UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019977 |
|---|---|
| Receipt number | R000023066 |
| Scientific Title | Efficacy and safety of orexin receptor antagonist as premedication |
| Date of disclosure of the study information | 2015/11/30 |
| Last modified on | 2015/12/07 19:15:07 |
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Basic information
Public title
Efficacy and safety of orexin receptor antagonist as premedication
Acronym
Orexin receptor antagonist premedication
Scientific Title
Efficacy and safety of orexin receptor antagonist as premedication
Scientific Title:Acronym
Orexin receptor antagonist premedication
Region
| Japan |
Condition
Condition
Patients who underwent surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Many sleeping pills is adaptive as premedication, have been used.
There is no report of use experience as a premedication of orexin receptor antagonists Belsomra ®.
In this study, it was administered Belsomra ® as a pre-medication, to consider the effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure, Herat rate, Pulse oximetry, Ramsey sedation score:RSS
Key secondary outcomes
visual analog scale
postoperative nause and vomiting
Patient satisfaction
Safety of transport
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patient receive oral belsomra premedication before induction anesthesia.
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients, ASA physical state of I-III, undergoing surgery with general anesthesia
.
Key exclusion criteria
over ASA physical state of IV
pregnancy
patients under twenty year old
Patient consent can not be obtained
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nami Kakuta |
Organization
Institute of Biomedical Sciences Tokushima University Graduate School
Division name
Department of Anesthesiology
Zip code
Address
770-8503
TEL
81-88-633-7181
kakuta.nami@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nami Kakuta |
Organization
Institute of Biomedical Sciences Tokushima University Graduate School
Division name
Department of Anesthesiology
Zip code
Address
770-8503
TEL
81-88-633-7181
Homepage URL
kakuta.nami@tokushima-u.ac.jp
Sponsor or person
Institute
Institute of Biomedical Sciences Tokushima University Graduate School
Department of Anesthesiology
Institute
Department
Personal name
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
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
| 2015 | Year | 11 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | 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
| 2015 | Year | 11 | Month | 28 | Day |
Last modified on
| 2015 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023066
