임상연구정보서비스

Search: Search

Effect of use of Nasea (ramosetron) and dexamethasone on postoperative recovery in surgery without patient controlled analgesia (PCA) after surgery; Randomized Controlled Trials

Status Approved

First Submitted Date

2022/02/06
Registered Date

2022/02/18
Last Updated Date

2023/12/05

Move list page

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	KCT0007007
Unique Protocol ID	2022AS0027
Public/Brief Title	Effect of use of Nasea (ramosetron) and dexamethasone on postoperative recovery in surgery without patient controlled analgesia (PCA) after surgery; Randomized Controlled Trials
Scientific Title	Effect of use of Nasea (ramosetron) and dexamethasone on postoperative recovery in surgery without patient controlled analgesia (PCA) after surgery; Randomized Controlled Trials
Acronym
MFDS Regulated Study	Yes
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Submitted approval

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2022AS0027
Approval Date	2022-01-25
Institutional Review Board Name	Korea University Ansan Hospital Institutional Review Board
Institutional Review Board Address	15355, 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do (Gojan-dong)
Institutional Review Board Telephone	02-412-6514
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	YOON JI CHOI
Title	associate professor
Telephone	+82-31-412-5289
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do
Contact Person for Public Queries
Name	YOON JI CHOI
Title	associate professor
Telephone	+82-31-412-5289
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do
Contact Person for Updating Information
Name	YOON JI CHOI
Title	associate professor
Telephone	+82-31-412-5289
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-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	Multi-center Number of center : 5
Overall Recruitment Status	Recruiting
Date of First Enrollment	2023-03-07 Actual
Target Number of Participant	400
Primary Completion Date	2024-05-31 , Anticipated
Study Completion Date	2024-05-31 , Anticipated
Name of Study	Korea University Ansan Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2023-03-07 ,
Recruitment Status by Participating Study Site 2
Name of Study	Chonnam National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2023-04-17 ,
Recruitment Status by Participating Study Site 3
Name of Study	Kyungpook National University Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2023-04-04 ,
Recruitment Status by Participating Study Site 4
Name of Study	Chungnam National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2023-06-05 ,
Recruitment Status by Participating Study Site 5
Name of Study	Ajou University Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2023-12-09 ,

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	Daiichi-Sankyo Korea
Organization Type	Pharmaceutical Company
Project ID

6. Sponsor Organization

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

7. Study Summary

Study Summary Information
Lay Summary	Although the mechanism of postoperative nausea vomiting (PONV) has not yet been clearly elucidated, the factors related to surgery include laparoscopic surgery, gastrointestinal surgery, orthopedic surgery, strabismus surgery, breast surgery, and plastic surgery. These include the use of inhaled anesthetics, nitrous oxide, and opioids. Accordingly, a selective antagonist of 5-HT3 receptor was developed as an antiemetic agent. In particular, ramosetron, a selective antagonist of 5-HT3 receptor, has a higher potency and longer duration of action than existing serotonin receptor antagonists, so 0.3 mg is administered intravenously to adults. Thus, there is a report that it significantly reduced the incidence of postoperative nausea and vomiting PONV in patients with laparoscopic cholecystectomy, arthroplasty, spinal surgery, and gynecological surgery, and showed similar or better effects compared to ondansetron. However, in many cases where postoperative painless injection of patient controlled analgesia (PCA) is not performed, prophylactic antiemetics are not used in many cases. Postoperative nausea and vomiting in patients who have a high risk of nausea and vomiting in patients undergoing surgery with a high incidence of postoperative nausea and vomiting (PONV), such as (neuro·orthopedic surgery), plastic surgery (plastic surgery), and otorhinolaryngology surgery Because patients are more likely to suffer from (PONV), ramosetron is mainly used. However, it is still insufficient to prevent nausea and vomiting. Therefore, it is necessary to compare the possibility of postoperative nausea and vomiting (PONV) when co-administered with dexamethasone. Therefore, the purpose of this study is to compare the antiemetic prophylaxis effect of co-administration of dexamethasone in a situation where PCA (patient controlled analgesia) is not performed after surgery.

