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Dexmedetomidine in Spinal Anesthesia

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: NCT02155010
Recruitment Status : Completed
First Posted : June 4, 2014
Results First Posted : September 26, 2016
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Ki Hwa Lee, Inje University

Study Description
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Brief Summary:

Patients were randomized into two groups, A group and B group. A group and B group patients are injected intravenous dexmedetomidine after intrathecal injection (IT) of heavy bupivacaine and injected intravenous dexmedetomidine before IT of heavy bupivacaine, respectively.

The investigators will compare of hemodynamics and patient's comfortability between two groups.


Condition or disease Intervention/treatment Phase
Blood Pressure Anxiety Drug: Dexmedetomidine Drug: Dexmedetomidine with heavy bupivacaine Not Applicable

Detailed Description:
A and B group patients will intravenous inject dexmedetomidine 1mcg/kg for 10 minute loading infusion and 0.2mcg/kg/hr for continuous infusion. A group receive intravenous dexmedetomidine after procedure, and B group receive intravenous dexmedetomidine before procedure. Both group patients will hydrate 6 ml/kg crystalloid solution and will evaluated patient's anxiety and comfortability perioperative period. Vital signs will record 5 minutes interval at operating room and post-anesthetic care units.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Hemodynamic Effect of Dexmedetomidine on Heavy Bupivacaine Spinal Anesthesia
Study Start Date : March 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dexmedetomidine
IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
 Drug: Dexmedetomidine
Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
Other Name: Precedex
Active Comparator: Dexmedetomidine with heavy bupivacaine
IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine
 Drug: Dexmedetomidine with heavy bupivacaine
Dexmedetomidine infusion after IT of heavy bupivacaine
Other Names:
  • Precedex
  • Marcaine


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Hypotension [ Time Frame: up to 3 hours ]
    We compare incidence rate of hypotension during infusion of dexmedetomidine


Secondary Outcome Measures :
  1. Patient's Anxiety [ Time Frame: up to 3 days ]
    We compared patient's anxiety using spielberger's state-trait anxiety inventory before and after surgery. This consists of two self-evaluation scales designed to assess state-anxiety and trait-anxiety. Each scale contains 20 items, each of which is rated from 1 to 4. Clinically significant levels of state or trait-anxiety were defined as scores >50 on the state- or trait-anxiety scale. State or trait-anxiety inventory's minimal score is 20 and maximal score is 80. We analyzed State Anxiety Inventory scale before and after surgery.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20 - 60 aged patients
  • orthopedic operation undergoing spinal anesthesia

Exclusion Criteria:

  • more than American society of anesthesiologists classification 3
  • hypertension
  • diabetes mellitus
  • heart disease (bradycardia, atrioventricular block)
Contacts and Locations
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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): NCT02155010


Locations
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Korea, Republic of
Inje University, Haeundae paik hospital
Busan, Korea, Republic of, 612-896
Sponsors and Collaborators
Inje University
Investigators
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Principal Investigator: Ki Hwa Lee, MD Inje University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ki Hwa Lee, Assistant professor, Inje University
ClinicalTrials.gov Identifier: NCT02155010    
Other Study ID Numbers: 2014-003
First Posted: June 4, 2014    Key Record Dates
Results First Posted: September 26, 2016
Last Update Posted: September 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available within 3 years of study completion.
Keywords provided by Ki Hwa Lee, Inje University:
Dexmedetomidine
Spinal anesthesia
Additional relevant MeSH terms:
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Dexmedetomidine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
 Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action