Efficacy of Dexmedetomidine for Cough Suppression During Anesthetic Emergence in Patients Undergoing Thyroid Surgery: A Randomized, Double Blinded, Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Incidence of coughing during anesthetic emergence
研究概览
简要总结
Maintenance of a remifentanil infusion during anesthetic emergence has been reported to decrease the incidence of coughing and thereby help to ensure a smooth emergence. It may, however, cause respiratory depression and possibly delay emergence. The purpose of this study was to investigate the effect of different dose of dexmedetomidine infusion on cough suppression during emergence from general anesthesia in patients undergoing thyroid surgery.
American Society of Anesthesiologists physical status I-II adults undergoing elective thyroidectomy under general anesthesia are recruited and randomly allocated to receive dexmedetomidine iv infusion of 0.2μg·kg-1·h-1 (Group D1, n = 100), 0.5μg·kg-1·h-1 (Group D2, n = 100), 0.7μg·kg-1·h-1 (Group D3, n = 100) or saline (Group C, n = 100). Primary outcome is the incidence of coughing during emergence. Second outcomes include severity of coughing, which is assessed using a four-point scale; Ramsay score, Bruggrmann comfort scale score, VAS pain score are recorded. The respiratory rate (RR), heart rate (HR), and mean arterial pressure are also recorded.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30Kg/m2 ≥ BMI > 18Kg/m2;
- •undergoing general anesthesia;
- •ASA physical status I and II
- •undergoing elective thyroid surgery.
排除标准
- •hyperthyroidism;
- •preoperative bradycardia;
- •liver function impairment;
- •renal function impairment;
- •heart function failure;
- •history of asthma or COPD;
- •history of diabetes;
- •cognition function impairment;
- •pregnant or lactating women
研究组 & 干预措施
Dexmedetomidine low dose group
Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.2μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery
干预措施: Dexmedetomidine Hydrochloride (Drug)
Dexmedetomidine median dose group
Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.5μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery
干预措施: Dexmedetomidine Hydrochloride (Drug)
Dexmedetomidine high dose group
Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.7μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery
干预措施: Dexmedetomidine Hydrochloride (Drug)
Control group (normal saline group)
Patients in this group are received saline iv infusion of 5mL·h-1 from incision to 20-30 minutes before the end of surgery
干预措施: Normal Saline (Drug)
结局指标
主要结局
Incidence of coughing during anesthetic emergence
时间窗: within 10 minutes after endotracheal extubation
incidence of coughing within 10 minutes after extubation
次要结局
- Ccoughing on a four-point scale during anesthetic emergence(within 10 minutes after endotracheal extubation)
- Ramsay score during anesthetic emergence(within 30 minutes after endotracheal extubation)
- VAS pain score(within 48 hrs after endotracheal extubation)
- Respiratory rate (RR)(within 30min after endotracheal extubation)
- Heart rate(within 30 minutes after endotracheal extubation)
- mean arterial pressure(within 30 minutes after endotracheal extubation)
- Bruggrmann comfort scale score(within 24 hrs after endotracheal extubation)
研究者
Min Su
clinical professor
First Affiliated Hospital of Chongqing Medical University