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The Neuroprotection Effect of Dexmedetomidine

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927963
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Jiyoung Yoo, Ajou University School of Medicine

Brief Summary:

The brain protection effect of dexmedetomidine has been approved in several studies.

Basically, the anti-inflammatory effects and reducing catecholamines are thought to be a main role of the protection effect. In many studies reported the advantage of dexmedetomidine as a substitution of other sedative drugs for anesthesia.

The anesthesia of intra-cranial aneurysmal clipping operation commonly use intravenous anesthetic agents combined with inhalation anesthesia for neuroprotection, and mostly propofol is used.

The aim of this study is to examine the effects of dexmedetomidine on serum inflammatory markers and research the hemodynamic stability of dexmedetomidine compared to propofol in aneurysmal clipping operation.


Condition or disease Intervention/treatment Phase
Dexmedetomidine Drug: Dexmedetomidine Drug: Propofol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Anti-inflammatory Effect and Hemodynamic Stability of Dexmedetomidine in Aneurysmal Clipping Operation; Compare With Propofol
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: propofol Drug: Propofol
Effect site concentration of propofol 1.5 ng/ml with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period

Active Comparator: dexmedetomidine Drug: Dexmedetomidine
Dexmedetomidine 0.7 ug/kg/h with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period




Primary Outcome Measures :
  1. The concentration of inflammatory markers [ Time Frame: Baseline: Before injection study drugs ]
    CRP (mg/ml)

  2. The concentration of inflammatory markers [ Time Frame: 1 minute after operation ]
    CRP (mg/ml)

  3. The concentration of inflammatory markers [ Time Frame: Day 1 after operation ]
    CRP (mg/ml)

  4. The concentration of inflammatory markers [ Time Frame: Day 2 after operation ]
    CRP (mg/ml)

  5. The concentration of norepinephrine [ Time Frame: Baseline: Before injection study drugs ]
    NE (nmol/l)

  6. The concentration of norepinephrine [ Time Frame: 1 minute after operation ]
    NE (nmol/l)

  7. The concentration of norepinephrine [ Time Frame: Day 1 after operation ]
    NE (nmol/l)

  8. The concentration of norepinephrine [ Time Frame: Day 2 after operation ]
    NE (nmol/l)

  9. The concentration of inflammatory markers [ Time Frame: Baseline: Before injection study drugs ]
    IL-6, IL-8, IL-10 ,TNF-a (pg/ml)

  10. The concentration of inflammatory markers [ Time Frame: 1 minute after operation ]
    IL-6, IL-8, IL-10 ,TNF-a (pg/ml)

  11. The concentration of inflammatory markers [ Time Frame: Day 1 after operation ]
    IL-6, IL-8, IL-10 ,TNF-a (pg/ml)

  12. The concentration of inflammatory markers [ Time Frame: Day 2 after operation ]
    IL-6, IL-8, IL-10 ,TNF-a (pg/ml)


Secondary Outcome Measures :
  1. The frequency of hypotension or hypertension [ Time Frame: during operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA class I,II patient needs operation of intracranial aneurysmal clipping without SAH

Exclusion Criteria:

  • Any history of neurologic disease, dementia
  • Allergic history of propofol or dexmedetomidine
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Responsible Party: Jiyoung Yoo, Assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03927963    
Other Study ID Numbers: AJIRB-MED-OBS-18-478
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action