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Completed

NCT Number: NCT01528371

Effect of Midazolam on 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.

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Key information

Conditions

Transient Hypertension Cardiovascular Diseases Hypertension Vascular Diseases White Coat Hypertension

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Okayama, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

midazolam

Drug
  • 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)

Drug
  • 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.

Primary outcomes

  1. Blood pressure

    Time frame: Until 10 minutes after drug administration

  2. Heart rate

    Time frame: Until 10 minutes after drug administration

  3. Oxygen saturation

    Time frame: Until 10 minutes after drug administration

Secondary outcomes

  1. Visual analog scale about anxiety to dental treatment

    Time frame: 10 minutes after drug administration

  2. Sedation level

    Time frame: 10 minutes after drug administration

  3. Japanese version of STAI

    Time frame: 10 minutes after drug administration

Sponsors and collaborators

Lead sponsor

Okayama University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2012
Registry last updated
Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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