UMIN-CTR Clinical Trial

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
Institute	Tokyo Metropolitan Police Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028215