Effect of Midazolam on White-coat Hypertensive Dental Patients

Sponsor

Okayama University (Other)

Overall Status

Completed

CT.gov ID

NCT01528371

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transient Hypertension	Drug: Midazolam Drug: Normal Saline Solution (NSS)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Midazolam Intravenous administration of midazolam at dose of 0.02mg/kg	Drug: Midazolam 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.
Placebo Comparator: NSS Intravenous administration of saline solution at dose of 0.004ml/kg as a placebo drug	Drug: Normal Saline Solution (NSS) 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.

Arm

Intervention/Treatment

Active Comparator: Midazolam

Intravenous administration of midazolam at dose of 0.02mg/kg

Drug: Midazolam

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.

Placebo Comparator: NSS

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

Drug: Normal Saline Solution (NSS)

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None 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

Other Study ID Numbers:

yoshi0112

First Posted:

Feb 8, 2012

Last Update Posted:

Oct 3, 2012

Last Verified:

Oct 1, 2012

Keywords provided by Yoshihisa Watanabe, Department of Dental Anesthesiology and Special Care Dentistry,Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University

Intravenous sedation

Midazolam

Dental treatment

White-coat hypertension

STAI

Dental patients

Transient hypertension

Additional relevant MeSH terms:

Hypertension

Midazolam

Study Results

No Results Posted as of Oct 3, 2012