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Nerve block reduces the postoperative agitated behavior compared to the neuraxial anesthesia: a retrospective observational study

Status Approved

First Submitted Date

2018/08/16
Registered Date

2018/10/19
Last Updated Date

2018/10/08

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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	KCT0003279
Unique Protocol ID	HYUH 2018-07-006
Public/Brief Title	Nerve block reduces the postoperative agitated behavior compared to the neuraxial anesthesia: a retrospective observational study
Scientific Title	Nerve block reduces the postoperative agitated behavior compared to the neuraxial anesthesia: a retrospective observational study
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	HYUH 2018-07-006
Approval Date	2018-07-09
Institutional Review Board Name	Hanyang university seoul hospital
Institutional Review Board Address	222, Wangsimni-ro, Seongdong-gu, Seoul
Institutional Review Board Telephone	02-2220-0673
Data Monitoring Committee

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	Hyunyoung Lim
Title	Clinical assistant p
Telephone	+82-2-2290-8680
Affiliation	Hanyang University Seoul Hospital
Address	222-1 Wangsimni-ro, Seongdong-gu, Seoul 04763 South Korea
Contact Person for Public Queries
Name	Hyunyoung Lim
Title	Clinical assistant p
Telephone	+82-2-2290-8680
Affiliation	Hanyang University Seoul Hospital
Address	222-1 Wangsimni-ro, Seongdong-gu, Seoul 04763 South Korea
Contact Person for Updating Information
Name	Hyunyoung Lim
Title	Clinical assistant p
Telephone	+82-2-2290-8680
Affiliation	Hanyang University Seoul Hospital
Address	222-1 Wangsimni-ro, Seongdong-gu, Seoul 04763 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	2018-10-31 Anticipated
Target Number of Participant	1000
Primary Completion Date
Study Completion Date
Name of Study	Hanyang University Seoul Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2018-10-31 ,

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	Hanyang University Seoul Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Hanyang University Seoul Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Postoperative cognitive dysfunction is a dangerous complication that can worsen the prognosis of the patient. Although several methods have been studied to reduce this, no comparative studies have been published between spinal anesthesia and nerve block. In this study, we review the medical records for 3 years and determine the incidence of postoperative cognitive dysfunction according to anesthesia method. Postoperative cognitive dysfunction is a common complication after surgery, especially in elderly patients. Delirium can occur at any time during surgery, but it occurs most commonly after surgery. Also, it has the side effects of prolonging hospital stay, delaying functional recovery, and causing that increase treatment costs. Luckily, postoperative cognitive dysfunction can reduce its incidence by identifying risk factors and weakening the incidence. In one study, there was no significant difference between the two groups in the comparison between general anesthesia and nerve block. However, in another study, the incidence of delirium was higher in nerve block compared to epidural anesthesia. To date, no studies have compared nerve block with spinal anesthesia. The aim of this study was to compare the incidence of postoperative cognitive dysfunction according to two anesthetic methods.

Study Summary Information

Lay Summary

Postoperative cognitive dysfunction is a dangerous complication that can worsen the prognosis of the patient. Although several methods have been studied to reduce this, no comparative studies have been published between spinal anesthesia and nerve block. In this study, we review the medical records for 3 years and determine the incidence of postoperative cognitive dysfunction according to anesthesia method. 
Postoperative cognitive dysfunction is a common complication after surgery, especially in elderly patients. Delirium can occur at any time during surgery, but it occurs most commonly after surgery. Also, it has the side effects of prolonging hospital stay, delaying functional recovery, and causing that increase treatment costs. Luckily, postoperative cognitive dysfunction can reduce its incidence by identifying risk factors and weakening the incidence.
In one study, there was no significant difference between the two groups in the comparison between general anesthesia and nerve block. However, in another study, the incidence of delirium was higher in nerve block compared to epidural anesthesia.  To date, no studies have compared nerve block with spinal anesthesia. The aim of this study was to compare the incidence of postoperative cognitive dysfunction according to two anesthetic methods.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-control
Time Perspective	Retrospective
Target Number of Participant	1000
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label nerve block group
Cohort/ Group 1	Cohort/Group Description The medical records from January 1, 2015 to December 31, 2017, of patients who underwent surgery after nerve block in the operating room will be analyzed.Patients with cognitive dysfunction from the recovery room until discharge are identified and their incidence is analyzed.
Cohort/ Group 2	Cohort/Group Label neuraxial anesthesia group
Cohort/ Group 2	Cohort/Group Description The medical records from January 1, 2015 to December 31, 2017, of patients who underwent surgery after nerve block in the operating room will be analyzed.Patients with cognitive dysfunction from the recovery room until discharge are identified and their incidence is analyzed.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Patients undergoing surgery at Hanyang University Seoul Hospital
Sampling Method	From January 1, 2015 to December 31, 2017, the medical records of patients who underwent surgery after nerve block or neuraxial anesthesia in the operating room.
Condition(s)/Problem(s)	* (F00-F99)Mental and behavioural disorders (F05.8)Other delirium
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description Patients who underwent surgery after nerve block or neuraxial anesthesia
Exclusion Criteria	If records are missing, or if the anesthesia method changed during surgery.
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
Outcome	postoperative cognitive dysfunction
Timepoint	Immediately after the surgery until discharge.
Secondary Outcome(s) 1
Outcome	Analyzing the factors that cause postoperative dysfunction(age and history of stroke)
Timepoint	Immediately after the surgery until discharge.

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	Not provided at time of Registration

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