Back to resultsA Postoperative Sore Throat After Thyroidectomy
Primary Purpose
Post Operative Sore Throat
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dexmedetomidine infusion group
remifentanil infusion group
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Sore Throat focused on measuring postoperative sore throat, dexmedetomidine, remifentanil, thyroidectomy
Eligibility Criteria
Inclusion Criteria:
- Patients who scheduled primary thyroidectomy were enrolled and their physical status was American Society of Anesthesiologists (ASA) class 1 or 2
Exclusion Criteria:
- Patients with respiratory tract disease, previous head, and neck surgery, preexisting steroid or non-steroidal anti-inflammatory drug use, and known or suspected difficult airway
Sites / Locations
- Eun kyung Choi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
dexmedetomidine infusion group
remifentanil infusion group
Arm Description
dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery
remifentanil of 4 ng/ml during induction, followed by remifentanil infusion (1.5~2.5 ng/ml) during the surgery
Outcomes
Primary Outcome Measures
incidence of postoperative sore throat at rest
0=none; 1=occur
incidence of postoperative sore throat at swallowing
0=none; 1=occur
severity of postoperative sore throat at rest
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
severity of postoperative sore throat at swallowing
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
Secondary Outcome Measures
Full Information
NCT ID
NCT03805568
First Posted
January 7, 2019
Last Updated
January 13, 2019
Sponsor
Yeungnam University College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03805568
Brief Title
A Postoperative Sore Throat After Thyroidectomy
Official Title
The Effect of Dexmedetomidine and Remifentanil on the Postoperative Sore Throat After Thyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
July 3, 2018 (Actual)
Study Completion Date
July 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study was performed to compare the effect on of a postoperative sore throat between dexmedetomidine and remifentanil in patients undergoing thyroidectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Sore Throat
Keywords
postoperative sore throat, dexmedetomidine, remifentanil, thyroidectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine infusion group
Arm Type
Active Comparator
Arm Description
dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery
Arm Title
remifentanil infusion group
Arm Type
Active Comparator
Arm Description
remifentanil of 4 ng/ml during induction, followed by remifentanil infusion (1.5~2.5 ng/ml) during the surgery
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine infusion group
Intervention Description
dexmedetomidine as anaesthetic adjuvant
Intervention Type
Drug
Intervention Name(s)
remifentanil infusion group
Intervention Description
remifentanil as anaesthetic adjuvant
Primary Outcome Measure Information:
Title
incidence of postoperative sore throat at rest
Description
0=none; 1=occur
Time Frame
6 hours after surgery
Title
incidence of postoperative sore throat at swallowing
Description
0=none; 1=occur
Time Frame
6 hours after surgery
Title
severity of postoperative sore throat at rest
Description
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
Time Frame
6 hours after surgery
Title
severity of postoperative sore throat at swallowing
Description
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
Time Frame
6 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who scheduled primary thyroidectomy were enrolled and their physical status was American Society of Anesthesiologists (ASA) class 1 or 2
Exclusion Criteria:
Patients with respiratory tract disease, previous head, and neck surgery, preexisting steroid or non-steroidal anti-inflammatory drug use, and known or suspected difficult airway
Facility Information:
Facility Name
Eun kyung Choi
City
Daegu
State/Province
Korea (the Republic Of)
ZIP/Postal Code
41944
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Postoperative Sore Throat After Thyroidectomy
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