ThyroidectomyPhase 4NCT02208505
Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion
A Phase 4 study testing Dexmedetomidine + Remifentanil-low dose and Remifentanil-high dose in people with Thyroidectomy, run by Yonsei University at 1 site in South Korea.
Trial summary
After thyroid surgery, the incidence and severity of coughing is important because it may cause serious complications, such as bleeding in the surgical field, laryngospasm, and cardiovascular disturbance. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Thyroidectomy
- What is being tested?
- Dexmedetomidine + Remifentanil-low dose and Remifentanil-high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Dec 2015
- Phase
- Phase 4
- 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
- Thyroid disease undergoing thyroidectomy
- age 20-65
- Amerian society of anesthesgiologist class 1 or 2
Who cannot join
- chronic cough
- difficult intubation
- liver disease
- uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion During Emergence in Adults After Thyroidectomy: Comparison With High-dose Remifentanil Infusion Alone
After thyroid surgery, the incidence and severity of coughing is important because it may cause serious complications, such as bleeding in the surgical field, laryngospasm, and cardiovascular disturbance. Several studies have shown that the single-dose of dexmedetomidine is effective for reducing cough and agitation during emergence from general anesthesia.
To test the hypothesis that single-dose of dexmedetomidine combined with a low-dose remifentanil infusion during emergence from general anaesthesia could reduce coughing as good as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression and reduction of side effect of remifentanil using non-inferiority trial.
- Conditions
- Thyroidectomy
- Being tested
- Dexmedetomidine + Remifentanil-low dose, Remifentanil-high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine + Remifentanil-low doseDrug
Also called Precedex
single dose administration (0.5mcg/kg) 10 min before end of the surgery with maintain the infusion of remifentanil (TCI 1 ng/ml) until end of surgery
Remifentanil-high doseDrug
Also called Ultiva
maintain the infusion of remifentanil until end of the surgery (TCI 2 ng/ml)
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | we administrate the single-dose dexmedetomidine (0.5mcg/kg) with low-dose remifentanil infusion(TCI 1 ng/ml). Receives: Drug: Dexmedetomidine + Remifentanil-low dose |
| Remifentanil | Active comparator | we administrate the high-dose remifentanil infusion(TCI 2 ng/ml) alone. Receives: Drug: Remifentanil-high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of coughing during emergence from general anesthesia
Measured: from 5min before extubation to 5min after extubation
Secondary outcomes (1)
side effect of remifentanil
comparison of the incidence of delayed awakening, post-operative nausea/vomiting, consumption of pain killer
Measured: up to 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Soo Lee, Yonsei University
- Investigators
- Jeong Soo Lee, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208505
- Sponsor's protocol ID
- 3-2013-0192'
- Status last verified
- Oct 2017
- First submitted
- 11 Feb 2014
- Last updated
- 18 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion During Emergence in Adults After Thyroidectomy: Comparison With High-dose Remifentanil Infusion Alone
- ClinicalTrials.gov ID
- NCT02208505
- Acronym / sponsor ID
- 3-2013-0192'
- Conditions
- Thyroidectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Aug 2014 (estimated)
- 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.
After thyroid surgery, the incidence and severity of coughing is important because it may cause serious complications, such as bleeding in the surgical field, laryngospasm, and cardiovascular disturbance. Several studies have shown that the single-dose of dexmedetomidine is effective for reducing cough and agitation during emergence from general anesthesia.
To test the hypothesis that single-dose of dexmedetomidine combined with a low-dose remifentanil infusion during emergence from general anaesthesia could reduce coughing as good as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression and reduction of side effect of remifentanil using non-inferiority trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine + Remifentanil-low dosewe administrate the single-dose dexmedetomidine (0.5mcg/kg) with low-dose remifentanil infusion(TCI 1 ng/ml). |
| Remifentanil | Active comparator | Drug: Remifentanil-high dosewe administrate the high-dose remifentanil infusion(TCI 2 ng/ml) alone. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Thyroid disease undergoing thyroidectomy
- age 20-65
- Amerian society of anesthesgiologist class 1 or 2
Key exclusion criteria (4 listed)
- chronic cough
- difficult intubation
- liver disease
- uncontrolled hypertension
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 + Remifentanil-low doseAlso: Precedexsingle dose administration (0.5mcg/kg) 10 min before end of the surgery with maintain the infusion of remifentanil (TCI 1 ng/ml) until end of surgery | Drug | Dexmedetomidine |
| Remifentanil-high doseAlso: Ultivamaintain the infusion of remifentanil until end of the surgery (TCI 2 ng/ml) | Drug | Remifentanil |
Primary outcome
Incidence of coughing during emergence from general anesthesia
Time frame: from 5min before extubation to 5min after extubation
1 secondary outcome
side effect of remifentanil
Time frame: up to 1 day after surgery
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 18 Oct 2017.
Related trials for Thyroidectomy
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NIRAF-Guided Parathyroid Identification During Thyroidectomy
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Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
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Comparison of Post-operative Outcomes Between ERAS Protocol and Non-ERAS Local Regimen in Patients Undergoing Thyroidectomy
Thyroid Diseases, Ambulation Time
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
RecruitingPhase 4
Remifentanil Versus Remifentanil-Lidocaine for Tracheal Extubation After Thyroidectomy
Tracheal Extubation, Cough
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.
Jeong Soo Lee principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine + Remifentanil-low dose and Remifentanil-high dose in people with Thyroidectomy, run by Yonsei University 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 3 inclusion and 4 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 18 Oct 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 coughing during emergence from general anesthesia (time frame: from 5min before extubation to 5min after extubation). 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 18 Oct 2017.