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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine | Experimental | We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing. |
|
| saline | Placebo Comparator | We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | from the time of eye opening to 5 min after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Emergence Time | The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command. | from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam severance hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25523837 | Derived | 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. |
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there was no specific pre-assignment details.
recruitment period : Sep.2012. ~ Jan. 2013 types of location : medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine | We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing. |
| FG001 | Saline | We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A patient in group Dexmedetomidine was not completed this study due to changed surgery plan. (Intubated time prolonged more than 3 hours)
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine | We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing. |
| BG001 | Saline | We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | from the time of eye opening to 5 min after extubation |
|
3 hours
prolonged intubation more than 3 hrs, due to changed surgical plan.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine | We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| prolonged intubation | Surgical and medical procedures | Non-systematic Assessment | 1 patient in Dex group was intubated more than 3 hrs due to changed surgical plan. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeongsoo Lee | Yonsei Univ. Health System, Gangnam Severance Hospital | +82-2-2019-6092 | ration99@yuhs.ac |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Saline | Drug | We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| smoking | It has been known that smoking history is related to coughing. | Number | participants |
|
We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
|
|
| Secondary | Emergence Time | The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command. | Posted | Mean | Standard Deviation | sec | from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min) |
|
|
|
| 0 |
| 71 |
| 1 |
| 71 |
| EG001 | Saline | We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing. | 0 | 71 | 0 | 71 |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |