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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
History of Changes
  Purpose

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.


Condition Intervention
Transient Hypertension
 Drug: Midazolam
Drug: Normal Saline Solution (NSS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Low Dose of Midazolam on Blood Pressure and Anxiety Scale in White-coat Hypertensive Dental Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Okayama University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: October 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Midazolam
Intravenous administration of midazolam at dose of 0.02mg/kg
 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.
Placebo Comparator: NSS
Intravenous administration of saline solution at dose of 0.004ml/kg as a placebo drug
 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.

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528371

Locations
Japan
Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Okayama, Japan
Sponsors and Collaborators
Okayama University
Investigators
Principal Investigator: Yoshihisa Watanabe, DDS Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
  More Information

No publications provided

Responsible Party: Yoshihisa Watanabe, Department of Dental Anesthesiology and Special Care Dentistry,Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
ClinicalTrials.gov Identifier: NCT01528371     History of Changes
Other Study ID Numbers: yoshi0112
Study First Received: January 23, 2012
Last Updated: October 1, 2012
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Okayama University:
Intravenous sedation
Midazolam
Dental treatment
White-coat hypertension
 STAI
Dental patients
Transient hypertension

Additional relevant MeSH terms:
Hypertension
Pregnancy Complications, Cardiovascular
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013