Transesophageal EchocardiographyNCT01444976
The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability
A study testing local anesthesia, hypnosis and Midazolam in people with Transesophageal Echocardiography, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
There is no ideal sedation technique that can be used during Transesophageal Echocardiography (TEE), and the data concerning the effects of available sedation techniques on Heart Rate Variability (HRV) are limited. Read more about this study
- Who is it for?
- Ages 18 to 83 years
- Conditions the study is for
- Transesophageal Echocardiography
- What is being tested?
- local anesthesia, hypnosis and Midazolam
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2010to Mar 2011
- 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 18 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a need of transesophageal echocardiography
Who cannot join
- Heart failure
- Bad overall condition
- Arrhythmia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Bakırköy, Istanbul, 34147
About this study
Official title: The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability:A Comparison of Hypnotic Sedation With Medical Sedation
There is no ideal sedation technique that can be used during Transesophageal Echocardiography (TEE), and the data concerning the effects of available sedation techniques on Heart Rate Variability (HRV) are limited. In this study the investigators aimed at comparing the effects of sedation through hypnotherapy with medical sedation achieved by midazolam on HRV.
Read the detailed description
Seventy-six patients with an indication of TEE will be recruited, the age range will be 18-83 years. In Group Topical (T) there are 26 patients who had the procedure under topical pharyngeal anesthesia, in Group Midazolam (D) there are 25 patients who will receive midazolam and in Group H there are 27 patients receiving hypnosis. All patients will have an IV access; throughout the procedure heart rate, rhythm ECG, peripheric O2 saturation will be monitored with a non-invasive monitor, blood pressure measurements were taken every 3 minutes. Rhythm Holter recordings will be obtained from all patients and TEE will be performed.
- Conditions
- Transesophageal Echocardiography
- Being tested
- local anesthesia, hypnosis, Midazolam
- Keywords
- age range of 18-83
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anesthesiaDrug
patients will receive only topical anesthesia with 1% lidocaine
hypnosisBehavioural
Hypnosis will be performed by the same anesthesiologist according to indirect Erickson's method
MidazolamDrug
Before insertion of the probe, the patients will be sedated with midazolam at a dose of 0,.05 mg/kg iv (to achieve a Ramsay Sedation Score of 2-3). If needed, additional iv doses (0.005 mg/kg) were given during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| topical pharyngeal anesthesia | Active comparator | There were 26 patients who had the procedure under topical pharyngeal anesthesia. Receives: Drug: local anesthesia; Behavioral: hypnosis |
| midazolam | Active comparator | There were 25 patients who received midazolam. Receives: Behavioral: hypnosis; Drug: Midazolam |
| hypnosis | No intervention | There were 27 patients receiving hypnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypnotic sedation
Contrary to sedation with midazolam; when hypnosis is used for sedation in TEE patients, autonomic cardiac tone is modified to a significant extent. Hypnotic sedation achieves this by increasing the parasympathetic activity, decreasing the sympathetic activity and changing the sympathovagal interaction balance.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startDec 2010
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Murat Gonenc, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444976
- Sponsor's protocol ID
- yuksel-dogan-2011
- Status last verified
- Sep 2011
- First submitted
- 26 May 2011
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability:A Comparison of Hypnotic Sedation With Medical Sedation
- ClinicalTrials.gov ID
- NCT01444976
- Acronym / sponsor ID
- yuksel-dogan-2011
- Conditions
- Transesophageal Echocardiography
- Keywords
- age range of 18-83
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- Dec 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 3 Oct 2011 (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.
There is no ideal sedation technique that can be used during Transesophageal Echocardiography (TEE), and the data concerning the effects of available sedation techniques on Heart Rate Variability (HRV) are limited. In this study the investigators aimed at comparing the effects of sedation through hypnotherapy with medical sedation achieved by midazolam on HRV.
Detailed description
Seventy-six patients with an indication of TEE will be recruited, the age range will be 18-83 years. In Group Topical (T) there are 26 patients who had the procedure under topical pharyngeal anesthesia, in Group Midazolam (D) there are 25 patients who will receive midazolam and in Group H there are 27 patients receiving hypnosis. All patients will have an IV access; throughout the procedure heart rate, rhythm ECG, peripheric O2 saturation will be monitored with a non-invasive monitor, blood pressure measurements were taken every 3 minutes. Rhythm Holter recordings will be obtained from all patients and TEE will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| topical pharyngeal anesthesia | Active comparator | Drug: local anesthesia, Behavioral: hypnosisThere were 26 patients who had the procedure under topical pharyngeal anesthesia. |
| midazolam | Active comparator | Behavioral: hypnosis, Drug: MidazolamThere were 25 patients who received midazolam. |
| hypnosis | No intervention | –There were 27 patients receiving hypnosis. |
Who may qualify
- Ages
- 18 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a need of transesophageal echocardiography
Key exclusion criteria (3 listed)
- Heart failure
- Bad overall condition
- Arrhythmia
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 |
|---|---|---|
| local anesthesiapatients will receive only topical anesthesia with 1% lidocaine | Drug | topical pharyngeal anesthesia |
| hypnosisHypnosis will be performed by the same anesthesiologist according to indirect Erickson's method | Behavioural | midazolam, topical pharyngeal anesthesia |
| MidazolamBefore insertion of the probe, the patients will be sedated with midazolam at a dose of 0,.05 mg/kg iv (to achieve a Ramsay Sedation Score of 2-3). If needed, additional iv doses (0.005 mg/kg) were given during the procedure. | Drug | midazolam |
Primary outcome
Hypnotic sedation
Time frame: two months
Contrary to sedation with midazolam; when hypnosis is used for sedation in TEE patients, autonomic cardiac tone is modified to a significant extent. Hypnotic sedation achieves this by increasing the parasympathetic activity, decreasing the sympathetic activity and changing the sympathovagal interaction balance.
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 2011.
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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.
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?
A study testing local anesthesia, hypnosis and Midazolam in people with 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 1 inclusion and 3 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 2011. 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?
Hypnotic sedation (time frame: two months). 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 2011.