Transient HypertensionNCT01528371
Effect of Midazolam on White-coat Hypertensive Dental Patients
A study testing Midazolam and Normal Saline Solution (NSS) in people with Transient Hypertension, run by Okayama University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Transient Hypertension
- What is being tested?
- Midazolam and Normal Saline Solution (NSS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Okayama
About this study
Official title: 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.
- Conditions
- Transient Hypertension
- Being tested
- Midazolam, Normal Saline Solution (NSS)
- Keywords
- Intravenous sedation, Midazolam, Dental treatment, White-coat hypertension, STAI, Dental patients, Transient hypertension
- Medical subject headings
- White Coat Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Active comparator | Intravenous administration of midazolam at dose of 0.02mg/kg Receives: Drug: Midazolam |
| NSS | Placebo comparator | Intravenous administration of saline solution at dose of 0.004ml/kg as a placebo drug Receives: Drug: Normal Saline Solution (NSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: Until 10 minutes after drug administration
Heart rate
Measured: Until 10 minutes after drug administration
Oxygen saturation
Measured: Until 10 minutes after drug administration
Secondary outcomes (3)
Visual analog scale about anxiety to dental treatment
Measured: 10 minutes after drug administration
Sedation level
Measured: 10 minutes after drug administration
Japanese version of STAI
Measured: 10 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startOct 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okayama University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshihisa Watanabe, Okayama University
- Investigators
- Yoshihisa Watanabe, DDS, Principal investigator, Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528371
- Sponsor's protocol ID
- yoshi0112
- Status last verified
- Oct 2012
- First submitted
- 23 Jan 2012
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Dose of Midazolam on Blood Pressure and Anxiety Scale in White-coat Hypertensive Dental Patients
- ClinicalTrials.gov ID
- NCT01528371
- Acronym / sponsor ID
- yoshi0112
- Conditions
- Transient Hypertension
- Keywords
- Intravenous sedation, Midazolam, Dental treatment, White-coat hypertension, STAI, Dental patients, Transient hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Okayama UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Active comparator | Drug: MidazolamIntravenous administration of midazolam at dose of 0.02mg/kg |
| NSS | Placebo comparator | Drug: Normal Saline Solution (NSS)Intravenous administration of saline solution at dose of 0.004ml/kg as a placebo drug |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam1. 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 | Midazolam |
| 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. | Drug | NSS |
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshihisa Watanabe, DDS principal investigator
Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam and Normal Saline Solution (NSS) in people with Transient Hypertension, run by Okayama University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Until 10 minutes after drug administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.