Coughing
Conditions
Brief 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. 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.
Interventions
DRUGDexmedetomidine
We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing.
DRUGSaline
We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status 1 or 2 patients patients scheduled for thyroidectomy
Exclusion criteria
* Severe cardiovascular disease history of motion sickness active status of upper respiratory infection allergy to dexmedetomidine patients who cannot understand Korean
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coughing Grade | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergence Time | from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min) | The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command. |
Countries
South Korea
Participant flow
Recruitment details
recruitment period : Sep.2012. \ Jan. 2013 types of location : medical clinic.
Pre-assignment details
there was no specific pre-assignment details.
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing. | 70 |
| Saline We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing. | 71 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Dexmedetomidine | Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 71 Participants | 141 Participants |
| Age, Continuous | 45.3 years STANDARD_DEVIATION 10.4 | 45.6 years STANDARD_DEVIATION 12.3 | 45.5 years STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 59 Participants | 53 Participants | 112 Participants |
| Sex: Female, Male Male | 11 Participants | 18 Participants | 29 Participants |
| smoking non-smoking | 58 participants | 53 participants | 111 participants |
| smoking smoking | 12 participants | 18 participants | 30 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 71 | 0 / 71 |
| serious Total, serious adverse events | 0 / 71 | 0 / 71 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine | Coughing Grade | 0.6 units on a scale | Standard Deviation 0.9 |
| Saline | Coughing Grade | 1.4 units on a scale | Standard Deviation 0.9 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine | Emergence Time | 492 sec | Standard Deviation 176 |
| Saline | Emergence Time | 355 sec | Standard Deviation 151 |