CoughingPhase 4NCT01774305
Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy
A Phase 4 study testing Dexmedetomidine and Saline in people with Coughing, run by Yonsei University at 1 site in South Korea.
Trial summary
Coughing during emergence from general anaesthesia may lead to dangerous effects including laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4% of patients, and severe coughing may cause bleeding. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coughing
- What is being tested?
- Dexmedetomidine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Jun 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status 1 or 2 patients patients scheduled for thyroidectomy
Who cannot join
- Severe cardiovascular disease history of motion sickness active status of upper respiratory infection allergy to dexmedetomidine patients who cannot understand Korean
Trial locations and contacts
1 site in 1 country.
About this study
Coughing during emergence from general anaesthesia may lead to dangerous effects including laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4% of patients, and severe coughing may cause bleeding. Dexmedetomidine, a potent α adrenoreceptor agonist, is theoretically appropriate for reducing airway and haemodynamic reflexes during emergence from anaesthesia.
In this study, we investigated whether intravenous single-dose dexmedetomidine at the end of surgery reduces coughing during extubation after thyroidectomy.
- Conditions
- Coughing
- Being tested
- Dexmedetomidine, Saline
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing.
SalineDrug
Also called Normal saline
We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing. Receives: Drug: Dexmedetomidine |
| saline | Placebo comparator | We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coughing Grade
The coughing incidence and severity will be measured at extubation. Especially from the time of eye opening to 5 min after extubation. The coughing grade was assessed by the following cough grading system: Grade 0, no cough or single, mild cough at extubation; Grade 1, multiple, not sustained cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).
Measured: from the time of eye opening to 5 min after extubation
Secondary outcomes (1)
Emergence Time
The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.
Measured: from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoughingStudies 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
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Soo Lee, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774305
- Sponsor's protocol ID
- 3-2012-0142
- Status last verified
- Jan 2014
- First submitted
- 22 Dec 2012
- Last updated
- 10 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Lee JS, Choi SH, Kang YR, Kim Y, Shim YH. Efficacy of a single dose of dexmedetomidine for cough suppression during anesthetic emergence: a randomized controlled trial. Can J Anaesth. 2015 Apr;62(4):392-8. doi: 10.1007/s12630-014-0295-6. Epub 2014 Dec 19.
PubMed 25523837
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy
- ClinicalTrials.gov ID
- NCT01774305
- Acronym / sponsor ID
- 3-2012-0142
- Conditions
- Coughing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Posted 22 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coughing during emergence from general anaesthesia may lead to dangerous effects including laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4% of patients, and severe coughing may cause bleeding. Dexmedetomidine, a potent α adrenoreceptor agonist, is theoretically appropriate for reducing airway and haemodynamic reflexes during emergence from anaesthesia.
In this study, we investigated whether intravenous single-dose dexmedetomidine at the end of surgery reduces coughing during extubation after thyroidectomy.
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: DexmedetomidineWe administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing. |
| saline | Placebo comparator | Drug: SalineWe administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status 1 or 2 patients patients scheduled for thyroidectomy
Key exclusion criteria (1 listed)
- Severe cardiovascular disease history of motion sickness active status of upper respiratory infection allergy to dexmedetomidine patients who cannot understand Korean
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexWe administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing. | Drug | dexmedetomidine |
| SalineAlso: Normal salineWe administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing. | Drug | saline |
Primary outcome
Coughing Grade
Time frame: from the time of eye opening to 5 min after extubation
The coughing incidence and severity will be measured at extubation. Especially from the time of eye opening to 5 min after extubation. The coughing grade was assessed by the following cough grading system: Grade 0, no cough or single, mild cough at extubation; Grade 1, multiple, not sustained cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).
1 secondary outcome
Emergence Time
Time frame: from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25523837Lee JS, Choi SH, Kang YR, Kim Y, Shim YH. Efficacy of a single dose of dexmedetomidine for cough suppression during anesthetic emergence: a randomized controlled trial. Can J Anaesth. 2015 Apr;62(4):392-8. doi: 10.1007/s12630-014-0295-6. Epub 2014 Dec 19.
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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 Phase 4 study testing Dexmedetomidine and Saline in people with Coughing, 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 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 10 Feb 2014. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Coughing Grade (time frame: from the time of eye opening to 5 min after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01774305, which also lists 1 linked publication.
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 10 Feb 2014.