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Comparison of the postoperative pain intensity and complications following different anesthetic techniques during thyroidectomy

Status Approved

First Submitted Date

2020/05/20
Registered Date

2020/05/21
Last Updated Date

2020/05/21

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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	KCT0005047
Unique Protocol ID	2016-0463
Public/Brief Title	Comparison of the postoperative pain intensity and complications following different anesthetic techniques during thyroidectomy
Scientific Title	Comparison of the postoperative pain intensity and complications following different anesthetic techniques during thyroidectomy
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	2016-0463
Approval Date	2016-05-04
Institutional Review Board Name	the Institutional Review Board of Asan Medical Center
Institutional Review Board Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Institutional Review Board Telephone	02-3010-7166
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	Seung-Woo Ku
Title	Professor
Telephone	+82-2-3010-3868
Affiliation	Asan Medical Center
Address	88 Olympic-ro 43 gil, Sonpa-gu, Seoul
Contact Person for Public Queries
Name	Jun-Young Jo
Title	Assistant Professor
Telephone	+82-2-3010-3868
Affiliation	Asan Medical Center
Address	88 Olympic-ro 43 gil, Sonpa-gu, Seoul
Contact Person for Updating Information
Name	Jun-Young Jo
Title	Assistant Professor
Telephone	+82-2-3010-3868
Affiliation	Asan Medical Center
Address	88 Olympic-ro 43 gil, Sonpa-gu, Seoul

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	2016-05-13 Actual
Target Number of Participant	80
Primary Completion Date	2016-11-18 , Actual
Study Completion Date	2017-04-24 , Actual
Name of Study	Asan Medical Center
Recruitment Status	Completed
Date of First Enrollment	2016-05-13 ,

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	Asan Medical Center
Organization Type	Medical Institute
Project ID	2016-0463

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Asan Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Continuous remifentanil infusion during general anesthesia effectively and easily maintains vitals. However, high pain levels and increased demand for postoperative analgesics in the early postoperative period are often encountered. This study investigated pain intensity and the need for rescue analgesics in the immediate postoperative period in patients after total intravenous anesthesia with remifentanil compared with intravenous induction and volatile maintenance anesthesia.

Study Summary Information

Lay Summary

Continuous remifentanil infusion during general anesthesia effectively and easily maintains vitals. However, high pain levels and increased demand for postoperative analgesics in the early postoperative period are often encountered. This study investigated pain intensity and the need for rescue analgesics in the immediate postoperative period in patients after total intravenous anesthesia with remifentanil compared with intravenous induction and volatile maintenance anesthesia.

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	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Subject, Outcome Accessor
Allocation	RCT
Intervention Type	Others
Intervention Description	Each patient was randomly assigned to the TIVA (total intravenous anesthesia) or VA (volatile anesthesia) group.
Number of Arms	2
Arm 1	Arm Label volatile anesthesia
	Target Number of Participant 40
	Arm Type Active comparator
	Arm Description Maintain anesthesia using only inhaled anesthetic agents without remifentanil infusion after induction of general anesthesia.
Arm 2	Arm Label total intravenous anesthsia
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description After general anesthesia is induced, general anesthesia is maintained by intravenous anesthesia using propofol and remifentanil. Remifentanil is infused by target-controlled infusion method and remifentanil was titrated to maintain the patient’s baseline blood pressure within 20%.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (E00-E90)Endocrine, nutritional and metabolic diseases (E07.9)Disorder of thyroid, unspecified thyroid disease which needs thyroidectomy
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~79Year
	Description We included patients from 20–79 years of age with American Society of Anesthesiologists physical status I-III and who were undergoing elective thyroid surgery by the same surgeon.
Exclusion Criteria	history of allergy or contraindication to opioids or non-steroidal anti-inflammatory agents (NSAIDs); severe renal dysfunction with limited use of NSAIDs; bronchial asthma; psychiatric disease; intake of opioids within 1 month before surgery or any analgesics 6 hours before surgery; reoperation on thyroid; or simultaneous radical neck lymph node dissection or other surgeries.
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	Not applicable
Outcome	the intensity of postoperative pain
Timepoint	arrival to post-anesthetic care unit, 30 min after surgery, and 60 min after surgery
Secondary Outcome(s) 1
Outcome	Morphine equianalgesic doses (MED)
Timepoint	during stay at post-anesthetic care unit
Secondary Outcome(s) 2
Outcome	changes of vital sign during surgery
Timepoint	induction of anesthesia to skin incision

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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