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CompletedNCT02062333Updated Nov 10, 2014

The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

A Phase 4 interventional study of Dexmedetomidine and esmolol in Anesthesia; Adverse Effect, Reflex, Abnormal and Tinnitus, Spontaneous Oto-Acoustic Emission, sponsored by TC Erciyes University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-11-10.

Sponsored by TC Erciyes University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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 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.

02

Conditions studied

  • Anesthesia; Adverse Effect
  • Reflex, Abnormal
  • Tinnitus, Spontaneous Oto-Acoustic Emission

Keywords

  • dexmedetomidine
  • esmolol
  • stapes reflex
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In context

Reflex, Abnormal

21 studies on the registry are indexed under Reflex, Abnormal; 1 is open to participants now.

This study's enrollment of 47 is above the median of 25 across 15 interventional studies indexed under Reflex, Abnormal.

Browse Reflex, Abnormal studies →

Lead sponsor

TC Erciyes University is the lead sponsor of 346 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18-65 age
  • American Society of Anaesthesiologists physical status classification (ASA)1-2
  • tympanoplasty surgery
  • patients with normal stapes reflexes

Exclusion criteria

Exclusion Criteria:

  • hypertension
  • drug allergy
  • cardiac problems
  • pregnancy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
47 participants (actual)

Study arms

  • Active comparator
    dexmedetomidine

    0,4-0,8 µg./kg./h dexmedetomidine

    Drug: Dexmedetomidine

  • Active comparator
    esmolol

    100- 300 µg./kg./min esmolol

    Drug: esmolol

Interventions

  • 1 mcg/kg dexmedetomidine is applied bolus and 0.2 mcg/kg/h dexmedetomidine is applied iv infusion

    Also known as: precedex

  • 500 mcg/kg brevibloc is applied bolus and 100 mcg/kg/h iv infusion

    Also known as: breviblock

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: postoperative 1 day

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Study locations

1 site
  • Kayseri Education and Research Hospital
    Kayseri, 38039, Turkey (Türkiye)
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02062333
Responsible party
Recep Aksu (associate professor, TC Erciyes University) — Principal investigator
First posted
Feb 13, 2014
Start date
Jan 2014
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Nov 10, 2014

Study contacts

Gunhan Gokahmetoglu, M.D
principal investigator · M.D

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Dexmedetomidine · Esmolol

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