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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028961
Receipt No. R000033131
Scientific Title Suitability of propofol-remifentanil pharmacodynamic interaction model
Date of disclosure of the study information 2017/10/01
Last modified on 2018/03/07

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Basic information
Public title Suitability of propofol-remifentanil pharmacodynamic interaction model
Acronym Suitability of propofol-remifentanil pharmacodynamic interaction model
Scientific Title Suitability of propofol-remifentanil pharmacodynamic interaction model
Scientific Title:Acronym Suitability of propofol-remifentanil pharmacodynamic interaction model
Region
Japan

Condition
Condition gynecological disease
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Suitability of propofol-remifentanil pharmacodynamic interaction model
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The effect site concentrations of propofol and remifentanil(Loss of consiousness, insertion of a laryngoscopy, recovery of consiousness)
Key secondary outcomes Blood pressure, Heart rate, The noxious stimulus response index (Loss of consiousness, insertion of a laryngoscopy, recovery of consiousness)

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 epidural anesthesia
Interventions/Control_2 transversus abdominis plane block
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

Not applicable
Gender Female
Key inclusion criteria laparoscopic gynecorosical surgery under general aneathesia
ASA1-2

Key exclusion criteria height<150cm, weight<40kg, BMI>30, during pregnancy, during lactation, take antipsychotic drug,
severe heart and/or renal failure, vasopressors in the operation, continuous unstable hemodynamic
parameter (sBP>200mmHg, sBP<80mmHg, HR<40bpm)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ami Sugawara
Organization Asahikawa Medical University
Division name Department of Anesthesiology and Critical care
Zip code
Address 2-1-1-1, midorigaokahigashi, asahikawa, Hokkaido
TEL 0166-68-2583
Email asugawara@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ami Sugawara
Organization Asahikawa Medical University
Division name Department of Anesthesiology and Critical care
Zip code
Address 2-1-1-1, midorigaokahigashi, asahikawa, Hokkaido
TEL 0166-68-2583
Homepage URL
Email asugawara@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

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
2017 Year 10 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 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
2017 Year 09 Month 01 Day
Last modified on
2018 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033131

Research Plan
Registered date File name
2018/09/03 3_kainyu_iyakuiryokiki_相互作用2.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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