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Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01606969
Recruitment Status : Completed
First Posted : May 28, 2012
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Craniotomy Drug: scalp infiltration solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : June 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013


Arm Intervention/treatment
Experimental: Dex group
dexmedetomidine-lidocaine solution,
Drug: scalp infiltration solution
Dex group: Dexmedetomidine 2mcg/ml-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)

Active Comparator: Control group
epinephrine-lidocaine solution
Drug: scalp infiltration solution
1:100000 epinephrine-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)




Primary Outcome Measures :
  1. Mean arterial pressure [ Time Frame: 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)



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606969


Locations
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Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01606969    
Other Study ID Numbers: 4-2012-0062
First Posted: May 28, 2012    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Keywords provided by Yonsei University:
Dexmedetomidine
epinephrine
lidocaine
scalp infiltration
craniotomy
Additional relevant MeSH terms:
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