The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

Phase 4

Completed

• Conditions: Tinnitus, Spontaneous Oto-Acoustic Emission; Reflex, Abnormal; Anesthesia; Adverse Effect
• Interventions: Drug: esmolol; Drug: Dexmedetomidine

• Registration Number: NCT02062333
• Lead Sponsor: TC Erciyes University

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-13
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-07
• Last Update Posted: 2014-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
esmolol	esmolol	100- 300 µg./kg./min esmolol
dexmedetomidine	Dexmedetomidine	0,4-0,8 µg./kg./h dexmedetomidine

Primary Outcome Measures

Name	Time	Method
distortion product auto acoustic emission	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 Outcome Measures

Name	Time	Method
stapes reflex	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

Trial Locations

Locations (1)

Kayseri Education and Research Hospital; 🇹🇷 Kayseri, Turkey