UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010607
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

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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

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

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 or person

Institute

Yao Tokushukai General Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012401


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name