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Comparison of the effect of propofol and desflurane on Serum S-100 β and GFAP release during controlled hypotension.

Status Approved

First Submitted Date

2018/01/05
Registered Date

2018/02/20
Last Updated Date

2018/01/22

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002698
Unique Protocol ID	2017-74
Public/Brief Title	Comparison of the effect of propofol and desflurane on S-100 β and GFAP release during controlled hypotension.
Scientific Title	Comparison of the effect of propofol and desflurane on Serum S-100 β and GFAP release during controlled hypotension.
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2017-74
Approval Date	2017-09-12
Institutional Review Board Name	The institutional review board of Hallym University Chuncheon Sacred Heart Hospital
Institutional Review Board Address	Sakju-ro 77, Chuncheosn-si, Gangwon-do
Institutional Review Board Telephone	033-240-5128
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Sung Mi Hwang
Title	Professor
Telephone	+82-33-240-5155
Affiliation	Hallym University Medical Center- Chuncheon
Address	77 Sakju-ro, Chuncheon-si, Gangwon-do, 24253, South Korea
Contact Person for Public Queries
Name	Sung Mi Hwang
Title	Professor
Telephone	+82-33-240-5155
Affiliation	Hallym University Medical Center- Chuncheon
Address	77 Sakju-ro, Chuncheon-si, Gangwon-do, 24253, South Korea
Contact Person for Updating Information
Name	Sung Mi Hwang
Title	Professor
Telephone	+82-33-240-5155
Affiliation	Hallym University Medical Center- Chuncheon
Address	77 Sakju-ro, Chuncheon-si, Gangwon-do, 24253, South Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2018-02-05 Anticipated
Target Number of Participant	60
Primary Completion Date	2018-05-31 , Anticipated
Study Completion Date	2018-06-08 , Anticipated
Name of Study	Hallym University Medical Center- Chuncheon
Recruitment Status	Not yet recruiting
Date of First Enrollment	2018-02-05 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Hallym University
Organization Type	University
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Hallym University Medical Center- Chuncheon
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Excessive bleeding during FESS can increase complications. Although controlled hypotension anesthesia and the reverse Trendelenburg position can help facilitate FESS, complications related to low blood pressure cannot be overlooked. Postoperative cognitive deficits, organ hypoperfusion, subsequent hypoxia, and potential neurological injury can result after controlled hypotension.Subtle neurocognitive dysfunction and transient cerebral ischemia after surgery cannot be detected readily in a routine clinical examination. The identification of a biochemical serum marker to assist the diagnosis of cerebral ischemic injury would potentially be useful immediately after surgery. S-100β and GFAP (glial fibrillary acidic protein) are early biomarker for changes associated with cerebral ischemia, and slightly elevated levels may be an early sign of future neuronal damage. The combination of propofol and remifentanil is known to provide the ‘best’ control of hypotension, with safety and ease of use. So, they are recommended for endoscopic sinus surgery which needs controlled hypotension to reduce bleeding and faciliate the operation field. Beyond these advantages, we aime to investigate the effect on the levels of S 100 β와 GFAP which are early markers of cerebral ischemia known as a biomarker by comparing with desflurane-remifentanil anesthesia.

Study Summary Information

Lay Summary

 Excessive bleeding during FESS can increase complications. Although controlled hypotension anesthesia and the reverse Trendelenburg position can help facilitate FESS, complications related to low blood pressure cannot be overlooked. Postoperative cognitive deficits, organ hypoperfusion, subsequent hypoxia, and potential neurological injury can result after controlled hypotension.Subtle neurocognitive dysfunction and transient cerebral ischemia after surgery cannot be detected readily in a routine clinical examination. 
The identification of a biochemical serum marker to assist the diagnosis of cerebral ischemic injury would potentially be useful immediately after surgery. S-100β and GFAP (glial fibrillary acidic protein)  are early biomarker for changes associated with cerebral ischemia, and slightly elevated levels may be an early sign of future neuronal damage.
The combination of propofol and remifentanil is known to provide the ‘best’ control of hypotension, with safety and ease of use. So, they are recommended for endoscopic sinus surgery which needs controlled hypotension to reduce bleeding and faciliate the operation field. Beyond these advantages, we aime to investigate the effect on the levels of S 100 β와 GFAP which are early markers of cerebral ischemia  known as a biomarker by comparing with desflurane-remifentanil anesthesia.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Drug
Intervention Description	We are to compare the levels of S 100 β and GFAP acoording to propofol or desflurane anesthesia when controlled hypotension is used for endoscopic sinus surgery
Number of Arms	2
Arm 1	Arm Label group P
	Target Number of Participant 30
	Arm Type Experimental
	Arm Description Anesthesia is maintained by propofol(TCI 3-5 ng/ml), remifentanil, and rocuronium
Arm 2	Arm Label group D
	Target Number of Participant 30
	Arm Type Experimental
	Arm Description Anesthesia is maintained by desflurane, remifentanil, and rocuronium

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (J00-J99)Diseases of the respiratory system (J32.9)Chronic sinusitis, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~70Year
	Description 1) 20-70 years old mal and female 2) American Society of Anesthesiologist (ASA) class 1,2 3) patients undergoing endoscopic sinus surgery under general anesthesia with controlled hypotension
Exclusion Criteria	patients with 1) History of cerebrovascular Disease 2) history of brain surgery 3) uncontrolled hypertension 4) history of angina 5) renal disease 6) anemia
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	plasma S 100 β와 GFAP level
Timepoint	after anesthesia induction (T0), 20 min after controlled hypotension (T1), at end of operation (T2). 30 min and 60 min after end of operation (T3),(T4)
Secondary Outcome(s) 1
Outcome	blood pressure, endtidal CO2
Timepoint	10 min interval after anesthesia induction

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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