NCT02062333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

10 months

First QC Date

February 6, 2014

Last Update Submit

November 7, 2014

Conditions

Anesthesia; Adverse EffectReflex, AbnormalTinnitus, Spontaneous Oto-Acoustic Emission

Keywords

dexmedetomidineesmololstapes reflex

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • stapes reflex

    postoperative 1 day

Study Arms (2)

dexmedetomidine

ACTIVE COMPARATOR

0,4-0,8 µg./kg./h dexmedetomidine

Drug: Dexmedetomidine

esmolol

ACTIVE COMPARATOR

100- 300 µg./kg./min esmolol

Drug: esmolol

Interventions

DexmedetomidineDRUG

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

Also known as: precedex
dexmedetomidine
esmololDRUG

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

Also known as: breviblock
esmolol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age
  • American Society of Anaesthesiologists physical status classification (ASA)1-2
  • tympanoplasty surgery
  • patients with normal stapes reflexes

You may not qualify if:

  • hypertension
  • drug allergy
  • cardiac problems
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri Education and Research Hospital

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Reflex, AbnormalTinnitus

Interventions

Dexmedetomidineesmolol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gunhan Gokahmetoglu, M.D

    M.D

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 13, 2014

Study Start

January 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

TU(1)