UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011295 |
|---|---|
| Receipt number | 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 04:17:23 |
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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 20–70years,
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
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
Ayano-nakao@leaf.ocn.ne.jp
Sponsor or person
Institute
Toho University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
