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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2014/03/12
    • Registered Date : 2014/04/11
    • Last Updated Date : 2014/04/11
Background Information
1.Background  
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
 
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
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  
- Address  
- Telephone  
Data Monitoring Committee    
Contact Details
3.Contact Details  
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  
Status
4. Status Status  
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
Recruitment Status by Participating Study Site 1 
- Name of Study Site Inje University Seoul Paik Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2014-03-10 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Inje University Seoul Paik Hospital 
- Organization Type Medical Institute  
- Project ID IIT-2014-035 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Inje University Seoul Paik Hospital 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
Lay Summary Effect of oxynorm on postoperative pain and recovery from anesthesia in patients undergoing thyroidectomy  
Study Design 정보
8. Study Design  
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
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 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Not Applicable
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 20 Year ~ 65 Year
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
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
- Outcome incidence of pain after surgery 
- Timepoint after surgery 
Secondary Outcome(s) 1 
- Outcome incidence of giving painkiller after surgery 
- Timepoint after surgery 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Not provided at time of Registration