UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012321 |
|---|---|
| Receipt number | R000014324 |
| Scientific Title | A prospective observational study of the factors affecting the quality of dreams during general anesthesia |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2018/03/24 23:52:22 |
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Basic information
Public title
A prospective observational study of the factors affecting the quality of dreams during general anesthesia
Acronym
A prospective observational study of the factors affecting the quality of dreams during general anesthesia
Scientific Title
A prospective observational study of the factors affecting the quality of dreams during general anesthesia
Scientific Title:Acronym
A prospective observational study of the factors affecting the quality of dreams during general anesthesia
Region
| Japan |
Condition
Condition
The patients under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine whether the preoperative and intraoperative factors including general anesthetics, such as propofol, sevoflurane, or desflurane, can affect the quality of dreams during general anesthesia.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of dreams and the quality of dreams during general anesthesia
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
ASA physical status P1-P3 patients scheduled for elective surgery under general anesthesia
P1 A normal healthy patient
P2 A patient with mild systemic disease
P3 A patient with severe systemic disease
P4 A patient with severe systemic disease that is a constant threat to life
P5 A moribund patient who is not expected to survive without the operation
P6 A declared brain-dead patient whose organs are being removed for donor purpose
Key exclusion criteria
1)Age of younger than 20 years old
2)Presence of delirium or dementia
3)Patients who cannot answer the interview questions, such as intubated patients
4)Inappropriate for the study judged by the physicians
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Fujii |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
Address
811-1 Kimiidera, Wakayama, Wakayama 641-0012, Japan
TEL
073-441-0611
fujiik@topaz.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Fujii |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
Address
811-1 Kimiidera, Wakayama, Wakayama 641-0012, Japan
TEL
073-441-0611
Homepage URL
fujiik@topaz.ocn.ne.jp
Sponsor or person
Institute
Wakayama Medical University
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | 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
The quality of dreams under general anesthesia is different from that in natural sleep. However, the factors affecting the quality of dreams during general anesthesia have not been clarified. The aim of this study is to evaluate the relationship between the quality of dreams and the perioperative factors such as patients' characteristics, anesthetic agents, and anti-emetics.
Management information
Registered date
| 2013 | Year | 11 | Month | 17 | Day |
Last modified on
| 2018 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014324
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
