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Postoperative nausea and vomiting: low dose versus high dose of remifentanil

Status Approved

First Submitted Date

2011/08/09
Registered Date

2011/09/09
Last Updated Date

2015/06/19

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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	KCT0000185
Unique Protocol ID	KUH1160020
Public/Brief Title	Postoperative nausea and vomiting: low dose versus high dose of remifentanil
Scientific Title	Postoperative nausea and vomiting: low dose versus high dose of remifentanil
Acronym
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	KUH1160020
Approval Date	2011-06-30
Institutional Review Board Name	Institutional Review Board for Human Research, Konkuk University Hospital
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	Yes Institutional Review Board for Human Research, Konkuk University Hospital

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	Seong-Hyop Kim
Title	M.D., Ph.D.
Telephone	+82-2-2030-5454
Affiliation	Konkuk University
Address
Contact Person for Public Queries
Name	Woon-Seok Kang
Title	M.D.
Telephone	+82-2-2030-5448
Affiliation	Konkuk University
Address
Contact Person for Updating Information
Name	Woon-Seok Kang
Title	M.D.
Telephone	+82-2-2030-5448
Affiliation	Konkuk University
Address

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	2011-07-05 Actual
Target Number of Participant	126
Primary Completion Date	2013-05-09 , Actual
Study Completion Date	2013-05-09 , Actual
Name of Study	Konkuk University
Recruitment Status	Completed
Date of First Enrollment	2011-07-05 ,

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	Konkuk University
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

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

7. Study Summary

Study Summary Information
Lay Summary	Postoperative nausea and vomiting (PONV) is a major concern in patient undergoing general anaesthesia, and may increase patient’s discomfort, delay of discharge and increase care cost. Inhalational anaesthetic agents are well known as emetic contributors and total intravenous anaesthesia (TIVA) is preferred to avoid PONV for patient undergoing general anaesthesia. For the better haemodynamic and surgical states, the combination of propofol as a hypnotic agent and remifentanil as an analgesic agent is the most popular TIVA technique. Remifentanil is an esterase metabolized opioid with a rapid clearance and widely used in general anaesthesia, especially for outpatient. As a result of rapid clearance characteristics, it is expected that remifentanil has fewer PONV though opioid is a risk factor of PONV. However, there are no studies about PONV with low-dose versus high-dose of remifentanil. Authors hypothesized that rapid clearance characteristics of remifentanil showed no difference of PONV between low-dose and high-dose of remifentanil. In the study, we compared PONV between low-dose versus high-dose of remifentanil in local excision of breast.

Study Summary Information

Lay Summary

 Postoperative nausea and vomiting (PONV) is a major concern in patient undergoing general anaesthesia, and may increase patient’s discomfort, delay of discharge and increase care cost. Inhalational anaesthetic agents are well known as emetic contributors and total intravenous anaesthesia (TIVA) is preferred to avoid PONV for patient undergoing general anaesthesia. For the better haemodynamic and surgical states, the combination of propofol as a hypnotic agent and remifentanil as an analgesic agent is the most popular TIVA technique. 
Remifentanil is an esterase metabolized opioid with a rapid clearance and widely used in general anaesthesia, especially for outpatient. As a result of rapid clearance characteristics, it is expected that remifentanil has fewer PONV though opioid is a risk factor of PONV. 
However, there are no studies about PONV with low-dose versus high-dose of remifentanil. Authors hypothesized that rapid clearance characteristics of remifentanil showed no difference of PONV between low-dose and high-dose of remifentanil. In the study, we compared PONV between low-dose versus high-dose of remifentanil in local excision of breast.

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	Diagnosis
Phase	Phase4
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	continuous infusion of propofol and remifentanil using TCI
Number of Arms	2
Arm 1	Arm Label low dose remifentanil
	Target Number of Participant 63
	Arm Type Experimental
	Arm Description remifentanil 5 ng/ml using TCI and propofol concentration adjusted with BIS between 40-60
Arm 2	Arm Label high dose remifentanil
	Target Number of Participant 63
	Arm Type Experimental
	Arm Description remifentanil 10 ng/ml using TCI and propofol concentration adjusted with BIS between 40-60

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (D24.99)Benign neoplasm of breast, unspecified, unspecified side
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 19Year~100Year
	Description patients undergoing local excision of benign breast mass with general anesthesia in admission
Exclusion Criteria	1) urgent or emergent case, 2) re-do case, 3) allergy to egg or soybean oil, 4) coronary artery disease, 5) cerebral vascular disease, 6) neurological deficits or psychiatric disorders, 7) history of drug abuse, 8) receiving current medications, 9) concurrent other surgery, 10) renal disease (serum creatinine > 2.0 mg/dL) and 11) severe hepatic disease
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	incidence of postoperative nausea and vomitting
Timepoint	at arrival to PACU (T0), after 30 min of PACU arrival (T1), after 6 hours from discharge of PACU (T2), after 24 hours from discharge of PACU (T3)
Secondary Outcome(s) 1
Outcome	evaluation of postoperative pain through VAS
Timepoint	at arrival to PACU (T0), after 30 min of PACU arrival (T1), after 6 hours from discharge of PACU (T2), after 24 hours from discharge of PACU (T3)

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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