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NCT02062333 Clinical Trial

The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

Anesthesia; Adverse Effect Clinical Trial

Official title:
The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02062333
Other study ID # 2013/425
Secondary ID
Status Completed
Phase Phase 4
First received February 6, 2014
Last updated November 7, 2014
Start date January 2014
Est. completion date November 2014

Study information
Verified date November 2014
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine
1 mcg/kg dexmedetomidine is applied bolus and 0.2 mcg/kg/h dexmedetomidine is applied iv infusion
• esmolol
500 mcg/kg brevibloc is applied bolus and 100 mcg/kg/h iv infusion

Locations
Country Name City State
Turkey Kayseri Education and Research Hospital Kayseri

Sponsors (1)
Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 postoperative 1 day No
Secondary stapes reflex stapes muscle reflex measurements will be performed by electrical impedance. data will be taken as graphics. if 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 No
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