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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033994
Receipt No. R000038763
Official scientific title of the study Comparing effects of desflurane and sevoflurane on arthroscopic visibility in shoulder surgery
Date of disclosure of the study information 2018/09/05
Last modified on 2018/09/05

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Basic information
Official scientific title of the study Comparing effects of desflurane and sevoflurane on arthroscopic visibility in shoulder surgery
Title of the study (Brief title) the effects of desflurane on the visibility of arthroscopic shoulder surgery
Region
Asia(except Japan)

Condition
Condition see whether desflurane increases the pressure of the irrigation pump more than does sevoflurane in shoulder surgery under arthroscopy
Classification by specialty
Medicine in general Surgery in general Orthopedics
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we conducted this study to see whether desflurane increases the pressure of the irrigation pump more than does sevoflurane in shoulder surgery under arthroscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes the maximum pressure of water pump needed to achieve the clearest vision of the surgical site during the whole operating time.
Key secondary outcomes the surgical field visibility at the beginning of surgery and the systolic and diastolic blood pressure and pulse rate at the start of surgery, and at 20, 40, and 60 minutes after that.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The attending anesthesiologist recorded the maximum pressure of the water pump during the operation.
Interventions/Control_2 a surgical field visibility at the beginning of surgery and the systolic and diastolic blood pressure and pulse rate at start of surgery, and 20, 40, and 60 minutes after that. We also collected the length of surgery, amount of infused remifentanil, and the use of ephedrine.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing elective, unilateral rotator cuff repair surgery under general anesthesia without brachial plexus nerve block
Key exclusion criteria uncontrolled hypertension, a history of myocardial infarction, cerebral ischemia, cerebral hemorrhage and acute or chronic renal failure.
Target sample size 40

Research contact person
Name of lead principal investigator Jae Ho Lee
Organization National Health Insurance Service, Ilsan Hospital
Division name Anesthesiology and Pain medicine
Address 100, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea, 10444
TEL 821032231229
Email lijhmd71@hotmail.com

Public contact
Name of contact person Jae Ho Lee
Organization National Health Insurance Service, Ilsan Hospital
Division name Anesthesiology and Pain medicine
Address 100, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea, 10444
TEL 821032231229
Homepage URL
Email lijhmd71@hotmail.com

Sponsor
Institute National Health Insurance Service, Ilsan Hospital
Institute
Department

Funding Source
Organization National Health Insurance Service, Ilsan Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2018 Year 09 Month 05 Day

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 03 Month 01 Day
Anticipated trial start date
2018 Year 03 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 Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 09 Month 02 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038763

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/09/02 2018 data-1.xlsx


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