Effect of Midazolam on White-coat Hypertensive Dental Patients

NCT01528371 | Completed

• 1 other identifier: yoshi0112
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Transient Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

Intravenous administration of midazolam at dose of 0.02mg/kg

Drug: Midazolam

NSS

PLACEBO COMPARATOR

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

Drug: Normal Saline Solution (NSS)

Interventions

Midazolam 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.

Midazolam

Normal Saline Solution (NSS) 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.

NSS

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Uncontrolled or unstable hypertension
• Secondary hypertension such as hyperthyroidism and pheochromocytoma
• Taking sympathomimetic drugs
• Contraindication of midazolam such as myasthenia gravis and acute narrow-angle glaucoma
• A pregnant woman or during lactation period
• Psychiatric disorder such as schizophrenia
• Not having intelligence enough to read, understand and write a Japanese version of STAI
• Judged unsuitable by a researcher

Sponsors & Collaborators

• Okayama University: lead

Study Sites (1)

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

Okayama, Japan

Location

MeSH Terms

Conditions

White Coat Hypertension

Interventions

Midazolam; Saline Solution

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yoshihisa Watanabe, DDS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Dental Anesthesiology and Special Care Dentistry,Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: February 8, 2012
• Study Start: October 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 3, 2012

Record last verified: 2012-10

Locations

JP (1)