Effect of Midazolam on White-coat Hypertensive Dental Patients

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Low Dose of Midazolam on Blood Pressure and Anxiety Scale in White-coat Hypertensive Dental Patients

Conditions
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Transient Hypertension

Intervention / Treatment
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* Drug: Midazolam
* Drug: Normal Saline Solution (NSS)


Participation Criteria
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Eligibility Criteria
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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: Uncontrolled or unstable hypertension Secondary hypertension such as hyperthyroidism and pheochromocytoma Taking sympathomimetic drugs Contraindication of midazolam such as myasthenia gravis and acute narrow-angle glaucoma A pregnant woman or during lactation period Psychiatric disorder such as schizophrenia Not having intelligence enough to read, understand and write a Japanese version of STAI Judged unsuitable by a researcher

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midazolam<br>Intravenous administration of midazolam at dose of 0.02mg/kg | Drug: Midazolam<br>* Investigators 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. Patient conducts Japanese version of STAI and VAS about anxiety to dental treatment. Investigators take venous line on the upper limb and inject the drug (midazolam at dose of 0.02mg/kg) intravenously. Investigators measure blood pressure, heart rate, and oxygen saturation every 2 minutes until 10 minutes after drug administration. 10 minutes later, patient conducts Japanese version of STAI and VAS about anxiety to dental procedure again. Investigators inject an additional sedative agent and the dental treatment is started.<br>|
| Placebo Comparator: NSS<br>Intravenous administration of saline solution at dose of 0.004ml/kg as a placebo drug | Drug: Normal Saline Solution (NSS)<br>* Investigators 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. Patient conducts Japanese version of STAI and VAS about anxiety to dental treatment. Investigators take venous line on the upper limb and inject the drug (saline solution at dose of 0.004ml/kg) intravenously. Investigators measure blood pressure, heart rate, and oxygen saturation every 2 minutes until 10 minutes after drug administration. 10 minutes later, patient conducts Japanese version of STAI and VAS about anxiety to dental procedure again. Investigators inject an additional sedative agent and the dental treatment is started.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 10 minutes after drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravenous sedation, Midazolam, Dental treatment, White-coat hypertension, STAI, Dental patients, Transient hypertension