UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014576
Receipt number R000016767
Scientific Title Antitussive effect of dexmedetomidine during surgery under spinal anesthesia
Date of disclosure of the study information 2014/07/17
Last modified on 2017/07/18 11:33:11

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Basic information

Public title

Antitussive effect of dexmedetomidine during surgery under spinal anesthesia

Acronym

Antitussive effect of dexmedetomidine

Scientific Title

Antitussive effect of dexmedetomidine during surgery under spinal anesthesia

Scientific Title:Acronym

Antitussive effect of dexmedetomidine

Region

Japan


Condition

Condition

Diseases requiring surgery under spinal anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To show antitussive effect of dexmedetomidine during surgery under spinal anesthesia in comparison with midazolam

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Presence and strength of the cough during surgery under spinal anesthesia with sedation

Key secondary outcomes

Perfusion index during surgery under spinal anesthesia with sedation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Dexmedetomidine

Interventions/Control_2

Midazolam

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing elective surgery with spinal anesthesia

Key exclusion criteria

1. Patients who are unable to provide effective informed consent because of diturbance of consciousness, dementia, etc
2. Patients who do not hope for sedation
3. Patients who are unable to communicate definitely because of diturbance of consciousness, dementia, etc
4. Patients with severe cardiopulmonary diseases
5. Patients with diseases which produce coughing such as bronchial asthma and chronic obstructive pulmonary disease
6. Patients at risk for aspiration
7. Patients who are contraindicated or inappropriate for spinal anesthesia
8. Operative methods which are contraindicated or inappropriate for spinal anesthesia
9. Operative methods that intraoperative coughing may produce serious injury
10. Operative methods that sedation is undesirable

Target sample size

44


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takayuki Sugano

Organization

Toho University

Division name

Department of Anesthesiology

Zip code


Address

564-1, Shimoshizu, Sakura, Chiba, Japan

TEL

043-462-8811

Email

t-sugano@sakura.med.toho-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takayuki Sugano

Organization

Toho university

Division name

Department of Anesthesiology

Zip code


Address

564-1, Shimoshizu, Sakura, Chiba, Japan

TEL

043-462-8811

Homepage URL


Email

t-sugano@sakura.med.toho-u.ac.jp


Sponsor or person

Institute

Toho university

Institute

Department

Personal name



Funding Source

Organization

Toho university

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


Address


Tel


Email



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

東邦大学医療センター佐倉病院(千葉県)


Other administrative information

Date of disclosure of the study information

2014 Year 07 Month 17 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2014 Year 04 Month 16 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 07 Month 16 Day

Last modified on

2017 Year 07 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016767


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name