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Comparison of intravenous alfentanil and intravenous oxycodone in patient-controlled analgesia after laparoscopic cholecystectomy

Status Approved

First Submitted Date

2015/08/24
Registered Date

2016/07/05
Last Updated Date

2016/06/30

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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	KCT0001962
Unique Protocol ID	2014-78
Public/Brief Title	Comparison of intravenous alfentanil and intravenous oxycodone in patient-controlled analgesia after laparoscopic cholecystectomy
Scientific Title	Comparison of intravenous alfentanil and intravenous oxycodone in patient-controlled analgesia after laparoscopic cholecystectomy
Acronym	CIAOPLC
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	2014-78
Approval Date	2014-08-29
Institutional Review Board Name	Chuncheon Sacred heart hospital Institusional Review Board/Ethics Committee
Institutional Review Board Address
Institutional Review Board Telephone
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	So Young Lim
Title	professor
Telephone	+82-33-240-5594
Affiliation	Hallym University Medical Center- Chuncheon
Address	Sakju-ro 77, Chuncheon-si, Gangwon-do
Contact Person for Public Queries
Name	Young Suk Kwon
Title	fellow
Telephone	+82-33-240-5594
Affiliation	Hallym University Medical Center- Chuncheon
Address	Sakju-ro 77, Chuncheon-si, Gangwon-do
Contact Person for Updating Information
Name	Young Suk Kwon
Title	fellow
Telephone	+82-33-240-5594
Affiliation	Hallym University Medical Center- Chuncheon
Address	Sakju-ro 77, Chuncheon-si, Gangwon-do

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	Completed
Date of First Enrollment	2014-10-22 Actual
Target Number of Participant	90
Primary Completion Date	2015-08-31 , Actual
Study Completion Date	2015-12-21 , Actual
Name of Study	Hallym University Medical Center- Chuncheon
Recruitment Status	Completed
Date of First Enrollment	2014-10-22 ,

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 Medical Center- Chuncheon
Organization Type	Medical Institute
Project ID	2014-78

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	Background:A safe recommended dose for the direct substitution between commonly used alfentanil and oxycodone on Patient controlled analgesia is a situation that is not established yet. Subjects: A voluntary agreement on the subject of intravenous patient controlled analgesia during patient who underwent a laparoscopy cholecystectomy Metrics: Visual analogue scale, sedation scale, cumulative dose, side effect Hypothesis: oxycodone would be comparable to the effect of alfentanil.

Study Summary Information

Lay Summary

Background:A safe recommended dose for the direct substitution between commonly used alfentanil and oxycodone on Patient controlled analgesia is a situation that is not established yet.
Subjects: A voluntary agreement on the subject of intravenous patient controlled analgesia during patient who underwent a laparoscopy cholecystectomy
Metrics: Visual analogue scale, sedation scale, cumulative dose, side effect
Hypothesis: oxycodone would be comparable to the effect of alfentanil.

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	Prospective
Target Number of Participant	90
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label alfentanil group
Cohort/ Group 1	Cohort/Group Description Alfentanil used group in patient controlled analgesia has comulative dose, visual analogue scale(VAS), side effect, satisfaction and sedation scale will be observed
Cohort/ Group 2	Cohort/Group Label oxycodone group
Cohort/ Group 2	Cohort/Group Description Oxycodone used group in patient controlled analgesia has comulative dose, visual analogue scale(VAS), side effect, satisfaction and sedation scale will be observed
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Who underwent a laparoscopic cholecystectomy patients over the age of 18 to 70 years of age
Sampling Method	After making table of random numbers of 1 or 2 by Microsoft Excel, 1 is alfentanil group and 2 is oxycodone group
Condition(s)/Problem(s)	* (K00-K93)Diseases of the digestive system (K80.00)Calculus of gallbladder with acute cholecystitis, without mention of obstruction
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~70Year
	Description Of patients who underwent laparoscopic cholecystectomy targeting 90 people belonging to ASA(American society of anesthesiologyists) physical status classification class I or II. Between the ages of 18-70, both men and ladies were included.
Exclusion Criteria	Patients who used preoperative periodically acetaminophen or non-steroidal anti-inflammatory drugs or opioids, patients who could not express Numerical rating scale (NRS), patients who had abnormal liver and kidney function and pregnant patients were excluded.
Healthy Volunteers

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	Not applicable
Outcome	Cumulative PCA(Patient controlled analgesia ) dose
Timepoint	1,4,8,16,24,48 hours after operation
Secondary Outcome(s) 1
Outcome	Visual analogue scale
Timepoint	1,4,8,16,24,48 hours after operation
Secondary Outcome(s) 2
Outcome	sedation scale
Timepoint	1,4,8,16,24,48 hours after operation
Secondary Outcome(s) 3
Outcome	satisfaction
Timepoint	48 hours after operation
Secondary Outcome(s) 4
Outcome	side effect
Timepoint	1,4,8,16,24,48 hours after operation

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

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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