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Effect of ramosetron on effect-site concentration of remifentanil for preventing emergence cough during general anesthesia in female patients undergoing laparoscopic cholecystectomy

Status Approved

First Submitted Date

2020/09/17
Registered Date

2020/09/25
Last Updated Date

2020/09/17

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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	KCT0005441
Unique Protocol ID	AJIRB-MED-THE-20-174
Public/Brief Title	Effect of Ramosetron on Remifentanil for Preventing Emergence Cough in Female
Scientific Title	Effect of ramosetron on effect-site concentration of remifentanil for preventing emergence cough during general anesthesia in female patients undergoing laparoscopic cholecystectomy
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	AJIRB-MED-THE-20-174
Approval Date	2020-07-23
Institutional Review Board Name	Ajou University Hospital Institutional Review Board
Institutional Review Board Address	164, World cup-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do
Institutional Review Board Telephone	031-219-5569
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	Ji Eun Kim
Title	Professor
Telephone	+82-31-219-5575
Affiliation	Ajou University Hospital
Address	Ajou University School of Medicine
Contact Person for Public Queries
Name	Ji Eun Kim
Title	Professor
Telephone	+82-31-219-5575
Affiliation	Ajou University Hospital
Address	Ajou University School of Medicine
Contact Person for Updating Information
Name	Ji Eun Kim
Title	Professor
Telephone	+82-31-219-5575
Affiliation	Ajou University Hospital
Address	Ajou University School of Medicine

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	2020-10-01 Anticipated
Target Number of Participant	50
Primary Completion Date
Study Completion Date
Name of Study	Ajou University Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-10-01 ,

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	Ajou University Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

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

7. Study Summary

Study Summary Information
Lay Summary	Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion. The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in female patients who receive the ramosetron or not.

Study Summary Information

Lay Summary

Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.
The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in female patients who receive the ramosetron or not.

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	Prevention
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator, Outcome Accessor
Allocation	RCT
Intervention Type	Drug
Intervention Description	Control group receives the intravenous normal saline 2 mL. Ramosetron group receives the intravenous Ramosetron 2 mL (0.3 mg).
Number of Arms	2
Arm 1	Arm Label Control group
	Target Number of Participant 25
	Arm Type Placebo comparator
	Arm Description Control group receives the intravenous normal saline 2 mL.
Arm 2	Arm Label Ramosetron group
	Target Number of Participant 25
	Arm Type Experimental
	Arm Description Ramosetron group receives the intravenous Ramosetron 2 mL (0.3 mg).

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (K00-K93)Diseases of the digestive system (K82.9)Disease of gallbladder, unspecified Gallbladder Diseases
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 19Year~85Year
	Description Laparoscopic cholecystectomy under general anesthesia
Exclusion Criteria	BMI > 30 kg/m2, respiratory infection, uncontrolled hypertension
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	Efficacy
Outcome	optimal Ce of remifentanil
Timepoint	at extubation
Secondary Outcome(s) 1
Outcome	complications, emergence time, pain score
Timepoint	from anesthetic emergence until stay at post-anesthesia care unit

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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