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
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- the incidence of coughing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Anticipated difficult airway
研究组 & 干预措施
D group (dexmedetomidine)
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.
干预措施: Dexmeditomidine (Drug)
C group (saline)
The patients received equal volume normal saline by intravenous infusion at the beginning of the surgery,and continued till end of surgery.
干预措施: normal saline (Drug)
结局指标
主要结局
the incidence of coughing
时间窗: within 48 hours postoperatively
coughing will be observed
次要结局
- the time of extubation(within 48 hours postoperatively)
- visual analogue scale (VAS)(at 30 minutes after extubation)
- coughing on a four-point scale(within 48 hours postoperatively)
- the eyes opening time(within 48 hours postoperatively)
- sedation-agitation scale(SAS)(at 30 minutes after extubation)
研究者
Min Su
The Department of Anesthesia and Pain Medicine
First Affiliated Hospital of Chongqing Medical University