UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Application of remifentanil to intravenous sedation in the patients compromised with severe gag reflex
Title of the study (Brief title)	Application of remifentanil under intravenous sedation to the patients compromised with severe gag reflex
Region	Japan

Condition
Condition	gag reflex in dental procedure
Classification by specialty	Anesthesiology Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to identify optimal remifentanil dose to avoid a severe gag reflex dureing dental procedure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient and dentist satisfaction by using remifentanil in intravenous sedation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Respiratory rate is maintained more than 9 breaths/min. The dose of midazolam and propofol were titrated according to the OAA/S Scale (Observers Assessment of Alertness/Sedation Scale).
Interventions/Control_2	In addition to Intervention 1, remifentanil(0.06micro-g/kg/min)is additionally infused.
Interventions/Control_3	In addition to Intervention 1, remifentanil(0.08micro-g/kg/min)is additionally infused.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Physical status of the enrolled patients are American Society of Anesthesiologists(ASA) class 1-2, aged 20 years old or above, who cannot torelate dental treatment because of gag reflex.
Key exclusion criteria	Exclusion criteria included allergies to remifentanil, fentanyl-related, propofol and midazolam, used than other analgesic drug and sedative drug propofol and remifentanil, ASA class 3 or over, child and disability person.
Target sample size	48

Research contact person
Name of lead principal investigator	Mutsumi Nonaka
Organization	Showa University School of Dentistry
Division name	Depertment of perioperative Medicine, Division of Anesthesiology
Address	2-1-1 Kitasenzoku, Ota-ku, Tokyo
TEL	03-3787-1151
Email	nmutsumi@dent.showa-u.ac.jp

Public contact
Name of contact person	Mutsumi Nonaka
Organization	Showa University School of Dentistry
Division name	Depertment of perioperative Medicine, Division of Anesthesiology
Address	2-1-1 Kitasenzoku, Ota-ku, Tokyo
TEL	03-3787-1151
Homepage URL
Email	nmutsumi@dent.showa-u.ac.jp

Sponsor
Institute	Depertment of perioperative Medicine, Division of Anesthesiology,Showa University School of Dentistry
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

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 25 Day
Anticipated trial start date	2014 Year 04 Month 08 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	2017 Year 01 Month 30 Day
Last modified on	2017 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016578