UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000010607
Receipt No. 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 (Ver. 7)

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Basic information
Public title Effectiveness of dexmedetomidine in stabilization of hemodynamics in patients undergoing carotid endarterectomy
Acronym Effectiveness of dexmedetomidine in stabilization of hemodynamics in patients undergoing carotid endarterectomy
Scientific Title Effectiveness of dexmedetomidine in stabilization of hemodynamics in patients undergoing carotid endarterectomy
Scientific Title:Acronym Effectiveness of dexmedetomidine in stabilization of hemodynamics in patients undergoing carotid endarterectomy
Region
Japan

Condition
Condition carotid artery stenosis
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes maximum doses of nicardipine
Key secondary outcomes plasma catecholamine levels
sedation scores
time to extubation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of dexmedetomidine in patients undergoing carotid endarterectomy
Interventions/Control_2 Administration of 0.9% saline in patients undergoing carotid endarterectomy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients undergoing carotid endarterectomy for carotid artery stenosis
Key exclusion criteria 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
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name Kazutoshi
Middle name
Last name Ikeshita
Organization Yao Tokushukai General Hospital
Division name Department of Anesthesiology
Zip code 5810011
Address l-17, Wakakusacho, Yao City, Osaka, 581-0011, Japan
TEL +81-72-993-8501
Email seashogo@shirt.ocn.ne.jp

Public contact
1st name of contact person
1st name Shogo
Middle name
Last name sujikawa
Organization Yao Tokushukai General Hospital
Division name Department of Anesthesiology
Zip code 5810011
Address l-17, Wakakusacho, Yao City, Osaka, 581-0011, Japan
TEL +81-72-993-8501
Homepage URL
Email seashogo@shirt.ocn.ne.jp

Sponsor
Institute Yao Tokushukai General Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yao Tokushukai General Hospital Ethics Review Committee
Address l-17, Wakakusamachi, Yao City, Osaka, 581-0011, Japan
Tel +81-72-993-8501
Email seashogo@shirt.ocn.ne.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 28 Day

Related information
URL releasing protocol https://link.springer.com/article/10.1007/s00540-019-02612-w
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s00540-019-02612-w
Number of participants that the trial has enrolled 50
Results 
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.
Results date posted
2019 Year 03 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
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).
Participant flow 
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
Adverse events 
none
Outcome measures 
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.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 04 Month 28 Day
Date of IRB
2012 Year 07 Month 15 Day
Anticipated trial start date
2013 Year 04 Month 30 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
2017 Year 04 Month 01 Day
Date trial data considered complete
2017 Year 04 Month 01 Day
Date analysis concluded
2018 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 28 Day
Last modified on
2019 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012401