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Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution

This study is not yet open for participant recruitment.
Verified May 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01606969
First received: May 20, 2012
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Craniotomy
 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:

U.S. FDA Resources

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)


Estimated Enrollment: 54
Study Start Date: June 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 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)

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606969

Contacts
Contact: Kyeong Tae Min, MD 82-2-2228-2417 ktmin501@yuhs.ac

Locations
Korea, Republic of
Severance hospital Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: Kyeong Tae Min, MD     82-2-2228-2714     kimin501@yuhs.ac    
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01606969     History of Changes
Other Study ID Numbers: 4-2012-0062
Study First Received: May 20, 2012
Last Updated: May 25, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
Dexmedetomidine
epinephrine
lidocaine
scalp infiltration
craniotomy

Additional relevant MeSH terms:
Epinephrine
Dexmedetomidine
Epinephryl borate
Lidocaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
 Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on June 17, 2013