UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of crystalloid and colloid in CO-loading to prevent hypotension during anesthesia induction
Title of the study (Brief title)	Effects of crystalloid and colloid in CO-loading to prevent hypotension during anesthesia induction
Region	Japan

Condition
Condition	Patients undergoing laparoscopic surgery under genera anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of crystalloid and colloid in CO-loading to prevent hypotension during anesthesia induction
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of hypotension during anesthesia induction
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Prevention
Type of intervention	Medicine
Interventions/Control_1	In the intervention group patients, colloid is used for volume expansion during anesthesia induction.
Interventions/Control_2	In the intervention group patients, crystalloid is used for volume expansion during anesthesia induction.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing laparoscopic surgery under general anesthesia
Key exclusion criteria	1) Atrial fibrillation 2) Decreased cardiac function (Ejection Fraction <50%) 3) Decreased renal function (Serum Cre >2.0mg/dl) 4) Hypernatremia (Serum Na >155mEq/L) or hyperchloremia (Serum Cl>120mEq/L) 5) Intracranial hemorrhage
Target sample size	90

Research contact person
Name of lead principal investigator	Koichi Suehiro
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Anesthesiology
Address	1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL	06-6645-2186
Email	suehirokoichi@yahoo.co.jp

Public contact
Name of contact person	Koichi Suehiro
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Anesthesiology
Address	1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL	06-6645-2186
Homepage URL
Email	suehirokoichi@yahoo.co.jp

Sponsor
Institute	Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Anesthesiology, Osaka City University Graduate School of Medicine
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 08 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 30 Day
Anticipated trial start date	2015 Year 08 Month 10 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 08 Month 18 Day
Last modified on	2016 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021548