UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024628
Receipt number R000028215
Scientific Title The effect of intravenous Ketamine for vesical tenesmus after transuretheral surgery
Date of disclosure of the study information 2016/10/31
Last modified on 2020/05/12 16:17:09

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Basic information

Public title

The effect of intravenous Ketamine for vesical tenesmus after transuretheral surgery

Acronym

The effect of Ketamine for vesical tenesmus

Scientific Title

The effect of intravenous Ketamine for vesical tenesmus after transuretheral surgery

Scientific Title:Acronym

The effect of Ketamine for vesical tenesmus

Region

Japan


Condition

Condition

Transuretheral surgery as follows.

TUR-Bt, TUL, TUR-P, HoLEP

Classification by specialty

Anesthesiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluating the efficacy of the intravenous Ketamine for vesical tenesmus after the transuretheral surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Assessment of post-operative viscical tenesmus by using tenesmus score.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Allocate the patients in each operation to Ketamine group and Control group. In the Ketamine group, Ketamine 0.25 mg/kg is administrated intravenously before the surgery.

Interventions/Control_2

Allocate the patients in each operation to Ketamine group and Control group.
In the Control group, patients is managed by usual anesthetic management.

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

80 years-old >=

Gender

Male

Key inclusion criteria

1) Adult male patients whose age are between 20 and 80 years old.
2) Patients undergoing transuretheral surgery.

Key exclusion criteria

1) Patients suffering cerebrovascular disease,hypertension; systolic blood pressure over 160mmHg/ diastolic blood pressure over 100mmHg,hyper high intracranial pressure,and severe heart failure.
2) Past medical history of convulsion.
3) BMI over 35
4) Other patients judged as inadequate by the principal investigator.

Target sample size

96


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoko Mae

Organization

Tokyo Metropolitan Police Hospital

Division name

Department of Anesthesiology

Zip code


Address

4-22-1 Nakano, Nakano-ku,Tokyo,Japan

TEL

03-5343-5611

Email

chikomae@sa2.so-net.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoko Mae

Organization

Tokyo Metropolitan Police Hospital

Division name

Department of Anesthesiology

Zip code


Address

4-22-1 Nakano, Nakano-ku,Tokyo,Japan

TEL

03-5343-5611

Homepage URL


Email

chikomae@sa2.so-net.ne.jp


Sponsor or person

Institute

Tokyo Metropolitan Police Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 31 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

47

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

2016 Year 10 Month 12 Day

Date of IRB

2016 Year 10 Month 12 Day

Anticipated trial start date

2016 Year 11 Month 01 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 29 Day

Last modified on

2020 Year 05 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028215


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name