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The Neuroprotection Effect of Dexmedetomidine

  • Clinicaltrials.gov identifier

    NCT03927963

  • Recruitment Status

    Not yet recruiting

  • First Posted

    April 25, 2019

  • Last update posted

    April 25, 2019

Study Description

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:Dexmedetomidine
  • Intervention/Treatment: Drug: Dexmedetomidine
    Drug: Propofol
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: September 2020
  • Estimated Study Completion Date: February 2021

Arms and interventions

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

Outcome Measures

  • 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 ]

Eligibility Criteria

  • Ages Eligible for Study: 19 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

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Ajou University School of Medicine

More Information

  • Responsible Party: Ajou University School of Medicine
  • ClinicalTrials.gov Identifier: NCT03927963 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No