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Pharmacodynamic model of effect-site concentration of propofol for loss of consciousness in the patients done neoadjuvant chemotherapy for breast cancer.

Status Approved

First Submitted Date

2020/05/18
Registered Date

2020/07/06
Last Updated Date

2020/05/27

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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	KCT0005199
Unique Protocol ID	19-0171
Public/Brief Title	Effect-site concentration of propofol for loss of consciousness in the patients done neoadjuvant chemotherapy for breast cancer.
Scientific Title	Pharmacodynamic model of effect-site concentration of propofol for loss of consciousness in the patients done neoadjuvant chemotherapy for breast cancer.
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
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	19-0171
Approval Date	2019-10-28
Institutional Review Board Name	IRB of Inje University Busan Paik Hospital
Institutional Review Board Address	81, Jinsa-ro 83beon-gil, Busanjin-gu, Busan, Republic of Korea
Institutional Review Board Telephone	051-890-8954
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	seunghee ki
Title	assistant professor
Telephone	+82-51-890-6520
Affiliation	Inje University Busan Paik Hospital
Address	75, Bokji-ro, Busanjin-gu, Busan, Republic of Korea
Contact Person for Public Queries
Name	seunghee ki
Title	assistant professor
Telephone	+82-51-890-6520
Affiliation	Inje University Busan Paik Hospital
Address	75, Bokji-ro, Busanjin-gu, Busan, Republic of Korea
Contact Person for Updating Information
Name	seunghee ki
Title	assistant professor
Telephone	+82-51-890-6520
Affiliation	Inje University Busan Paik Hospital
Address	75, Bokji-ro, Busanjin-gu, Busan, Republic of 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	Recruiting
Date of First Enrollment	2019-11-05 Actual
Target Number of Participant	50
Primary Completion Date
Study Completion Date	2022-12-31 , Anticipated
Name of Study	Inje University Busan Paik Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2019-11-05 ,

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	Inje University Busan Paik Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Inje University Busan Paik Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Neurotoxicity from chemotherapy may alter the nervous system and affect sensitivity to anesthetic agents. We explore the pharmacodynamic model by comparing the median effective effect-site concentration (EC50), which causes loss of consciousness when inducing anesthesia in patients between who did adjuvant chemotherapy and who did not before surgery We started propofol infusion by effect-site concentration of 1.5 μg/ml, and increased by 0.2 μg/ml when effect-site concentration equals to plasma concentration. If Modified Observer’s Assessment of Alertness/Sedation scale(MOAA/S) score changes, we maintained effect-site concentration for 2 minutes and then increased by 0.2 μg/ml. We maintained increasing effect-site concentration of propofol until the MOAA/s score becomes 0. After then the study finishes.

Study Summary Information

Lay Summary

Neurotoxicity from chemotherapy may alter the nervous system and affect sensitivity to anesthetic agents. We explore the pharmacodynamic model by comparing the median effective effect-site concentration (EC50), which causes loss of consciousness when inducing anesthesia in patients between who did adjuvant chemotherapy and who did not before surgery
We started propofol infusion by effect-site concentration of 1.5 μg/ml, and increased by 0.2 μg/ml when effect-site concentration equals to plasma concentration. If Modified Observer’s Assessment of Alertness/Sedation scale(MOAA/S) score changes, we maintained effect-site concentration for 2 minutes and then increased by 0.2 μg/ml. We maintained increasing effect-site concentration of propofol until the MOAA/s score becomes 0. After then the study finishes.

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	50
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label the experimental group
Cohort/ Group 1	Cohort/Group Description Patients undergoing breast cancer sugery with general anesthesia, who did neoadjuvant chemotherapy for breast cancer before surgery, age between 19-75 years old , BMI 18-29.9 kg/m2, ASA class(american society of anesthesiologists classification) 1-3 . The purpose of the study is to investigate effect-site concentration of propofol for loss of consciousness in the patients done chemotherapy during induction of anesthesia using target-controlled infusion of propofol
Cohort/ Group 2	Cohort/Group Label the comparison group
Cohort/ Group 2	Cohort/Group Description Patients undergoing breast cancer sugery with general anesthesia, who did not do neoadjuvant chemotherapy for breast cancer before surgery, age between 19-75 years old , BMI 18-29.9 kg/m2, ASA class(american society of anesthesiologists classification) 1-3 . The purpose of the study is to investigate effect-site concentration of propofol for loss of consciousness in the patients done chemotherapy during induction of anesthesia using target-controlled infusion of propofol
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Patients undergoing breast cancer surgery under general anesthesia
Sampling Method	stratified random sampling : In the study population, patients with a history of chemotherapy for breast cancer before surgery were assigned to the experimental group, and patients without a history of chemotherapy were assigned to the control group
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C50.99)Malignant neoplasm of breast unspecified, unspecified side breast neoplasm
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~75Year
	Description breast cancer sugery with general anesthesia, who did neoadjuvant chemotherapy for breast cancer before surgery, age between 19-75 years old , BMI 18-29.9 kg/m2, ASA class(american society of anesthesiologists classification) 1-3
Exclusion Criteria	patiens with neurologic or psychologic disorder history, take sedative drug, chronic alocoholics, high risk patients of airway obstruction during sedation, difficulty in communication, history of neoadjuvant chemotherapy for cancer other than breast cancer before sugery
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	&Pharmacokinetics/dynamics
Outcome	MOAA/S (modified observer’s assessment of alertness/sedation scale) score and BIS score
Timepoint	every 30 seconds after starting propofol infusion
Secondary Outcome(s) 1
Outcome	Plasma concentration of propofol
Timepoint	when MOAA/S (modified observer’s assessment of alertness/sedation scale) score changes

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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