A Dose - Dependent Study of Dexmedetomidine in Suppressing Cardiovascular and Hormonal Responses for Cesarean Delivery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- identifying the effects of 0.2, 0.4 and 0.6 µg/kg/h dexmedetomidine for on 1. Hemodynamic [heart rate, systolic and mean blood pressure] changes. 2. The perioperative changes in plasma cortisol and catecholamines concentrations
研究概览
简要总结
Regional anesthesia has become the anesthetic of choice for cesarean section in most countries; however, some women still prefer general anesthesia techniques. There are many trials for the pharmacological modifications of the sympathetic response to surgery, including opioids, tenoxicam, ketorolac, lidocaine and paracetamol. However, opioid administration to the mother before delivery has adverse neonatal effects. This research is a novel trial on the use of dexmedetomidine for suppression of the hemodynamic and hormonal responses of cesarean delivery.
详细描述
Literature Review Regional anesthesia has become the anesthetic of choice for cesarean section in most countries; however, some women still prefer general anesthesia rather than regional techniques. There are many published controlled trials for the pharmacological modifications of the sympathetic response to laryngoscopy, tracheal intubation, and surgical stimulation, including opioids, tenoxicam, ketorolac, lidocaine and paracetamol.1-6 However, opioid administration to the mother before delivery has adverse neonatal respiratory depression.1
Dexmedetomidine, a specific [alpha]2-adrenoceptor agonist, has been approved for clinical use for sedation of patients who need mechanical ventilation in the intensive care unit. 7 It has shown sedative, analgesic, and anxiolytic effects after intravenous (IV) administration.8It is felt that the sedative effect of dexmedetomidine is safe and suited for extubation under sedation because it has little effect on respiration.9
An older study tested the effects of preoperative administration of dexmedetomidine 10 min prior to the induction of anesthesia on hemodynamic changes after intubation in 96 women undergoing abdominal hysterectomy. They found that the increase in blood pressure and heart rate was significantly less in the higher dexmedetomidine (0.6 µg/kg) group than in the saline group (P < 0.01). Also, the postintubation increase in heart rate was significantly less (P < 0.05) with the use of dexmedetomidine 0.6 µg/kg (increase of 18 ± 3 bpm) compared to fentanyl (increase of 26 ± 3 bpm). In patients receiving dexmedetomidine 0.3 µg/kg, the increase in blood pressure or heart rate did not differ from those receiving saline.10
Others found that a single pre-induction intravenous dose of dexmedetomidine 2 µg/kg in 50 patients undergoing minor orthopaedic and general surgery was associated with reduced the hemodynamic response to tracheal intubation and extubation, intra-operative heart rate variability, postoperative analgesic and anti-emetic requirements and lower peri-operative serum catecholamine concentrations. However, there were more frequent episodes of hypotension and bradycardia.11
Similarly, others reported that preoperative administration of a single dose of dexmedetomidine 50 patients scheduled for elective minor surgery resulted in progressive increases in sedation, blunted the haemodynamic responses during laryngoscopy, and reduced opioid and anaesthetic requirements. 12
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •80 women aged 18-45 years (ASA physical status II-III)with uncomplicated, singleton pregnancies of at least 36 weeks' gestation scheduled for elective cesarean delivery under general anesthesia.
排除标准
- •women with a history of cardiac, liver, or kidney diseases;
- •women with allergy to amide local anesthetics;
- •women with epilepsy;
- •those taking cardiovascular medications;
- •those with pregnancy-induced hypertension;
- •women with evidence of intrauterine growth restriction or fetal compromise.
研究组 & 干预措施
Dexmedetomidine 0.6 µg/kg/h
The dexmedetomidine group will receive i.v. infusion of 0.1 mL/kg/h of solution containing 6 µg/mL of dexmedetomidine, at 20 min before induction of anesthesia
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 0.4 µg/kg/h
The dexmedetomidine group will receive i.v. infusion of 0.1 mL/kg/h of solution containing 4 µg/mL of dexmedetomidine, at 20 min before induction of anesthesia
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 0.2 µg/kg/h
The dexmedetomidine group will receive i.v. infusion of 0.1 mL/kg/h of solution containing 2 µg/mL of dexmedetomidine, at 20 min before induction of anesthesia.
干预措施: Dexmedetomidine (Drug)
Placebo
The placebo group (n = 20) will receive an i.v. infusion of 0.1 mL/kg/h saline 0.9%, at 20 min before induction of anesthesia
干预措施: Placebo (Drug)
结局指标
主要结局
identifying the effects of 0.2, 0.4 and 0.6 µg/kg/h dexmedetomidine for on 1. Hemodynamic [heart rate, systolic and mean blood pressure] changes. 2. The perioperative changes in plasma cortisol and catecholamines concentrations
时间窗: before and 15 min after infusion; each 1 min for 10 min after induction; 15 and 30 min after delivery; and 0, 1, 5, 15, 30, and 60 min after extubation
次要结局
- Apgar score, the neurologic and adaptive capacity score (NACS), and umbilical cord venous and arterial blood gases analyses.The quality of extubation and analgesia.major complications (respiratory, cardiovascular events, and neonatal adverse outcome(after delivery, and postoperative)