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
About this trial
This is an interventional treatment trial for Anesthesia; Adverse Effect focused on measuring dexmedetomidine, esmolol, stapes reflex
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
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
NCT ID
NCT02062333
First Posted
February 6, 2014
Last Updated
November 7, 2014
Sponsor
TC Erciyes University
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
Learn more about this trial
The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea
We'll reach out to this number within 24 hrs