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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 randomized controlled trial (RCT) is to evaluate the effect of low dose of midazolam on blood pressure and anxiety scale in white-coat hypertensive dental patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam | Active Comparator | Intravenous administration of midazolam at dose of 0.02mg/kg |
|
| NSS | Placebo Comparator | Intravenous administration of saline solution at dose of 0.004ml/kg as a placebo drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Until 10 minutes after drug administration | |
| Heart rate | Until 10 minutes after drug administration | |
| Oxygen saturation | Until 10 minutes after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale about anxiety to dental treatment | 10 minutes after drug administration | |
| Sedation level | 10 minutes after drug administration | |
| Japanese version of STAI |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshihisa Watanabe, DDS | Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | Okayama | Japan |
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| ID | Term |
|---|---|
| D059466 | White Coat Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Normal Saline Solution (NSS) | Drug |
|
|
| 10 minutes after drug administration |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |