UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007066 |
|---|---|
| Receipt number | R000008324 |
| Scientific Title | The effect of low dose of midazolam on blood pressure and anxiety scale in white-coat hypertensive dental patients: a double-blind randomized controlled trial. |
| Date of disclosure of the study information | 2012/01/18 |
| Last modified on | 2012/10/02 08:12:22 |
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Basic information
Public title
The effect of low dose of midazolam on blood pressure and anxiety scale in white-coat hypertensive dental patients: a double-blind randomized controlled trial.
Acronym
The effect of low dose of midazolam on blood pressure and anxiety scale in white-coat hypertensive dental patients.
Scientific Title
The effect of low dose of midazolam on blood pressure and anxiety scale in white-coat hypertensive dental patients: a double-blind randomized controlled trial.
Scientific Title:Acronym
The effect of low dose of midazolam on blood pressure and anxiety scale in white-coat hypertensive dental patients.
Region
| Japan |
Condition
Condition
Dental patients
Classification by specialty
| Cardiology | Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intravenous sedation was used for dealing with transient hypertension, so-called white-coat hypertension, before dental treatment. Midazolam used as a sedative also has antianxiety effect, and the mechanism is guessed that it minimizes patients' stress, resulting in the stability of blood pressure. The purpose of this RCT is to evaluate the effect of low dose of midazolam on blood pressure and anxiety scale in white-coat hypertensive dental patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood pressure, heart rate, and oxygen saturation before and 2,4,6,8,10 minutes after drug administration.
Japanese version of STAI before and 10 minutes after drug administration.
Key secondary outcomes
Visual analog scale about anxiety to dental treatment.
Sedation level.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group M: Intravenous administration of midazolam at dose of 0.02mg/kg.
1. We select subject from patients for whom the doctor has ordered intravenous
sedation. Inclusion criteria is SBP>=140mmHg or DBP>=90mmHg measuring when the patient sits on dental chair and has settled down for 5 minutes. Informed consent is obtained from the patient.
2. Patient conducts Japanese version of STAI and VAS about anxiety to dental treatment.
3. We take venous line on the upper limb and inject the drug intravenously. We measure blood pressure, heart rate, and oxygen saturation every 2 minutes until 10 minutes after drug administration.
4. 10 minutes later, patient conducts Japanese version of STAI and VAS about anxiety to dental procedure again.
5.We inject an additional sedative agent and the dental treatment is started.
Study duration is from 01/Oct/2010 to 31/Mar/2013.
Interventions/Control_2
Group P: Intravenous administration of saline solution at dose of 0.004ml/kg as a placebo drug.
Method is same as group M.
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria is SBP>=140mmHg or DBP>=90mmHg measuring when the patient sits on dental chair and has settled down for 5 minutes among dental outpatients scheduling intravenous sedation with American Society of Anesthesiologists physical status I or II.
Key exclusion criteria
1.Uncontrolled or unstable hypertension
2.Secondary hypertension such as
hyperthyroidism and pheochromocytoma
3.Taking sympathomimetic drugs
4.Contraindication of midazolam such as myasthenia gravis and acute narrow-angle glaucoma
5.A pregnant woman or during lactation period
6.Psychiatric disorder such as
schizophrenia
7.Not having intelligence enough to read, understand and write a Japanese version of STAI
8.Judged unsuitable by a researcher
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Miyawaki |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Watanabe |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
Homepage URL
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 18 | 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
| 2010 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 11 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 11 | Day |
Date trial data considered complete
| 2012 | Year | 07 | Month | 13 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 13 | Day |
Last modified on
| 2012 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008324
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| Registered date | File name |
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| Registered date | File name |
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