Clinical Indications for Transesophageal EchocardiographyNCT01749475
Hypnosis vs Midazolam for Sedation for TEE
An observational study of Clinical Indications for Transesophageal Echocardiography, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Most of the reports on hypnosis in the literature have focused on pain control during minor operations. With this study we aimed to evaluate the role of hypnosis on sedation for transesophageal echocardiography and compare it with commonly used sedative midazolam. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Clinical Indications for Transesophageal Echocardiography
- What is being tested?
- Midazolam and hypnotherapy
- Type of treatment
- Injection or infusion
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2010to Sep 2010
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitting to cardiology department for transesophageal echocardiography (TEE)
Who may be able to join
- indications for TEE
- American Society of Anesthesiology (ASA) physical status I-III
Who cannot join
- mental illness,
- psychotropic medication use,
- hypersensitivity to drugs
- a body mass index over 30.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr Sadi Konuk Training Hospital
Istanbul
About this study
Official title: Hypnosis for Sedation in Transesophageal Echocardiography: Comparison With Midazolam
Most of the reports on hypnosis in the literature have focused on pain control during minor operations. With this study we aimed to evaluate the role of hypnosis on sedation for transesophageal echocardiography and compare it with commonly used sedative midazolam.
- Being tested
- Midazolam, hypnotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
The patients will be given 0.05mg/kg iv midazolam just before monitorization. During probing, in case of intolerance to the insertion of the probe, the increments of midazolam with 0.005mg/kg doses will be given.
hypnotherapyOther
A first hypnotic induction will be carried out the day before the procedure, next day, fifteen minutes before the procedure, a new induction will be performed.
| Study group | Role | What they receive |
|---|---|---|
| midazolam | Not described Receives: Drug: Midazolam | |
| hypnosis | Not described Receives: Other: hypnotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedative effects of hypnotherapy and the drug "midazolam" indicated by anxiety scores and bispectral index (BIS) monitoring
Measured: during transesophageal echocardiography
Secondary outcomes (1)
measurement of alertness after sedation with continuous performance test (CPT)
Measured: the same time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Indications for Transesophageal EchocardiographyStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749475
- Sponsor's protocol ID
- HYPTEE
- Status last verified
- Feb 2013
- First submitted
- 12 Dec 2012
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis for Sedation in Transesophageal Echocardiography: Comparison With Midazolam
- ClinicalTrials.gov ID
- NCT01749475
- Acronym / sponsor ID
- HYPTEE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Dec 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.
Most of the reports on hypnosis in the literature have focused on pain control during minor operations. With this study we aimed to evaluate the role of hypnosis on sedation for transesophageal echocardiography and compare it with commonly used sedative midazolam.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midazolam | – | Drug: Midazolam |
| hypnosis | – | Other: hypnotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitting to cardiology department for transesophageal echocardiography (TEE)
Key inclusion criteria (2 listed)
- indications for TEE
- American Society of Anesthesiology (ASA) physical status I-III
Key exclusion criteria (4 listed)
- mental illness,
- psychotropic medication use,
- hypersensitivity to drugs
- a body mass index over 30.
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 |
|---|---|---|
| MidazolamThe patients will be given 0.05mg/kg iv midazolam just before monitorization. During probing, in case of intolerance to the insertion of the probe, the increments of midazolam with 0.005mg/kg doses will be given. | Drug | midazolam |
| hypnotherapyA first hypnotic induction will be carried out the day before the procedure, next day, fifteen minutes before the procedure, a new induction will be performed. | Other | hypnosis |
Primary outcome
Sedative effects of hypnotherapy and the drug "midazolam" indicated by anxiety scores and bispectral index (BIS) monitoring
Time frame: during transesophageal echocardiography
1 secondary outcome
measurement of alertness after sedation with continuous performance test (CPT)
Time frame: the same time frame
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 1 Mar 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Indications for Transesophageal Echocardiography, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 1 Mar 2013. 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 Turkey (Türkiye). 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. 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?
Sedative effects of hypnotherapy and the drug "midazolam" indicated by anxiety scores and bispectral index (BIS) monitoring (time frame: during transesophageal echocardiography). 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 1 Mar 2013.