Transient Hypertension
Conditions
Keywords
Intravenous sedation, Midazolam, Dental treatment, White-coat hypertension, STAI, Dental patients, Transient hypertension
Brief summary
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.
Interventions
DRUGMidazolam
1. 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. 2. Patient conducts Japanese version of STAI and VAS about anxiety to dental treatment. 3. 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. 4. 10 minutes later, patient conducts Japanese version of STAI and VAS about anxiety to dental procedure again. 5. Investigators inject an additional sedative agent and the dental treatment is started.
1. 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. 2. Patient conducts Japanese version of STAI and VAS about anxiety to dental treatment. 3. 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. 4. 10 minutes later, patient conducts Japanese version of STAI and VAS about anxiety to dental procedure again. 5. Investigators inject an additional sedative agent and the dental treatment is started.
Sponsors
Okayama University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
Yes
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
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Japan
Outcome results
None listed