The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02062333

Enrollment

Registered

2014-02-13

Start date

2014-01-31

Completion date

2014-11-30

Last updated

2014-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

dexmedetomidine, esmolol, stapes reflex

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.

Interventions

DRUGDexmedetomidine

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

DRUGesmolol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026