Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution

Yonsei University

Status: Completed

Conditions: Craniotomy

Treatments: Drug: scalp infiltration solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01606969

4-2012-0062

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Dex group

Experimental group

Description:

dexmedetomidine-lidocaine solution,

Treatment:

Drug: scalp infiltration solution

Drug: scalp infiltration solution

Control group

Active Comparator group

Description:

epinephrine-lidocaine solution

Treatment:

Drug: scalp infiltration solution

Drug: scalp infiltration solution