A Phase 4 interventional study of Dexmedetomidine and Saline in Coughing, sponsored by Yonsei University. Completed at 1 site in South Korea. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-02-10.
Sponsored by Yonsei University · Phase 4, Interventional, and Prevention
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.
355 studies on the registry are indexed under Cough; 71 are open to participants now.
This study's enrollment of 141 is above the median of 71 across 270 interventional studies indexed under Cough.
Browse Cough studies →Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
Drug: Dexmedetomidine
We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
Drug: Saline
We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing.
Also known as: Precedex
We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.
Also known as: Normal saline
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).
Time frame: from the time of eye opening to 5 min after extubation
Emergence Time
The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.
Time frame: from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min)
recruitment period : Sep.2012. \~ Jan. 2013 types of location : medical clinic.
| Milestone | Dexmedetomidine | Saline |
|---|---|---|
| Started | 71 | 71 |
| Completed | 70 | 71 |
| Not completed | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
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).
| units on a scale | Dexmedetomidine | Saline |
|---|---|---|
| Coughing Grade | 0.6 ± 0.9 | 1.4 ± 0.9 |
The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.
| sec | Dexmedetomidine | Saline |
|---|---|---|
| Emergence Time | 492 ± 176 | 355 ± 151 |
Collected over 3 hours. Non-serious events are listed at a 1.4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexmedetomidine | — | 0/71 (0%) | 1/71 (1.4%) |
| Saline | — | 0/71 (0%) | 0/71 (0%) |
| Event | Dexmedetomidine | Saline |
|---|---|---|
| prolonged intubationSurgical and medical procedures | 1/71 | 0/71 |
A patient in group Dexmedetomidine was not completed this study due to changed surgery plan. (Intubated time prolonged more than 3 hours)
| Age, Categorical(Participants) | Dexmedetomidine | Saline | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 70 | 71 | 141 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Dexmedetomidine | Saline | Total |
|---|---|---|---|
| Mean | 45.3 ± 10.4 | 45.6 ± 12.3 | 45.5 ± 11.3 |
| Sex: Female, Male(Participants) | Dexmedetomidine | Saline | Total |
|---|---|---|---|
| Female | 59 | 53 | 112 |
| Male | 11 | 18 | 29 |
| smoking(participants) | Dexmedetomidine | Saline | Total |
|---|---|---|---|
| smoking | 12 | 18 | 30 |
| non-smoking | 58 | 53 | 111 |
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dexmedetomidine