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

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.

Study Overview

• Status: Completed
• Conditions: Transient Hypertension
• Intervention / Treatment: Drug: Midazolam; Drug: Normal Saline Solution (NSS)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Midazolam; Intravenous administration of midazolam at dose of 0.02mg/kg	Drug: Midazolam; 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.
Placebo Comparator: NSS; Intravenous administration of saline solution at dose of 0.004ml/kg as a placebo drug	Drug: Normal Saline Solution (NSS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Okayama University
• Investigators: Principal Investigator: Yoshihisa Watanabe, DDS, Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 23, 2012
• First Submitted That Met QC Criteria: February 7, 2012
• First Posted (Estimate): February 8, 2012

Study Record Updates

• Last Update Posted (Estimate): October 3, 2012
• Last Update Submitted That Met QC Criteria: October 1, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Intravenous sedation; Midazolam; Dental treatment; White-coat hypertension; STAI; Dental patients; Transient hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: yoshi0112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No