NCT01528371

Effect of Midazolam on White-coat Hypertensive Dental Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Okayama University · Academic / Other
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Transient Hypertension

Interventions

Type	Name	Description
DRUG	Midazolam	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.
DRUG	Normal Saline Solution (NSS)	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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-02-08
• Last updated: 2012-10-03

Locations

1 site across 1 country: Japan