Post Operative Sore ThroatNCT03805568
A Postoperative Sore Throat After Thyroidectomy
A study testing dexmedetomidine infusion group and remifentanil infusion group in people with Post Operative Sore Throat, run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial summary
This study was performed to compare the effect on of a postoperative sore throat between dexmedetomidine and remifentanil in patients undergoing thyroidectomy. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Post Operative Sore Throat
- What is being tested?
- dexmedetomidine infusion group and remifentanil infusion group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jul 2017to 25 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who scheduled primary thyroidectomy were enrolled and their physical status was American Society of Anesthesiologists (ASA) class 1 or 2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dexmedetomidine and Remifentanil on the Postoperative Sore Throat After Thyroidectomy
This study was performed to compare the effect on of a postoperative sore throat between dexmedetomidine and remifentanil in patients undergoing thyroidectomy.
- Conditions
- Post Operative Sore Throat
- Being tested
- dexmedetomidine infusion group, remifentanil infusion group
- Keywords
- postoperative sore throat, dexmedetomidine, remifentanil, thyroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine infusion groupDrug
dexmedetomidine as anaesthetic adjuvant
remifentanil infusion groupDrug
remifentanil as anaesthetic adjuvant
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine infusion group | Active comparator | dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery Receives: Drug: dexmedetomidine infusion group |
| remifentanil infusion group | Active comparator | remifentanil of 4 ng/ml during induction, followed by remifentanil infusion (1.5~2.5 ng/ml) during the surgery Receives: Drug: remifentanil infusion group |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative sore throat at rest
0=none; 1=occur
Measured: 6 hours after surgery
incidence of postoperative sore throat at swallowing
0=none; 1=occur
Measured: 6 hours after surgery
severity of postoperative sore throat at rest
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
Measured: 6 hours after surgery
severity of postoperative sore throat at swallowing
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
Measured: 6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start5 Jul 2017
- Primary completion3 Jul 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Kyung Choi, Yeungnam University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805568
- Sponsor's protocol ID
- YUMC 2017-03-037
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 15 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine and Remifentanil on the Postoperative Sore Throat After Thyroidectomy
- ClinicalTrials.gov ID
- NCT03805568
- Acronym / sponsor ID
- YUMC 2017-03-037
- Conditions
- Post Operative Sore Throat
- Keywords
- postoperative sore throat, dexmedetomidine, remifentanil, thyroidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was performed to compare the effect on of a postoperative sore throat between dexmedetomidine and remifentanil in patients undergoing thyroidectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine infusion group | Active comparator | Drug: dexmedetomidine infusion groupdexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery |
| remifentanil infusion group | Active comparator | Drug: remifentanil infusion groupremifentanil of 4 ng/ml during induction, followed by remifentanil infusion (1.5~2.5 ng/ml) during the surgery |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who scheduled primary thyroidectomy were enrolled and their physical status was American Society of Anesthesiologists (ASA) class 1 or 2
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidine infusion groupdexmedetomidine as anaesthetic adjuvant | Drug | dexmedetomidine infusion group |
| remifentanil infusion groupremifentanil as anaesthetic adjuvant | Drug | remifentanil infusion group |
Primary outcome
incidence of postoperative sore throat at rest
Time frame: 6 hours after surgery
0=none; 1=occur
incidence of postoperative sore throat at swallowing
Time frame: 6 hours after surgery
0=none; 1=occur
severity of postoperative sore throat at rest
Time frame: 6 hours after surgery
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
severity of postoperative sore throat at swallowing
Time frame: 6 hours after surgery
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: Yes
Related trials for Post Operative Sore Throat
Not yet recruitingPhase 2
A Randomized Controlled Trial Evaluating the Efficacy of Soaking Endotracheal Tube in Dexamethasone Solution for Prevention of Postoperative Sore Throat After Laparoscopic Cholecystectomy
Post Operative Sore Throat
Active, not recruiting
Efficacy of Flurbiprofen Spray for Postoperative Sore Throat Following Double-Lumen Endobronchial Intubation
Post Operative Sore Throat, Hoarseness
Not yet recruitingPhase 1/2
Comparison of Efficacy of Betamethasone Gel With Lidocaine Gel in Prevention of Post Endotracheal Intubation Sore Throat.
Post Operative Sore Throat at 6hrs and 24hrs After Endotracheal Intubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine infusion group and remifentanil infusion group in people with Post Operative Sore Throat, run by Yeungnam University College of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative sore throat at rest (time frame: 6 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019; AzTrials last refreshed its copy on 27 Oct 2026.