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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030227
Receipt No. R000031061
Scientific Title Effects of inhaled anesthetics on sedation after head and neck surgery
Date of disclosure of the study information 2017/12/10
Last modified on 2018/12/03

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Basic information
Public title Effects of inhaled anesthetics on sedation after head and neck surgery
Acronym Sedation after head and neck surgery with inhaled anesthetics
Scientific Title Effects of inhaled anesthetics on sedation after head and neck surgery
Scientific Title:Acronym Sedation after head and neck surgery with inhaled anesthetics
Region
Japan

Condition
Condition Post head abd neck surgery
Classification by specialty
Oto-rhino-laryngology Intensive care medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate efficacy and safety of inhaled anesthetics, sevoflurane during sedation after head and neck surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood test(complete blood count, liver function, renal function, electrolytes, coagulation)
Key secondary outcomes Emergence time
Duration of ICU stay
Dose of sevoflurane, Duration of administration of sevoflurane
Richmond agitation sedation scale, verval rating scale
Number of times of additional sedative and analgegic agents
Incidence of respiratory surpression
Hemodynamic changes
Dose of vasopressor and antihypertensive drugs, Number of times of vasopressor and antihypertensive drugs use
Incidence of agitation and delirium, nausea and vomitting, shivering
Arterial blood gas analysis

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 After surgery, inhaled anesthetics, sevoflurane will be administered in 24 hours.
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 Postoperative patients after head and neck surgery who require mechanical ventilation in the ICU
Key exclusion criteria In case of risk of the patients will be increased by the study or the data cannnot be obtained.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotoshi Kitagawa
Organization Shiga University of Medical Science
Division name Department of Anesthesiology
Zip code
Address Seta-Tsukinowa, Otsu, Shiga
TEL 077-548-2281
Email hirotosi@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kan Takahashi
Organization Shiga University of Medical Science
Division name Department of Anesthesiology
Zip code
Address Seta-Tsukinowa, Otsu, Shiga
TEL 077-548-2281
Homepage URL
Email kan@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Shiga University of Medical Science
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
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
2017 Year 12 Month 10 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 Completed
Date of protocol fixation
2017 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 02 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031061

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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