Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution

Not Applicable

Completed

• Conditions: Craniotomy
• Interventions: Drug: scalp infiltration solution

• Registration Number: NCT01606969
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-20
• Study First Submitted QC: 2012-05-25
• Study First Posted: 2012-05-28
• Study Start: 2012-06
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dex group	scalp infiltration solution	dexmedetomidine-lidocaine solution,
Control group	scalp infiltration solution	epinephrine-lidocaine solution

Primary Outcome Measures

Name	Time	Method
Mean arterial pressure	before and after scalp injection	before scalp injection(T0), after scalp injection every half minute until five minutes(T0.5, T1, T1.5, T2, T2.5, T3, T3.5, T4, T4.5, T5), every minute(T6, T7, T8, T9, T10, T11, T12, T13, T14, T15)

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of