UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002315
Receipt No. 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

* 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 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
Institute Osaka City University Graduate School of Medicine
Institute
Department

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
URL(English) https://upload.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


Contact us.