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
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
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
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
