UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of dose differences of remifentanil to functions of endocrine system in perioperative patients
Title of the study (Brief title)	The influence of dose differences of remifentanil to functions of endocrine system in perioperative patients
Region	Japan

Condition
Condition	Perioperative adult patients undergoing orthopedic surgery
Classification by specialty	Endocrinology and Metabolism Orthopedics Anesthesiology Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the influence of intraoperative variations of administration rate of remifentanil to functions of endocrine system in perioperative adult patients
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	renin, aldosterone, cortisol
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Remifentanil 1 microgram/kg/min
Interventions/Control_2	Remifentanil 0.5 microgram/kg/min
Interventions/Control_3	Remifentanil 0.25 microgram/kg/min
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	Not applicable
Gender	Female
Key inclusion criteria	Perioperative adult patients undergoing total hip arthroplasty(THA)
Key exclusion criteria	Patients with preoperative heart failure, severe valvular disease, not sinus rhythm and obesity(BMI>=30)
Target sample size	60

Research contact person
Name of lead principal investigator	Takerou Terashi
Organization	Kagoshima Red Cross Hospital
Division name	Department of anesthesiology
Address	2545 Hirakawa-cho, Kagoshima City, Kagoshima 891-0133, Japan
TEL	099-261-2111
Email	terashi@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Takerou Terashi
Organization	Kagoshima Red Cross Hospital
Division name	Department of anesthesiology
Address	2545 Hirakawa-cho, Kagoshima City, Kagoshima 891-0133, Japan
TEL	099-261-2111
Homepage URL
Email	terashi@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima Red Cross Hospital
Institute
Department

Funding Source
Organization	Kagoshima Red Cross Hospital
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	鹿児島赤十字病院（鹿児島県）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 02 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 02 Month 01 Day
Anticipated trial start date	2014 Year 02 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	2014 Year 04 Month 02 Day
Last modified on	2017 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015508