UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Significant decreases in blood propofol concentrations during adrenalectomy for phaeochromocytoma
Title of the study (Brief title)	Significant decreases in blood propofol concentrations during adrenalectomy for phaeochromocytoma
Region	Japan

Condition
Condition	pheochromocytoma
Classification by specialty	Endocrine surgery Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the relationship between hemodynamic changes and propofol blood concentration during propofol anesthesia for pheochromocytoma surgery
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of propofol blood concentration
Key secondary outcomes	Change of hepatic blood flow Change of bispectral index

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patient underwent unilateral adrenalectomy for pheochromocytoma
Key exclusion criteria	Central nervous system diseases prior to surgery Allergy of propofol,soybeans and albumen Disease which reduces reliability of the Flowtrack Reduced cardiac function Not obtained the informed consent Administration of albumin by the bleeding during surgery
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroshi Baba
Organization	Niigata University
Division name	Department of Anesthesiology
Address	1-757 Asahimachi, Chuo-ku, Niigata
TEL	025-227-2328
Email	baba@med.niigata-u.ac.jp

Public contact
Name of contact person	Tatsunori Watanabe
Organization	Niigata University
Division name	Department of Anesthesiology
Address	1-757 Asahimachi, Chuo-ku, Niigata
TEL	025-227-2328
Homepage URL
Email	t-wata@med.niigata-u.ac.jp

Sponsor
Institute	Department of Anesthesiology Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization	Niigata Medical Association
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Clinical Pharmacology, Gunma University Graduate School of Medicine
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	2012 Year 08 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 05 Day
Anticipated trial start date	2012 Year 03 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	Published
URL releasing results
Results
Other related information	To examine the relationship between hemodynamic changes and bispectral index during propofol anesthesia for pheochromocytoma surgery

Management information
Registered date	2012 Year 08 Month 20 Day
Last modified on	2018 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010100