UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of inhaled anesthetics on sedation after head and neck surgery
Title of the study (Brief title)	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	Hirotoshi Kitagawa
Organization	Shiga University of Medical Science
Division name	Department of Anesthesiology
Address	Seta-Tsukinowa, Otsu, Shiga
TEL	077-548-2281
Email	hirotosi@belle.shiga-med.ac.jp

Public contact
Name of contact person	Kan Takahashi
Organization	Shiga University of Medical Science
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000031061