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The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dexmedetomidine
esmolol
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia; Adverse Effect focused on measuring dexmedetomidine, esmolol, stapes reflex

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kayseri Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

dexmedetomidine

esmolol

Arm Description

0,4-0,8 µg./kg./h dexmedetomidine

100- 300 µg./kg./min esmolol

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2014
Last Updated
November 7, 2014
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT02062333
Brief Title
The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea
Official Title
The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Adverse Effect, Reflex, Abnormal, Tinnitus, Spontaneous Oto-Acoustic Emission
Keywords
dexmedetomidine, esmolol, stapes reflex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine
Arm Type
Active Comparator
Arm Description
0,4-0,8 µg./kg./h dexmedetomidine
Arm Title
esmolol
Arm Type
Active Comparator
Arm Description
100- 300 µg./kg./min esmolol
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precedex
Intervention Description
1 mcg/kg dexmedetomidine is applied bolus and 0.2 mcg/kg/h dexmedetomidine is applied iv infusion
Intervention Type
Drug
Intervention Name(s)
esmolol
Other Intervention Name(s)
breviblock
Intervention Description
500 mcg/kg brevibloc is applied bolus and 100 mcg/kg/h iv infusion
Primary Outcome Measure Information:
Title
distortion product auto acoustic emission
Description
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 Outcome Measure Information:
Title
stapes reflex
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunhan Gokahmetoglu, M.D
Organizational Affiliation
M.D
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kayseri Education and Research Hospital
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

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The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

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