Effect of Midazolam on White-coat Hypertensive Dental Patients

Not Applicable

Completed

• Conditions: Transient Hypertension
• Interventions: Drug: Normal Saline Solution (NSS); Drug: Midazolam

• Registration Number: NCT01528371
• Lead Sponsor: Okayama University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-08
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-01
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSS	Normal Saline Solution (NSS)	Intravenous administration of saline solution at dose of 0.004ml/kg as a placebo drug
Midazolam	Midazolam	Intravenous administration of midazolam at dose of 0.02mg/kg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences; 🇯🇵 Okayama, Japan