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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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1 March 2021 |
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Main ID: |
ChiCTR-IPR-15006372 |
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Date of registration:
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2015-05-10 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The effect of intraoperative dexmedetomidine on renal function after endovascular aneurysm repair operation in stanford type B aortic dissection patients: a randomized, double-blind, controlled trial
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Scientific title:
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The effect of intraoperative dexmedetomidine on renal function after endovascular aneurysm repair operation in stanford type B aortic dissection patients |
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Date of first enrolment:
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2016-12-01 |
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Target sample size:
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dexmedetomidine:51;Control:51; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=10918 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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4
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Countries of recruitment
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China
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Contacts
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Name:
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FuHai Ji
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Address:
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899 Pinghai Road, Suzhou, Jiangsu, China
215006
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Telephone:
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+86 13656207331 |
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Email:
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jifuhai@hotmail.com |
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Affiliation:
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The First Affiliated Hospital of Soochow University |
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Name:
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XiSheng Shan
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Address:
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899 Pinghai Road, Suzhou, Jiangsu, China
215006
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Telephone:
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+86 15895551822 |
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Email:
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xisheng83@sina.com |
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Affiliation:
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The First Affiliated Hospital of Soochow University |
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Key inclusion & exclusion criteria
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Inclusion criteria: The study included patients(aged >= 18 years), with American Society of Anesthesiologists (ASA) physical status II-III, who were diagnosed as stanford type B aortic dissection and scheduled to undergo selective endovascular aneurysm repair(EVAR) procedure.
Exclusion criteria: sick sinus syndrome, severe bradycardia (heart rate [HR] < 50 beats/min), left ventricular ejection fraction < 30% or heart failure, atrioventricular block, history of allergy to dexmedetomidine, lesion affecting the accessory renal artery or decline to sign the informed consent. Those patients in which surgical approach (EVAR) were switched to other surgical procedures such as vascular replacement surgery, were also excluded from the study.
Age minimum:
29
Age maximum:
83
Gender:
Both
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Health Condition(s) or Problem(s) studied
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stanford type B aortic dissection
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Intervention(s)
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dexmedetomidine:Intraoperative dexmedetomidine pump;Control:Intraoperative saline pump;
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Primary Outcome(s)
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acute kidney injury;
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Secondary Outcome(s)
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serum creatinine;estimated glomerular filtration rate;serum cystatin C;urine output;any postoperative complication;postoperative stroke;postoperative pneumonia;postoperative deep venous thrombosis;postoperative mesenteric venous thrombosis;postoperative cognitive dysfunction;length of ICU stay;length of hospital stay;
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Source(s) of Monetary Support
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National Natural Science Foundation of China (81671880), Natural Science Foundation of Jiangsu Province (BK20191171)
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Ethics review
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Status: Approved
Approval date: 09/04/2015
Contact:
sdfyec@126.com
Li Zhou
sdfyec@126.com
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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