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Effect of Midazolam on White-coat Hypertensive Dental Patients

NCT01528371 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-10-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Okayama University

    lead OTHER

Principal Investigators

  • Yoshihisa Watanabe, DDS · Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01528371 on ClinicalTrials.gov