UMIN-CTR Clinical Trial

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
Email	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
Email	fujiik@topaz.ocn.ne.jp

Sponsor
Institute	Wakayama Medical University Department of Anesthesiology
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014324

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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