UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison ofcontinuous epidural infusion(CEI) and programmed intermittent epidural bolus (PIEB) in open abdominal surgery.
Title of the study (Brief title)	Comparison of CEI and PIEB.
Region	Japan

Condition
Condition	Patients undergoing open abdominal surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The intermittent administration of the agent to the epidural space is compared with the continuous administration, the diffusion of the drug is large, it has been efficiently reported the analgesic effect is obtained at lower doses. We compared a method of continuous epidural infusion with programmed intermittent epidural bolus, and evaluated the efficacy of postoperative epidural analgesia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	anesthesia level, visual analog scale, postoperative medication
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved 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	we administered analgesic agents by programmed intermitttent epidural bolus for patient undergoing open abdominal surgery.
Interventions/Control_2	we administered analgesic agents by continuous epidural infusion for patient undergoing open abdominal surgery.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	American Society of Anesthesiologists Physical States of I - III. the ages over 20 years old. Patients undergoing open abdominal surgery.
Key exclusion criteria	American Society of Anesthesiologists Physical States over IV. under 20 years old. Patients who do not obtain consent.
Target sample size	60

Research contact person
Name of lead principal investigator	Yasuo Tsutsumi
Organization	Tokushima University Graduate School
Division name	Department of Anesthesiology
Address	3-18-15 Kuramoto, Tokushima
TEL	088-633-7181
Email	tsutsumi@tokushima-u.ac.jp

Public contact
Name of contact person	Nami Kakuta
Organization	Tokushima University Graduate School
Division name	Department of Anesthesiology
Address	3-18-15 Kuramoto, Tokushima
TEL	088-633-7181
Homepage URL
Email	kakuta.nami@tokushima-u.ac.jp

Sponsor
Institute	Institute of Biomedical Sciences Tokushima University Graduate School, Department of Anesthesiology
Institute
Department

Funding Source
Organization	departmental funding
Organization
Division
Category of Funding Organization	Other
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 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 25 Day
Anticipated trial start date	2016 Year 04 Month 01 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

Management information
Registered date	2015 Year 09 Month 01 Day
Last modified on	2018 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021840