UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009023 |
|---|---|
| Receipt number | R000010588 |
| Scientific Title | Effects of perioperative propofol infusion on energy expenditure, fat metabolism, protein catabolism and clinical courses following esophageal cancer surgery |
| Date of disclosure of the study information | 2012/10/03 |
| Last modified on | 2018/04/08 00:56:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of perioperative propofol infusion on energy expenditure, fat metabolism, protein catabolism and clinical courses following esophageal cancer surgery
Acronym
Comparison of two different anaesthesia/sedation techniques in esophageal cancer surgery : propofol anaesthesia/propofol sedation and sevoflurane anaesthesia/midazolam sedation
Scientific Title
Effects of perioperative propofol infusion on energy expenditure, fat metabolism, protein catabolism and clinical courses following esophageal cancer surgery
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Ryuichi Nakanuno |
Organization
Hiroshima University Hospital
Division name
Department of Anesthesiology and Critical Care
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5267
nakanuno@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuichi Nakanuno |
Organization
Hiroshima University Hospital
Division name
Department of Anesthesiology and Critical Care
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5267
Homepage URL
nakanuno@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care, Hiroshima University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 07 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010588
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