Study Summary Information

Lay Summary

Although the mechanism of postoperative nausea vomiting (PONV) has not yet been clearly elucidated, the factors related to surgery include laparoscopic surgery, gastrointestinal surgery, orthopedic surgery, strabismus surgery, breast surgery, and plastic surgery. These include the use of inhaled anesthetics, nitrous oxide, and opioids.
Accordingly, a selective antagonist of 5-HT3 receptor was developed as an antiemetic agent. In particular, ramosetron, a selective antagonist of 5-HT3 receptor, has a higher potency and longer duration of action than existing serotonin receptor antagonists, so 0.3 mg is administered intravenously to adults. Thus, there is a report that it significantly reduced the incidence of postoperative nausea and vomiting PONV in patients with laparoscopic cholecystectomy, arthroplasty, spinal surgery, and gynecological surgery, and showed similar or better effects compared to ondansetron.
However, in many cases where postoperative painless injection of patient controlled analgesia (PCA) is not performed, prophylactic antiemetics are not used in many cases. Postoperative nausea and vomiting in patients who have a high risk of nausea and vomiting in patients undergoing surgery with a high incidence of postoperative nausea and vomiting (PONV), such as (neuro·orthopedic surgery), plastic surgery (plastic surgery), and otorhinolaryngology surgery Because patients are more likely to suffer from (PONV), ramosetron is mainly used. However, it is still insufficient to prevent nausea and vomiting.
Therefore, it is necessary to compare the possibility of postoperative nausea and vomiting (PONV) when co-administered with dexamethasone.
Therefore, the purpose of this study is to compare the antiemetic prophylaxis effect of co-administration of dexamethasone in a situation where PCA (patient controlled analgesia) is not performed after surgery.

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
Allocation	RCT
Intervention Type	Drug
Intervention Description	# Treatment group: Dexamethasone 5 mg (0.15 mg/kg) iv after induction of anesthesia, and Ramosetron 0.3 mg (6 μg/kg) iv before the end of surgery. # Active Control group: Ramosetron 0.3 mg (6 μg/kg) iv before the end of surgery.
Number of Arms	2
Arm 1	Arm Label Treatment group
	Target Number of Participant 200
	Arm Type Experimental
	Arm Description Dexamethasone 5 mg (0.15 mg/kg) iv after induction of anesthesia, and Ramosetron 0.3 mg (6 μg/kg) iv before the end of surgery.
Arm 2	Arm Label (Active Control group)
	Target Number of Participant 200
	Arm Type Active comparator
	Arm Description Ramosetron 0.3 mg (6 μg/kg) iv before the end of surgery.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C50.0)Malignant neoplasm of nipple and areola Type of surgery: general surgery, gynecological surgery, neuro-orthopedic surgery, plastic surgery, otolaryngology surgery
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~80Year
	Description  Patients 19 years of age or older  Patients managed without Patient Controlled Analgesia (PCA) after surgery  Type of surgery: general surgery, gynecological surgery, neuro-orthopedic surgery, plastic surgery, otolaryngology surgery  Patient who signs informed consent (ICF)
Exclusion Criteria	 Under 19 years  Pregnant or lactating women  Patients with hypersensitivity to the test drug (dexamethason)  Patients who have received antiemetics, steroids, antihistamines, etc. or psychotropic drugs that may affect postoperative nausea and vomiting within 24 hours before surgery  Patients with suspected hepato-renal disorders  Contraindicated administration of dexamethasone, ramosetron, metoclopramide
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	verbal numerical rating scale (VNRS) was used to evaluate the patient's nausea and vomiting at 6, 12, and 24 hours after surgery.
Timepoint	at 6, 12, and 24 hours after surgery.
Secondary Outcome(s) 1
Outcome	PONV incidence by surgery
Timepoint	at 6, 12, and 24 hours after surgery.
Secondary Outcome(s) 2
Outcome	PONV incidence by risk factor score (age, underlying disease, gender, previous history of nausea and vomiting, medications taken, etc.)
Timepoint	at 6, 12, and 24 hours after surgery.
Secondary Outcome(s) 3
Outcome	Pain control (VAS) between ramosetron versus ramosetron + dexamethasone: reduced VAS compared to baseline
Timepoint	at 6, 12, and 24 hours after surgery.
Secondary Outcome(s) 4
Outcome	Use of the frequency of rescue drug with ramosetron and ramosetron + dexamethasone
Timepoint	at 6, 12, and 24 hours after surgery.
Secondary Outcome(s) 5
Outcome	Side effects after drug injection
Timepoint	at 6, 12, and 24 hours after surgery.

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

Move list page Move to top