The Neuroprotection Effect of Dexmedetomidine

NCT ID: NCT03927963

Last Updated: 2019-04-25

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-02-28

Brief Summary

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The brain protection effect of dexmedetomidine has been approved in several studies.

Basically, the anti-inflammatory effects and reducing catecholamines are thought to be a main role of the protection effect. In many studies reported the advantage of dexmedetomidine as a substitution of other sedative drugs for anesthesia.

The anesthesia of intra-cranial aneurysmal clipping operation commonly use intravenous anesthetic agents combined with inhalation anesthesia for neuroprotection, and mostly propofol is used.

The aim of this study is to examine the effects of dexmedetomidine on serum inflammatory markers and research the hemodynamic stability of dexmedetomidine compared to propofol in aneurysmal clipping operation.

Detailed Description

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Conditions

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Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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propofol

Group Type PLACEBO_COMPARATOR

Propofol

Intervention Type DRUG

Effect site concentration of propofol 1.5 ng/ml with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period

dexmedetomidine

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine 0.7 ug/kg/h with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period

Interventions

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Dexmedetomidine

Dexmedetomidine 0.7 ug/kg/h with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period

Intervention Type DRUG

Propofol

Effect site concentration of propofol 1.5 ng/ml with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA class I,II patient needs operation of intracranial aneurysmal clipping without SAH

Exclusion Criteria

* Any history of neurologic disease, dementia
* Allergic history of propofol or dexmedetomidine
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jiyoung Yoo

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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AJIRB-MED-OBS-18-478

Identifier Type: -

Identifier Source: org_study_id

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