Unique ID issued by UMIN | UMIN000010607 |
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Receipt number | R000012401 |
Scientific Title | Effectiveness of dexmedetomidine in stabilization of hemodynamics in patients undergoing carotid endarterectomy |
Date of disclosure of the study information | 2013/04/28 |
Last modified on | 2019/03/21 05:15:42 |
Effectiveness of dexmedetomidine in stabilization of hemodynamics in patients undergoing carotid endarterectomy
Effectiveness of dexmedetomidine in stabilization of hemodynamics in patients undergoing carotid endarterectomy
Effectiveness of dexmedetomidine in stabilization of hemodynamics in patients undergoing carotid endarterectomy
Effectiveness of dexmedetomidine in stabilization of hemodynamics in patients undergoing carotid endarterectomy
Japan |
carotid artery stenosis
Surgery in general |
Others
NO
Carotid artery stenosis is a major risk factor for ischemic stroke. Carotid endarterectomy (CEA) has become a standard procedure to treat and prevent stroke in patients with severe atherosclerotic carotid artery stenosis [1]. In such patients, arterial blood pressure is often difficult to control and perioperative hemodynamic instability is associated with increased morbidity and mortality after CEA. Dexmedetomidine (Dex) is a selective a2 agonist with sedative, anxiolytic and analgesic properties but has no depressive effects on ventilation [2]. We performed a randomized double-blind placebo-control clinical trial to evaluate the effects of low-dose Dex on perioperative hemodynamic stability.
Efficacy
maximum doses of nicardipine
plasma catecholamine levels
sedation scores
time to extubation
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
2
Treatment
Medicine |
Administration of dexmedetomidine in patients undergoing carotid endarterectomy
Administration of 0.9% saline in patients undergoing carotid endarterectomy
40 | years-old | <= |
Not applicable |
Male and Female
patients undergoing carotid endarterectomy for carotid artery stenosis
Patients with
1. opioid administration within 24 hours
2. American Society of Anesthesiologists Physical status IV or V.
3. past history of abnormal reaction to general anesthetics and dexmedetomidine
40
1st name | Kazutoshi |
Middle name | |
Last name | Ikeshita |
Yao Tokushukai General Hospital
Department of Anesthesiology
5810011
l-17, Wakakusacho, Yao City, Osaka, 581-0011, Japan
+81-72-993-8501
seashogo@shirt.ocn.ne.jp
1st name | Shogo |
Middle name | |
Last name | sujikawa |
Yao Tokushukai General Hospital
Department of Anesthesiology
5810011
l-17, Wakakusacho, Yao City, Osaka, 581-0011, Japan
+81-72-993-8501
seashogo@shirt.ocn.ne.jp
Yao Tokushukai General Hospital
none
Other
Yao Tokushukai General Hospital Ethics Review Committee
l-17, Wakakusamachi, Yao City, Osaka, 581-0011, Japan
+81-72-993-8501
seashogo@shirt.ocn.ne.jp
NO
2013 | Year | 04 | Month | 28 | Day |
https://link.springer.com/article/10.1007/s00540-019-02612-w
Published
https://link.springer.com/article/10.1007/s00540-019-02612-w
50
The baseline clinical characteristics were similar in the two groups. The
maximum dose of nicardipine (p = 0.021), plasma norepinephrine level (p = 0.033),
sedation score and VAS were significantly lower in the Dex group than the control
group. There were no differences between the two groups regarding time to extubation,arterial blood gases, and adverse events.
2019 | Year | 03 | Month | 21 | Day |
After obtaining approval from the Yao Tokushukai General Hospital Ethics Review Committee (Registered number 24; July 2012) and written informed consent from the patients, we studied 50 patients with ASA physical status II or III who were scheduled for elective carotid endarterectomy between April 2013 and April 2015. This investigation was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000010607).
Data of 2 patients from the control group and 1 patient from the Dex group
were excluded from analysis due to missing data. Thus, the final analysis was based on data of 47 patients. There were no significant differences in demographic data between the groups
none
The primary outcome measure of this study was the maximum dose of nicardipine. The secondary outcome measures included the total dose of nicardipine for 180 min, time to extubation, plasma catecholamine levels, sedation scores, VAS scores, arterial blood gas analysis and adverse events.
Completed
2013 | Year | 04 | Month | 28 | Day |
2012 | Year | 07 | Month | 15 | Day |
2013 | Year | 04 | Month | 30 | Day |
2015 | Year | 06 | Month | 30 | Day |
2017 | Year | 04 | Month | 01 | Day |
2017 | Year | 04 | Month | 01 | Day |
2018 | Year | 01 | Month | 01 | Day |
2013 | Year | 04 | Month | 28 | Day |
2019 | Year | 03 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012401
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