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The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

NCT ID: NCT02062333

Last Updated: 2014-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexmedetomidine

0,4-0,8 µg./kg./h dexmedetomidine

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

1 mcg/kg dexmedetomidine is applied bolus and 0.2 mcg/kg/h dexmedetomidine is applied iv infusion

esmolol

100- 300 µg./kg./min esmolol

Group Type ACTIVE_COMPARATOR

esmolol

Intervention Type DRUG

500 mcg/kg brevibloc is applied bolus and 100 mcg/kg/h iv infusion

Interventions

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Dexmedetomidine

1 mcg/kg dexmedetomidine is applied bolus and 0.2 mcg/kg/h dexmedetomidine is applied iv infusion

Intervention Type DRUG

esmolol

500 mcg/kg brevibloc is applied bolus and 100 mcg/kg/h iv infusion

Intervention Type DRUG

Other Intervention Names

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precedex breviblock

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Recep Aksu

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gunhan Gokahmetoglu, M.D

Role: PRINCIPAL_INVESTIGATOR

M.D

Locations

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Kayseri Education and Research Hospital

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2013/425

Identifier Type: -

Identifier Source: org_study_id