UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003328 |
|---|---|
| Receipt number | R000004041 |
| Scientific Title | Effects of general anesthetic agents on intraocular pressure increase during laparoscopic colectomy or proctectomy: a comparison of propofol with sevoflurane |
| Date of disclosure of the study information | 2010/03/13 |
| Last modified on | 2010/10/13 13:03:21 |
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Basic information
Public title
Effects of general anesthetic agents on intraocular pressure increase during laparoscopic colectomy or proctectomy: a comparison of propofol with sevoflurane
Acronym
Effects of general anesthetic agents on intraocular pressure increase during laparoscopic colectomy or proctectomy
Scientific Title
Effects of general anesthetic agents on intraocular pressure increase during laparoscopic colectomy or proctectomy: a comparison of propofol with sevoflurane
Scientific Title:Acronym
Effects of general anesthetic agents on intraocular pressure increase during laparoscopic colectomy or proctectomy
Region
| Japan |
Condition
Condition
colonic or rectal disease requiring surgery (patients undergoing laparoscopic colectomy or proctectomy)
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the effects of general anesthetic agents on intraocular pressure increase during laparoscopic colectomy or proctectomy between propofol and sevoflurane.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
intraocular pressure
1)before induction of general anesthesia
2)just after induction of general anesthesia
3)just after pneumoperitoneum achievement
4)just after position changing to Trendelenburg (head lower) position
5)just after changing to flat position
6)just after terminating pneumoperitoneum
7)just after extubation
Key secondary outcomes
blood pressure, heart rate, body temperature, airway pressure, endtidal carbon dioxide, tilt angle of the bed, partial carbon dioxide pressure in arterial blood, operative time, anesthetic time, total fluid infusion, total operative bleeding, total volume of urine, total transfusion, total dose of fentanyl, total dose of remifentanil, visual dysfunction after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Propofol group: administration of propofol (5-6 mg/kg/hr) for sedative
Interventions/Control_2
Sevoflurane group: administration of sevoflurane (1-1.5%) for sedative
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients undergoing laparoscopic colectomy or proctectomy
Key exclusion criteria
patients with glaucoma, obstractive pulmonary disease (FEV1%<50), without informed concent, past history of jaundice or high fever with volatile anesthetics, pregnant woman, past history of abnormal reaction to
sevoflurane or propofol, patients recongnised as inadequate for this study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasumitsu Nomura |
Organization
Bellland General Hospital
Division name
Department of Anesthesia
Zip code
Address
500-3 Higashiyama, Naka-ku, Sakai, Osaka, 599-8247, Japan
TEL
072-234-2001
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasumitsu Nomura |
Organization
Bellland General Hospital
Division name
Department of Anesthesia
Zip code
Address
500-3 Higashiyama, Naka-ku, Sakai, Osaka, 599-8247, Japan
TEL
072-234-2001
Homepage URL
y_nomura@seichokai.or.jp
Sponsor or person
Institute
Bellland General Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Nara Medical University
Organization
Division
Category of Funding Organization
Local Government
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
ベルランド総合病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2009 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 13 | Day |
Last modified on
| 2010 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004041
