Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution

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

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-05-31

Brief Summary

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Scalp infiltration with Epinephrine- containing lidocaine solution is common method for craniotomy but it may result in transient but significant hypotension in patients undergoing neurosurgery. Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response, and dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus theologically appropriate for reducing bleeding during scalp incision in craniotomy.

The aim of this study is to compare the effect of dexmedetomidine-lidocaine solution on hemodynamic response, scalp bleeding to epinephrine-lidocaine solution.

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Detailed Description

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Conditions

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Craniotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Dex group

dexmedetomidine-lidocaine solution,

Group Type EXPERIMENTAL

scalp infiltration solution

Intervention Type DRUG

Dex group: Dexmedetomidine 2mcg/ml-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)

Control group

epinephrine-lidocaine solution

Group Type ACTIVE_COMPARATOR

scalp infiltration solution

Intervention Type DRUG

1:100000 epinephrine-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)

Interventions

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scalp infiltration solution

Dex group: Dexmedetomidine 2mcg/ml-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)

Intervention Type DRUG

scalp infiltration solution

1:100000 epinephrine-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA I-II
* Aged between 20 and 70 year
* general anesthesia for craniotomy

Exclusion Criteria

* Congestive heart failure, coronary artery occlusive disease
* Bradycardia \< 50 BPM, 2nd degree \< AV block
* Poorly controlled hypertension
* ß blocker medication
* Coagulopathy
* Pregnancy, nursing

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No