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Effect of Midazolam on White-coat Hypertensive Dental Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoshihisa Watanabe, Okayama University
ClinicalTrials.gov Identifier:
NCT01528371
First received: January 23, 2012
Last updated: October 1, 2012
Last verified: October 2012

January 23, 2012
October 1, 2012
October 2010
July 2012   (final data collection date for primary outcome measure)
  • Blood pressure [ Time Frame: Until 10 minutes after drug administration ] [ Designated as safety issue: Yes ]
  • Heart rate [ Time Frame: Until 10 minutes after drug administration ] [ Designated as safety issue: Yes ]
  • Oxygen saturation [ Time Frame: Until 10 minutes after drug administration ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01528371 on ClinicalTrials.gov Archive Site
  • Visual analog scale about anxiety to dental treatment [ Time Frame: 10 minutes after drug administration ] [ Designated as safety issue: No ]
  • Sedation level [ Time Frame: 10 minutes after drug administration ] [ Designated as safety issue: Yes ]
  • Japanese version of STAI [ Time Frame: 10 minutes after drug administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Midazolam on White-coat Hypertensive Dental Patients
The Effect of Low Dose of Midazolam on Blood Pressure and Anxiety Scale in 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Transient Hypertension
  • 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.
  • Active Comparator: Midazolam
    Intravenous administration of midazolam at dose of 0.02mg/kg
    Intervention: Drug: Midazolam
  • Placebo Comparator: NSS
    Intravenous administration of saline solution at dose of 0.004ml/kg as a placebo drug
    Intervention: Drug: Normal Saline Solution (NSS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01528371
yoshi0112
No
Yoshihisa Watanabe, Okayama University
Okayama University
Not Provided
Principal Investigator: Yoshihisa Watanabe, DDS Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Okayama University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP