reactions by midazolam or remifentanil

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yutaka Oda

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan

TEL

81-6-6645-2186

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yutaka Oda

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Departmental Fee

Organization

Division

Category of Funding Organization

Self funding

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

2009 Year 09 Month 01 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

2008 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 11 Month 01 Day

Last follow-up date

2009 Year 04 Month 01 Day

Date of closure to data entry

2009 Year 05 Month 01 Day

Date trial data considered complete

2009 Year 08 Month 01 Day

Date analysis concluded

2009 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 08 Month 09 Day

Last modified on

2009 Year 08 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002825


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name