UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective randomized controlled trial on efficacy and safety by combined analgesics at sedative bronchoscopy using a BIS monitor
Title of the study (Brief title)	Prospective randomized controlled trial on efficacy and safety by combined analgesics at sedative bronchoscopy using a BIS monitor
Region	Japan

Condition
Condition	Peripheral lung lesion
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the additional effect on safety and patient's satisfaction with analgesics combined with sedative bronchoscopy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The patient satisfaction score 2 hours after bronchoscopy using a visual analogue scale (VAS)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Administration of midazolam during bronchoscopy
Interventions/Control_2	Administration of midazolam and fentanyl during bronchoscopy
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Over 20 years old and under 90 years 2) Adaptation of bronchoscopy (EBUS-GS) 3) Written consent has been obtained
Key exclusion criteria	1) History of severe drug allergy 2) Contraindications to use of midazolam and fentanyl 3) Using any opioids 4) Severe hypoxemia or hypercapnia 5) History of severe heart, lung, liver, kidney, neuromuscular disease 6) History of epilepsy 7) History of symptomatic cerebral infarction 8) During pregnancy or possible pregnancy 9) Emergency procedure 10) Bronchoscopy other than EBUS-GS 11) Other conditions inappropriate for participating in the study
Target sample size	100

Research contact person
Name of lead principal investigator	Naohiko Hamaguchi
Organization	Ehime University School of Medicine
Division name	Department of Cardiology, Pulmonology, Hypertension and Nephrology
Address	Shitsukawa, Toon, Ehime
TEL	089-960-5303
Email	guri0531@m.ehime-u.ac.jp

Public contact
Name of contact person	Takahide Kato
Organization	Ehime University School of Medicine
Division name	Department of Cardiology, Pulmonology, Hypertension and Nephrology
Address	Shitsukawa, Toon, Ehime
TEL	089-960-5303
Homepage URL
Email	kato.takahide.tn@ehime-u.ac.jp

Sponsor
Institute	Ehime University
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)

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	愛媛大学医学部附属病院（愛媛県）

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 03 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 04 Month 23 Day
Anticipated trial start date	2018 Year 05 Month 03 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	2018 Year 05 Month 03 Day
Last modified on	2018 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037020