Effect of Perioperative Dexmedetomidine Infusion on Anesthetic Requirements and Quality of Emergence in Patients Undergoing Thyroid Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Coughing During Extubation
研究概览
简要总结
Thyroid surgery requires smooth emergence from anesthesia to minimize coughing, hemodynamic fluctuations, and agitation during extubation, which may contribute to postoperative complications such as bleeding or cervical hematoma. Dexmedetomidine, a selective α2-adrenergic receptor agonist, has sedative, analgesic-sparing, and sympatholytic properties that may improve anesthetic stability and recovery quality.
This randomized controlled trial aims to evaluate the effectiveness of a continuous perioperative dexmedetomidine regimen initiated at induction of anesthesia and maintained during thyroid surgery.
The study will compare dexmedetomidine combined with standard balanced anesthesia versus standard anesthesia alone in terms of anesthetic requirements and emergence quality.
The primary hypothesis is that perioperative dexmedetomidine administration reduces anesthetic and opioid requirements and improves emergence quality by decreasing coughing during extubation and hemodynamic responses.
详细描述
Dexmedetomidine has been widely studied as an anesthetic adjunct due to its sedative and analgesic-sparing effects without significant respiratory depression. Previous randomized trials have demonstrated its ability to reduce coughing during extubation, attenuate sympathetic responses, and improve recovery quality after thyroid surgery. However, most studies have administered dexmedetomidine only during emergence or intraoperatively.
This study investigates a comprehensive perioperative dexmedetomidine protocol consisting of:
- A loading dose immediately before induction of anesthesia
- Continuous infusion during surgery The aim is to assess whether this regimen improves intraoperative anesthetic efficiency and postoperative recovery quality.
Patients scheduled for thyroid surgery under general anesthesia will be randomized to receive dexmedetomidine or standard anesthesia without dexmedetomidine. Standardized anesthetic techniques will be used for induction, maintenance, and postoperative care.
Outcome measures include anesthetic requirements, opioid consumption, coughing at extubation, emergence agitation, hemodynamic responses, postoperative nausea and vomiting (PONV), and postoperative bleeding complications.
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)
盲法说明
Double-blind (Participant, Outcome 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
- •Age 18-65 years.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Scheduled for elective thyroid surgery (thyroidectomy) under general anesthesia with endotracheal intubation.
- •Able to understand the study procedures and provide written informed consent.
排除标准
- •Known hypersensitivity or contraindication to dexmedetomidine or study-related medications.
- •Clinically significant cardiac conduction abnormality or arrhythmia (e.g., second- or third-degree atrioventricular block without a pacemaker), severe bradyarrhythmia, or unstable cardiovascular disease.
- •Severe hepatic dysfunction or severe renal failure.
- •Pregnancy or breastfeeding.
- •Planned postoperative ICU admission or postoperative deterioration requiring ICU admission.
- •Major intraoperative complications (e.g., major bleeding requiring urgent hemostatic intervention, tracheal or esophageal injury, or recurrent laryngeal nerve injury identified intraoperatively).
- •Any condition that, in the investigator's judgment, would interfere with outcome assessment or increase risk (e.g., inability to reliably report pain scores or complete QoR-15).
研究组 & 干预措施
Dexmedetomidine Group
Participants receive dexmedetomidine in addition to standardized general anesthesia. Dexmedetomidine is administered as a loading dose of 1 µg/kg during induction of anesthesia (in 10 minutes), followed by continuous infusion at 0.5 µg/kg/h throughout surgery.
干预措施: Standard General Anesthesia (Procedure)
Standard Anesthesia (Control Group)
Participants receive standardized general anesthesia without dexmedetomidine. Anesthesia is induced with propofol, opioid analgesia, and neuromuscular blockade, and maintained using inhalational anesthetic agents according to institutional practice.
干预措施: Standard General Anesthesia (Procedure)
Dexmedetomidine Group
Participants receive dexmedetomidine in addition to standardized general anesthesia. Dexmedetomidine is administered as a loading dose of 1 µg/kg during induction of anesthesia (in 10 minutes), followed by continuous infusion at 0.5 µg/kg/h throughout surgery.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Incidence and Severity of Coughing During Extubation
时间窗: From suctioning of airway secretions until 5 minutes after extubation
Coughing during emergence will be assessed using a standardized cough grading scale: * Grade 0: No cough * Grade 1: Single cough * Grade 2: Cough lasting ≤5 seconds * Grade 3: Sustained cough \>5 seconds or severe coughing The incidence and severity of cough will be recorded.
Total Intraoperative Anesthetic Requirement
时间窗: During surgery
Total dose of anesthetic agents used during maintenance of anesthesia will be recorded, including: Volatile anesthetic concentration (MAC equivalents)
次要结局
- Propofol consumption for induction(During induction)
- Total Intraoperative Opioid Consumption(During surgery)
- Emergence Agitation(During emergence and within the first 15 minutes in the PACU.)
- Postoperative Bleeding or Cervical Hematoma(Within 24 hours after surgery)
- Mean arterial pressure (mmHg)(From induction to 10 minutes after extubation.)
- Heart rate (beats per minute)(From induction to 10 minutes after extubation.)
- Postoperative Pain Intensity(PACU arrival; 1 hour; 6 hours; 12 hours; and 24 hours postoperatively.)
- Postoperative Nausea and Vomiting (PONV)(Within 24 hours after surgery)
- Postoperative Recovery Quality(24 hours after surgery)
研究者
Nguyen Toan Thang
Consultant Anesthesiologist
Bach Mai Hospital