UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Salivary amylase stress analysis; sedation with midazolam during bronchoscopy
Title of the study (Brief title)	Salivary amylase stress analysis; sedation with midazolam during bronchoscopy
Region	Japan

Condition
Condition	Subjects of bronchoscopy; cases of suspected to malignant disease
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Consider the following items in order to implement safer bronchoscopy. 1.measuring biomarkers (salivary amylase) to examine the stress of bronchoscopy 2.measuring Bispectral Index (BIS) and electromyography (EMG) to examine the degree of sedation 3.conducting a survey patients after bronchoscopy to examine the degree of patient distress
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.salivary amylase levels before and after bronchoscopy 2. Bispectral Index (BIS) and electromyography (EMG) during bronchoscopy 3.patient pain questionnaire after bronchoscopic
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Interventions; sedation with midazolam during bronchoscopy.
Interventions/Control_2	Control; not use midazolam.
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	18 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. subject of a bronchoscopy 2. cases written informed consent was obtained 3. cases of suspected to malignant disease
Key exclusion criteria	patients who were deemed inappropriate to the subject of this study by attending physician
Target sample size	110

Research contact person
Name of lead principal investigator	takamasa hotta
Organization	Shimane University Faculty of Medicine
Division name	Department of Biochemistry
Address	89-1 Enya-cho Izumo Shimane 693-8501 JAPAN
TEL
Email

Public contact
Name of contact person
Organization	Shimane University Faculty of Medicine
Division name	Department of Internal Medicine, Division of Medical Oncology and Respiratory Medicine
Address
TEL
Homepage URL
Email	hotta.takamasa@gmail.com

Sponsor
Institute	Department of Internal Medicine, Division of Medical Oncology and Respiratory Medicine
Institute
Department

Funding Source
Organization	Department of Internal Medicine, Division of Medical Oncology and Respiratory Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 06 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 04 Month 22 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 06 Month 19 Day
Last modified on	2016 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012881