UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033994
Receipt number R000038763
Scientific Title 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 18:30:49

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Basic information

Public title

Comparing effects of desflurane and sevoflurane on arthroscopic visibility in shoulder surgery

Acronym

the effects of desflurane on the visibility of arthroscopic shoulder surgery

Scientific Title

Comparing effects of desflurane and sevoflurane on arthroscopic visibility in shoulder surgery

Scientific Title:Acronym

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

1st name
Middle name
Last name Jae Ho Lee

Organization

National Health Insurance Service, Ilsan Hospital

Division name

Anesthesiology and Pain medicine

Zip code


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

1st name
Middle name
Last name Jae Ho Lee

Organization

National Health Insurance Service, Ilsan Hospital

Division name

Anesthesiology and Pain medicine

Zip code


Address

100, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea, 10444

TEL

821032231229

Homepage URL


Email

lijhmd71@hotmail.com


Sponsor or person

Institute

National Health Insurance Service, Ilsan Hospital

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 05 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

2018 Year 03 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.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