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Effect of Midazolam on White-coat Hypertensive Dental Patients

NCT ID: NCT01528371

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Transient Hypertension

Keywords

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Intravenous sedation Midazolam Dental treatment White-coat hypertension STAI Dental patients Transient hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Midazolam

Intravenous administration of midazolam at dose of 0.02mg/kg

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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.

NSS

Intravenous administration of saline solution at dose of 0.004ml/kg as a placebo drug

Group Type PLACEBO_COMPARATOR

Normal Saline Solution (NSS)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Okayama University

OTHER

Sponsor Role lead

Responsible Party

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Yoshihisa Watanabe

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoshihisa Watanabe, DDS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Okayama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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yoshi0112

Identifier Type: -

Identifier Source: org_study_id