The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

November 7, 2014 updated by: Recep Aksu, TC Erciyes University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38039
        • Kayseri Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dexmedetomidine
0,4-0,8 µg./kg./h dexmedetomidine
Drug: Dexmedetomidine
1 mcg/kg dexmedetomidine is applied bolus and 0.2 mcg/kg/h dexmedetomidine is applied iv infusion
Other Names:
  • precedex
Active Comparator: esmolol
100- 300 µg./kg./min esmolol
Drug: esmolol
500 mcg/kg brevibloc is applied bolus and 100 mcg/kg/h iv infusion
Other Names:
  • breviblock

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
postoperative 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
postoperative 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: Gunhan Gokahmetoglu, M.D, M.D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 6, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Estimate)

November 10, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/425

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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