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Completed

NCT Number: NCT02062333

The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kayseri Education and Research Hospital

Kayseri, 38039, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • hypertension
  • drug allergy
  • cardiac problems
  • pregnancy

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: precedex

esmolol

Drug

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

Other names: breviblock

Primary outcomes

  1. 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

Secondary outcomes

  1. stapes reflex

    Time frame: postoperative 1 day

    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

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 13, 2014
Registry last updated
Nov 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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