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Effect of oxynorm on postoperative pain and recovery from anesthesia in patients undergoing thyroidectomy

Status Approved

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	KCT0001057
Unique Protocol ID	IIT-2014-035
Public/Brief Title	Effect of oxynorm on postoperative pain and recovery from anesthesia in patients undergoing thyroidectomy
Scientific Title	Effect of oxynorm on postoperative pain and recovery from anesthesia in patients undergoing thyroidectomy
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	IIT-2014-035
Approval Date	2014-03-07
Institutional Review Board Name	Inje University Seoul Paik Hospital institutional review board
Institutional Review Board Address
Institutional Review Board Telephone
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	yoon ji choi
Title	assistant professor
Telephone
Affiliation	Inje University Seoul Paik Hospital
Address
Contact Person for Public Queries
Name	yoon ji choi
Title	assistant professor
Telephone
Affiliation	Inje University Seoul Paik Hospital
Address
Contact Person for Updating Information
Name	yoon ji choi
Title	assistant professor
Telephone
Affiliation	Inje University Seoul Paik Hospital
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	Recruiting
Date of First Enrollment	2014-03-10 Actual
Target Number of Participant	120
Primary Completion Date	2014-10-16 , Anticipated
Study Completion Date	2014-12-31 , Anticipated
Name of Study	Inje University Seoul Paik Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2014-03-10 ,

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 Seoul Paik Hospital
Organization Type	Medical Institute
Project ID	IIT-2014-035

6. Sponsor Organization

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

7. Study Summary

Study Summary Information
Lay Summary	Effect of oxynorm on postoperative pain and recovery from anesthesia in patients undergoing thyroidectomy

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	Others (Effect of oxynorm on postoperative pain and recovery from anesthesia)
Phase	Phase4
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	Group L: lidocaine group. lidocaine 2 mg/kg/hr contonuous infusion with 2 mg/kg bolus Group O: oxynorm group. 0.1 mg/kg bolus when skin incision was start Group R: remifentanil group. remifentanil continuous infusion with Ce (effect site concentration) 2-5 ng/ml For the blinding, all patients were performed 1 bolus and 1 continuous infusion with study drug or saline.
Number of Arms	3
Arm 1	Arm Label Group L
	Target Number of Participant 40
	Arm Type Active comparator
	Arm Description Group L: lidocaine group. lidocaine 2 mg/kg/hr contonuous infusion with 2 mg/kg bolus
Arm 2	Arm Label Group O
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description Group O: oxynorm group. 0.1 mg/kg bolus when skin incision was start
Arm 3	Arm Label Group R
	Target Number of Participant 40
	Arm Type Active comparator
	Arm Description Group R: remifentanil group. remifentanil continuous infusion with Ce (effect site concentration) 2-5 ng/ml

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (E00-E90)Endocrine, nutritional and metabolic diseases (E07.9)Disorder of thyroid, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~65Year
	Description patients aged from 20 to 65 undergogin thyroidectomy
Exclusion Criteria	- emergency surgery - difficult intubarion - aspiration during surgery - respiratody disease/infection - smoker - chronic cough - liver/heart/ kedney 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	Efficacy
Outcome	incidence of pain after surgery
Timepoint	after surgery
Secondary Outcome(s) 1
Outcome	incidence of giving painkiller after surgery
Timepoint	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

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