Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution

This study has been completed.
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: May 20, 2012
Last updated: March 4, 2014
Last verified: March 2014

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.

Condition Intervention
Drug: scalp infiltration solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial to Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution for the Effect on Hemodynamic Response Due to Scalp Infiltration in Patients Undergoing Craniotomy

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Mean arterial pressure [ Time Frame: before and after scalp injection ] [ Designated as safety issue: No ]
    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)

Enrollment: 48
Study Start Date: June 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dex group
dexmedetomidine-lidocaine solution,
Drug: scalp infiltration solution
Dex group: Dexmedetomidine 2mcg/ml-containing 2% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)
Active Comparator: Control group
epinephrine-lidocaine solution
Drug: scalp infiltration solution
1:200000 epinephrine-containing 2% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)


Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01606969

Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University Identifier: NCT01606969     History of Changes
Other Study ID Numbers: 4-2012-0062 
Study First Received: May 20, 2012
Last Updated: March 4, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
scalp infiltration

Additional relevant MeSH terms:
Epinephryl borate
Pharmaceutical Solutions
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Analgesics, Non-Narcotic
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Sodium Channel Blockers processed this record on May 26, 2016