UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030227 |
|---|---|
| Receipt number | 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 09:29:49 |
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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
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
kan@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031061
