Effect of Midazolam on White-coat Hypertensive Dental Patients

Transient Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528371
• Other study ID #: yoshi0112
• Status: Completed
• Phase: N/A
• First received: January 23, 2012
• Last updated: October 1, 2012
• Start date: October 2010
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: Okayama University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypertension
• Transient Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Japan	Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences	Okayama

Sponsors (1)

Lead Sponsor	Collaborator
Okayama University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		Until 10 minutes after drug administration	Yes
Primary	Heart rate		Until 10 minutes after drug administration	Yes
Primary	Oxygen saturation		Until 10 minutes after drug administration	Yes
Secondary	Visual analog scale about anxiety to dental treatment		10 minutes after drug administration	No
Secondary	Sedation level		10 minutes after drug administration	Yes
Secondary	Japanese version of STAI		10 minutes after drug administration	No