UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Alteration of intraocular pressure in patients who underwent robot-assisted laparoscopic prostatectomies (RALPs)
Title of the study (Brief title)	Alteration of intraocular pressure in patients who underwent robot-assisted laparoscopic prostatectomies (RALPs)
Region	Japan

Condition
Condition	prostatic carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We would like to know grade of elevation of ocular pressure during surgery
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	measurement of intraocular pressure by an anesthesiologist during surgery
Key secondary outcomes	duration of operation duration of prone position Used amount of atropine and vasopressor drugs blood pressure Bleeding volume Infusion volume

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	100 years-old >=
Gender	Male
Key inclusion criteria	Measurement of intraocular pressure is thought to be safety as ophthalmologist.
Key exclusion criteria	ophthalmologist judge the risk of estimation of intraocular pressure, for example, eyeground abnormality
Target sample size	30

Research contact person
Name of lead principal investigator	Tamie Takenami
Organization	Kitasato University School of Medicine
Division name	Anesthesiology
Address	1-15-1 Kitasato, Sagamihara, Minami-ku
TEL	042-778-8111
Email	takenami@med.kitazato-u.ac.jp

Public contact
Name of contact person	Tamie Takenami
Organization	Kitasato University School of Medicine
Division name	Anesthesiology
Address	1-15-1 Kitasato, Sagamihara, Minami-ku
TEL	042-778-8111
Homepage URL
Email	takenami@med.kitazato-u.ac.jp

Sponsor
Institute	Department of Aensthesiology, Kitasato Univrtsity School of Medicine
Institute
Department

Funding Source
Organization	Kitasato Univrtsity Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2017 Year 02 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 25 Day
Anticipated trial start date	2016 Year 03 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We don't use any drug except usual anesthetic drugs Twice estimation of intraocular pressure with Tonopen by ophthalmologist on the day before surgery. Ten times estimation of intraocular pressure with Tonopen by anestheologist on the day of surgery.

Management information
Registered date	2016 Year 12 Month 28 Day
Last modified on	2016 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029085