UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of recovery time after intravenous sedation using dexmedetomidine in combination with propofol or midazolam
Acronym	Comparison of intravenous sedation using dexmedetomidine in combination with propofol or midazolam
Scientific Title	Comparison of recovery time after intravenous sedation using dexmedetomidine in combination with propofol or midazolam
Scientific Title:Acronym	Comparison of intravenous sedation using dexmedetomidine in combination with propofol or midazolam
Region	Japan

Condition
Condition	Require dental procedure under intravenous sedation
Classification by specialty	Anesthesiology Oral surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare recovery time and body movements between dexmedetomidine-midazolam and dexmedetomidine-propofol sedation in patients undergo dental procesure under intravenous sedation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time from the end of the sedatives administration until the Romberg test is successfully performed.
Key secondary outcomes	Time from the end of the sedatives administration until achieving an Aldrete score of 9 or 10. Time from the end of the sedatives administration until patients possible to sit. Time from the end of the sedatives administration until patients possible to stand up.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Sedation with dexmedetomidine and propofol
Interventions/Control_2	Sedation with dexmedetomidine and 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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Require dental procedure under intravenous sedation 2. From 20 to 65 years of age 3. American Society of Anesthesiologists (ASA) physical status 1 or 2
Key exclusion criteria	1. A history of allergic reactions to the drugs used in this study 2. Allergic reaction to yolk and soy 3. Hepatic or renal dysfunction 4. Maternal and nursing women 5. Circulatory or respiratory dysfunction 6. Acute narrow-angle glaucoma 7. Myasthenia gravis 8. Receiving HIV protease inhibitors or HIV reverse transcriptase inhibitors 9. Prescribed antipsychotics 10. brain disorder 11. Severe obesity, micrognathia, tonsillar hypertrophy, sleep apnea syndrome
Target sample size	54

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Hanamoto
Organization	Osaka University Graduate School of Dentistry
Division name	Department of Dental Anesthesiology
Zip code	565-0871
Address	1-8, Yamadaoka, suita, Osaka, Japan
TEL	06-6879-2972
Email	hanamoto@dent.osaka-u.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Hanamoto
Organization	Department of Dental Anesthesiology
Division name	1-8, Yamadaoka, suita, Osaka, Japan
Zip code	565-0871
Address	1-8, Yamadaoka, suita, Osaka, Japan
TEL	0668792972
Homepage URL
Email	hanamoto@dent.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Dentistry
Institute
Department

Funding Source
Organization	The Ministry of Education,Culture,Sports,Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Graduate School of Dentistry General Affairs Section
Address	1-8, Yamadaoka, suita, Osaka, Japan
Tel	06-6879-2831
Email	si-soumu-syomu@office.osaka-u.ac.jp

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	2020 Year 03 Month 04 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	2020 Year 01 Month 27 Day
Date of IRB	2020 Year 02 Month 07 Day
Anticipated trial start date	2020 Year 03 Month 04 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 02 Day
Last modified on	2022 Year 09 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045223