Anesthesia; Adverse EffectPhase 4NCT02062333
The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea
A Phase 4 study testing Dexmedetomidine and esmolol in people with Anesthesia; Adverse Effect and Reflex, Abnormal, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to find the Effects of Anesthetics Used in Hypotensive Anesthesia on Stapes Reflex and Distortion Product Auto Acoustic Emission. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia; Adverse Effect, Reflex, Abnormal, Tinnitus, Spontaneous Oto-Acoustic Emission
- What is being tested?
- Dexmedetomidine and esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Nov 2014
- Phase
- Phase 4
- 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
Who may be able to join
- 18-65 age
- American Society of Anaesthesiologists physical status classification (ASA)1-2
- tympanoplasty surgery
- patients with normal stapes reflexes
Who cannot join
- hypertension
- drug allergy
- cardiac problems
- pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri Education and Research Hospital
Kayseri, 38039
About this study
The aim of this study is to find the Effects of Anesthetics Used in Hypotensive Anesthesia on Stapes Reflex and Distortion Product Auto Acoustic Emission.
Read the detailed description
This study was aimed at evaluating the effects of dexmedetomidine and esmolol on stapes reflex and distortion product auto acoustic emission. the stapes reflex and auto acoustic emission are of considerable diagnostic significances in otolaryngology this are objective methods for the assessment of auditory function.
- Being tested
- Dexmedetomidine, esmolol
- Keywords
- dexmedetomidine, esmolol, stapes reflex
- Medical subject headings
- Reflex, Abnormal, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
1 mcg/kg dexmedetomidine is applied bolus and 0.2 mcg/kg/h dexmedetomidine is applied iv infusion
esmololDrug
Also called breviblock
500 mcg/kg brevibloc is applied bolus and 100 mcg/kg/h iv infusion
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Active comparator | 0,4-0,8 µg./kg./h dexmedetomidine Receives: Drug: Dexmedetomidine |
| esmolol | Active comparator | 100- 300 µg./kg./min esmolol Receives: Drug: esmolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
distortion product auto acoustic emission
distortion product measurements will be performed in 1001, 1501, 2002, 3003, 4004, 6006, 7996 Hz frequencies and change from baseline in distortion product measurements at postoperative 1 day
Measured: postoperative 1 day
Secondary outcomes (1)
stapes reflex
stapes muscle reflex measurements will be performed by electrical impedance. data will be taken as graphics. ıf there is an amplitude on graphic the data will be assumed as stapes reflex positive.Change from Baseline in stapes muscle reflex at postoperative 1 day
Measured: postoperative 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; Adverse EffectStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Recep Aksu, TC Erciyes University
- Investigators
- Gunhan Gokahmetoglu, M.D, Principal investigator, M.D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062333
- Sponsor's protocol ID
- 2013/425
- Status last verified
- Nov 2014
- First submitted
- 6 Feb 2014
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea
- ClinicalTrials.gov ID
- NCT02062333
- Acronym / sponsor ID
- 2013/425
- Keywords
- dexmedetomidine, esmolol, stapes reflex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Feb 2014 (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.
The aim of this study is to find the Effects of Anesthetics Used in Hypotensive Anesthesia on Stapes Reflex and Distortion Product Auto Acoustic Emission.
Detailed description
This study was aimed at evaluating the effects of dexmedetomidine and esmolol on stapes reflex and distortion product auto acoustic emission. the stapes reflex and auto acoustic emission are of considerable diagnostic significances in otolaryngology this are objective methods for the assessment of auditory function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Active comparator | Drug: Dexmedetomidine0,4-0,8 µg./kg./h dexmedetomidine |
| esmolol | Active comparator | Drug: esmolol100- 300 µg./kg./min esmolol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 age
- American Society of Anaesthesiologists physical status classification (ASA)1-2
- tympanoplasty surgery
- patients with normal stapes reflexes
Key exclusion criteria (4 listed)
- hypertension
- drug allergy
- cardiac problems
- pregnancy
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 |
|---|---|---|
| DexmedetomidineAlso: precedex1 mcg/kg dexmedetomidine is applied bolus and 0.2 mcg/kg/h dexmedetomidine is applied iv infusion | Drug | dexmedetomidine |
| esmololAlso: breviblock500 mcg/kg brevibloc is applied bolus and 100 mcg/kg/h iv infusion | Drug | esmolol |
Primary outcome
distortion product auto acoustic emission
Time frame: postoperative 1 day
distortion product measurements will be performed in 1001, 1501, 2002, 3003, 4004, 6006, 7996 Hz frequencies and change from baseline in distortion product measurements at postoperative 1 day
1 secondary outcome
stapes reflex
Time frame: postoperative 1 day
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 10 Nov 2014.
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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.
Gunhan Gokahmetoglu, M.D principal investigator
M.D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and esmolol in people with Anesthesia; Adverse Effect and Reflex, Abnormal, run by TC Erciyes University 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 4 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 10 Nov 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
distortion product auto acoustic emission (time frame: postoperative 1 day). 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 10 Nov 2014.