Clinical Trial: Effect of Midazolam on White-coat Hypertensive Dental Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Okayama University

Current Primary Outcome:

  • Blood pressure [ Time Frame: Until 10 minutes after drug administration ]
  • Heart rate [ Time Frame: Until 10 minutes after drug administration ]
  • Oxygen saturation [ Time Frame: Until 10 minutes after drug administration ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visual analog scale about anxiety to dental treatment [ Time Frame: 10 minutes after drug administration ]
  • Sedation level [ Time Frame: 10 minutes after drug administration ]
  • Japanese version of STAI [ Time Frame: 10 minutes after drug administration ]


Original Secondary Outcome: Same as current

Information By: Okayama University

Dates:
Date Received: January 23, 2012
Date Started: October 2010
Date Completion:
Last Updated: October 1, 2012
Last Verified: October 2012