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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011295
Receipt No. R000013234
Scientific Title Analysis of the interaction between Remifentanyl and Desflurane, Comparison of autonomic nervous responses, heart rate variability and entropy, to nociceptive stimuli.
Date of disclosure of the study information 2013/08/01
Last modified on 2013/07/27

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Basic information
Public title Analysis of the interaction between Remifentanyl and Desflurane, Comparison of autonomic nervous responses, heart rate variability and entropy, to nociceptive stimuli.
Acronym Analysis of the interaction between Remifentanyl and Desflurane.
Scientific Title Analysis of the interaction between Remifentanyl and Desflurane, Comparison of autonomic nervous responses, heart rate variability and entropy, to nociceptive stimuli.
Scientific Title:Acronym Analysis of the interaction between Remifentanyl and Desflurane.
Region
Japan

Condition
Condition General surgery
Classification by specialty
Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We conducted a study to investigate evaluate MAC-BAR (minimum alveolar concentration, blockade of Autonomic Response) of Desflurane was potentiated by Remifentanyl by using the device for monitoring Heart Rate Variability and Entropy.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Decrement MAC BAR of Desflurane by Remifentanyl.
Key secondary outcomes Limited role of Desflurane inhalation on Decrement MAC BAR.

Base
Study type

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 injection dose of remifentanyl
Interventions/Control_2 inhalation dose of desflurane
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
75 years-old >=
Gender Male and Female
Key inclusion criteria ASA physical status I-II,
aged 20&#8211;70years,
scheduled for elective Laparoscopic Gallbladder surgery (Cholecystectomy)
expected to last at least 5 h

were enrolled in this prospective,
single-blinded, randomized trial.
Key exclusion criteria Patients with a history
of arhythmia, chronic use of psychoactivemedication or illicit drugs, and any clinical significant
cardiovascular, renal, hepatic, or endocrinologic disorders
were excluded.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayano Ooiwa
Organization Toho University School of Medicine
Division name Depertment of Anesthesiology
Zip code
Address 6-11-1 Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
TEL 03-3762-4151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ayano Ooiwa
Organization Toho University School of Medicine
Division name Depertment of Anesthesiology
Zip code
Address 6-11-1 Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
TEL 03-3762-4151
Homepage URL
Email Ayano-nakao@leaf.ocn.ne.jp

Sponsor
Institute Toho University School of Medicine
Institute
Department

Funding Source
Organization Toho University School of Medicine
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 東邦大学医療センター大森病院

Other administrative information
Date of disclosure of the study information
2013 Year 08 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 Enrolling by invitation
Date of protocol fixation
2013 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
2015 Year 10 Month 01 Day
Date trial data considered complete
2016 Year 04 Month 01 Day
Date analysis concluded
2016 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 27 Day
Last modified on
2013 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013234

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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