UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039668
Receipt number R000045223
Scientific Title Comparison of recovery time after intravenous sedation using dexmedetomidine in combination with propofol or midazolam
Date of disclosure of the study information 2020/03/04
Last modified on 2022/09/02 19:19:01

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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 or person

Institute

Osaka University Graduate School of Dentistry

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045223


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name