UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of sedation on postoperative quality of recovery after transurethral surgery under spinal anesthesia in elderly patients
Title of the study (Brief title)	The effect of sedation on postoperative cognitive functional recovery after transurethral surgery under spinal anesthesia in elderly patients
Region	Japan

Condition
Condition	patients aged over 70 scheduled for transurethral resection of the bladder tumor under spinal anesthesia
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare the postoperative quality of recovery after transurethral resection of the bladder tumor under spinal anesthesia with awake or propofol sedation in elderly patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of recovery associated with six domains (physiologic, nociceptive, emotive, activities of daily living (ADL), cognitive, and overall patient perspective) of PQRS(Postoperative Quality of Recovery scale) at 3hours after surgery, the first, and the third postoperative day
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	awake group
Interventions/Control_2	sedation with propofol group
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients aged over 70 scheduled for transurethral resection of the bladder tumor
Key exclusion criteria	contraindication for spinal anesthesia
Target sample size	40

Research contact person
Name of lead principal investigator	Kikuko Suga
Organization	Kawasaki Municipal Hospital
Division name	Anesthesiology
Address	12-1 Shinkawadori Kawasaki-ku Kawasaki-shi Kanagawa-ken
TEL	044-233-5521
Email	kikuko.suga@gmail.com

Public contact
Name of contact person	Kikuko Suga
Organization	Kawasaki Municipal Hospital
Division name	Anesthesiology
Address	12-1 Shinkawadori Kawasaki-ku Kawasaki-shi Kanagawa-ken
TEL	044-233-5521
Homepage URL
Email	kikuko.suga@gmail.com

Sponsor
Institute	Kawasaki Municipal 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)

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	2015 Year 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 19 Day
Anticipated trial start date	2014 Year 01 Month 22 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 09 Day
Last modified on	2017 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019138