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出境医 / 临床实验 / The Neuroprotection Effect of Dexmedetomidine
The Neuroprotection Effect of Dexmedetomidine
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 | Intervention/treatment | Phase |
|---|---|---|
| Dexmedetomidine | Drug: Dexmedetomidine Drug: Propofol | Not Applicable |
Study Design
| 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 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- The concentration of inflammatory markers [ Time Frame: Baseline: Before injection study drugs ]CRP (mg/ml)
- The concentration of inflammatory markers [ Time Frame: 1 minute after operation ]CRP (mg/ml)
- The concentration of inflammatory markers [ Time Frame: Day 1 after operation ]CRP (mg/ml)
- The concentration of inflammatory markers [ Time Frame: Day 2 after operation ]CRP (mg/ml)
- The concentration of norepinephrine [ Time Frame: Baseline: Before injection study drugs ]NE (nmol/l)
- The concentration of norepinephrine [ Time Frame: 1 minute after operation ]NE (nmol/l)
- The concentration of norepinephrine [ Time Frame: Day 1 after operation ]NE (nmol/l)
- The concentration of norepinephrine [ Time Frame: Day 2 after operation ]NE (nmol/l)
- The concentration of inflammatory markers [ Time Frame: Baseline: Before injection study drugs ]IL-6, IL-8, IL-10 ,TNF-a (pg/ml)
- The concentration of inflammatory markers [ Time Frame: 1 minute after operation ]IL-6, IL-8, IL-10 ,TNF-a (pg/ml)
- The concentration of inflammatory markers [ Time Frame: Day 1 after operation ]IL-6, IL-8, IL-10 ,TNF-a (pg/ml)
- The concentration of inflammatory markers [ Time Frame: Day 2 after operation ]IL-6, IL-8, IL-10 ,TNF-a (pg/ml)
Secondary Outcome Measures :
- The frequency of hypotension or hypertension [ Time Frame: during operation ]
Eligibility Criteria
| 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
Contacts and Locations
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | March 12, 2019 | ||||
| First Posted Date ICMJE | April 25, 2019 | ||||
| Last Update Posted Date | April 25, 2019 | ||||
| Estimated Study Start Date ICMJE | May 1, 2019 | ||||
| Estimated Primary Completion Date | September 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
The frequency of hypotension or hypertension [ Time Frame: during operation ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Neuroprotection Effect of Dexmedetomidine | ||||
| Official Title ICMJE | The Anti-inflammatory Effect and Hemodynamic Stability of Dexmedetomidine in Aneurysmal Clipping Operation; Compare With Propofol | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Other |
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| Condition ICMJE | Dexmedetomidine | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
70 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | February 28, 2021 | ||||
| Estimated Primary Completion Date | September 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 19 Years to 85 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03927963 | ||||
| Other Study ID Numbers ICMJE | AJIRB-MED-OBS-18-478 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Jiyoung Yoo, Ajou University School of Medicine | ||||
| Study Sponsor ICMJE | Ajou University School of Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Ajou University School of Medicine | ||||
| Verification Date | April 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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