UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of perioperative propofol infusion on energy expenditure, fat metabolism, protein catabolism and clinical courses following esophageal cancer surgery
Title of the study (Brief title)	Comparison of two different anaesthesia/sedation techniques in esophageal cancer surgery : propofol anaesthesia/propofol sedation and sevoflurane anaesthesia/midazolam sedation
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastrointestinal surgery Anesthesiology Intensive care medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To Investigate the effects of perioperative propofol infusion on energy expenditure, fat metabolism, protein catabolism and clinical courses following esophageal cancer surgery
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome is set to demonstrate that propofol has significant effects on energy expenditure, fat metabolism and protein catabolism.
Key secondary outcomes	Secondary outcome includes improvement in postoperative clinical courses by propofol.

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	The patients are devided into two groups: propofol anaesthesia/propofol sedation group (Group PP, n = 10) or sevoflurane anaesthesia/midazolam sedation group (Group SM, n = 10). In Group PP, anaesthesia is induced with propofol and fentanyl, and maintained with propofol and fentanyl. Sedation is maintained with propofol.
Interventions/Control_2	In Group SM, anaesthesia is induced with thiamylal and fentanyl, and maintained with sevoflurane and fentanyl. Sedation is maintained with midazolam.
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	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male
Key inclusion criteria	Male patients who undergo elective thoracoabdominal esophagectomy with gastric tube reconstruction starting at 9:00 a.m. and had performance status 0 are entered .
Key exclusion criteria	Preoperative exclusion criteria includes the patients who are obese (Body Mass Index > 30), have histories of diabetic mellitus, hyperlipidemia, liver dysfunction, renal dysfunction(Cr > 1.0), high-calorie infusion administration or chemoradiotherapy within 1 month before the day of surgery, or take medications of beta-adrenergic blocking agents, steroid agents or non-steroid anti-inflammatory drugs (NSAIDs). Postoperative exclusion criteria includes the patients who are in need of inspiratory oxygen fraction > 0.6 or positive end-expiratory pressure > 5 cmH2O during mechanical ventilation, dopamine > 3 microgram/kg/min, insulin, diuretic drugs, NSAIDs or beta-adrenergic blocking agents during intensive care unit stay.
Target sample size	20

Research contact person
Name of lead principal investigator	Ryuichi Nakanuno
Organization	Hiroshima University Hospital
Division name	Department of Anesthesiology and Critical Care
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL	082-257-5267
Email	nakanuno@hiroshima-u.ac.jp

Public contact
Name of contact person	Ryuichi Nakanuno
Organization	Hiroshima University Hospital
Division name	Department of Anesthesiology and Critical Care
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL	082-257-5267
Homepage URL
Email	nakanuno@hiroshima-u.ac.jp

Sponsor
Institute	Department of Anesthesiology and Critical Care, Hiroshima University Hospital
Institute
Department

Funding Source
Organization	The Hiroshima University Support Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	2012 Year 10 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 07 Month 01 Day
Anticipated trial start date	2007 Year 07 Month 02 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	Propofol anesthesia and postoperative propofol sedation resulted in a reduced peak postoperative bladder temperature and lower postoperative C-reactive protein levels than sevoflurane anesthesia followed by midazolam sedation. However, propofol infusion did not show significant effect on energy expenditure, fat metabolism, protein catabolism and clinical courses.
Other related information

Management information
Registered date	2012 Year 10 Month 02 Day
Last modified on	2018 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010588