Effects of Dexmedetomidine on Cough Response and Postoperative Recovery Quality in Patients Undergoing Thyroid Surgery With General Anesthesia

Study Overview
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Brief Summary
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Coughing is a common adverse reaction of thyroid surgery,which could result in postoperative bleeding.Postoperative bleeding is a serious and potentially life-threatening complication，which could result in acute upper airway obstruction due to neck hematoma and increase the need for re-operation.The purpose of this study is to investigate whether dexmedetomidine can reduce the incidence of postoperative coughing and contribute to postoperative recovery in patients undergoing tyroid surgery with general anesthesia.

Detailed Description
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Thyroid surgery is a common clinical surgery,the incidence of postoperative coughing is up to 32.4%.Coughing response could result in postoperative bleeding,even cause respiratory tract obstruction,affect patients' postoperative recovery .Dexmedetomidine,an α2 adrenergic agonist,has hypnotic,analgesic, anxiolytic,antisympathetic effects,which could facilitate the sedation of patients while maintaining their consciousness and keep respiration and circulation stable .For these benefits,dexmedetomidine was widely used for general anesthesia.However,whether dexmedetomidine can reduce the incidence of postoperative coughing is unclear.Therefore,the investigators conduct this randomized controlled double-blind trial,to investigate the effects of dexmedetomidine on coughing and postoperative recovery quality in patients undergoing tyroid surgery with general anesthesia.

Official Title
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Effects of Dexmedetomidine on Cough Response and Postoperative Recovery Quality in Patients Undergoing Thyroid Surgery With General anesthesia---a Randomized Control Double-Blind Clinical Trial

Conditions
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Coughing Response, Thyroid Surgery, General Anesthesia

Intervention / Treatment
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* Drug: Dexmeditomidine
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 18 to 65 years old American Society of Anesthesiologists (ASA) physical statusⅠor Ⅱ Diagnosed by B ultrasonic or tissue biopsy show that patients thyrophyma,thyroid cancer,thyroid nodule,etc,who need to accept thyroid surgery Exclusion Criteria: large goiter or hyperthyroidism Preoperative coughing caused by primary diseases of patients Ⅱdegrees above atrioventricular block Allergy to anesthesia History of diabetes Pregnant women Serious mental disease History of alcohol or drug abuse Severe heart renal or liver dysfunction The presence of an upper respiratory infection Asthma Anticipated difficult airway

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D group (dexmedetomidine)<br>Dexmeditomidine 0.2 ug/kg·h will be administered to participants by intravenous infusion with microperfusion pump at the beginning of the surgery,and continued till end of surgery. | Drug: Dexmeditomidine<br>* Dexmeditomidine 0.2 ug/kg·h will be administered to participants by intravenous infusion at the beginning of the surgery,and continued till end of surgery.<br>|
| Active Comparator: C group (saline)<br>The patients received equal volume normal saline by intravenous infusion at the beginning of the surgery,and continued till end of surgery. | Drug: normal saline<br>* Isovolumetric normal saline will be administered to participants by intravenous infusion at the beginning of the surgery,and continued till end of surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of coughing | coughing will be observed | within 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coughing on a four-point scale | coughing on a four-point scale will be measured within 48 hours postoperatively | within 48 hours postoperatively | 
| the eyes opening time | the eyes opening time will be observed | within 48 hours postoperatively | 
| the time of extubation | the time of extubation will be recorded | within 48 hours postoperatively | 
| visual analogue scale (VAS) | visual analogue scale will be measured at 30 minutes after extubation | at 30 minutes after extubation | 
| sedation-agitation scale(SAS) | sedation-agitation scale will be measured at 30 minutes after extubation | at 30 minutes after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Coughing Response, Postoperative Recovery Quality, Thyroid Surgery