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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003328
Receipt No. 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

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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
Email

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
Email y_nomura@seichokai.or.jp

Sponsor
Institute Bellland General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004041

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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