Safety and Efficacy of Dexmedetomidine in Controlling Hemodynamics During Resection of Active Thyroid Secreting Tumors, A Randomized Multicentric Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Intraoperative hemodynamics
研究概览
简要总结
Experienced anesthesiologists often attempt to anticipate and blunt the hypertensive responses seen in varying degrees at critical moments of surgical stimulation. Additionally, it may take a long time to treat acute intraoperative hypertension using anesthetics, and there may be a subsequent period of hypotension due to over-compensation. Most practicing anesthesiologists rely on antihypertensive drugs for the rapid control of elevated arterial blood pressure, when volatile anesthetics and narcotics need to be discontinued for awakening. Relatively high doses of antihypertensive drugs, such as labetalol, nicardipine, or esmolol, are commonly used, regardless of the anesthetic technique.One of the main methods to control arterial blood pressure intraoperatively, was to use a typical antihypertensive regimen on an as-needed basis as well as common methods; adjustments in the concentration of volatile anesthetic.
详细描述
Thyroidectomy is the commonest endocrine surgical procedure being carried out throughout the globe. It is performed for thyroid cancer, solitary thyroid nodules, and autoimmune thyroid disease. The challenging scenarios can be encountered at any stage during thyroidectomy, be it preoperative, intraop or postoperative period .
Anesthesia for thyroid surgery may be complicated by difficult airways due to an enlarged thyroid mass and hemodynamic fluctuations due to thyroid hormone secretion . Cardiac complications are equally challenging as also the presence of various co-morbidities which make the task of anesthesiologist extremely difficult. Thyroid storm can occur during intra-op and post-op period in inadequately prepared surgical patients. The complexity of surgical intervention also adds to these existing challenges. Moreover, there always exists a potential risk of uncontrolled hemorrhage from a vascular injury.
Airway management is important during thyroid surgery. The time from induction of anesthesia and subsequent loss of consciousness to endotracheal intubation is one of the most important stages of anesthesia because of acute and dramatic changes occur in the cardiovascular and respiratory system. Direct laryngoscopy and tracheal intubation potentially increase sympathetic response. Significant increases in plasma adrenaline and noradrenaline levels have been reported within the first five minutes after intubation, which then return to preinduction values.
As a result, tachycardia, hypertension and cardiac arrhythmias may frequently, and hypotension and bradycardia may rarely be encountered. The main reason for the sympathoadrenal response to endotracheal intubation is the stimulation of the supraglottic region. Hemo-dynamic changes begin with laryngoscopy, reach a maximum level within 1-2 minutes, and return to pre-laryngoscopy values after approximately five minutes. While these transient hemodynamic responses do not cause significant problems in healthy individuals, they may have negative consequences in risky cases.
So, a greater focus is required for hemodynamic instability induced by thyroid hormone-secreting tumors or hyperthyroidism. This patient experienced intraoperative hemodynamic instability while manipulating the thyroid mass, which is not typically associated with thyroidectomy except in cases of thyroid storm, which is an acute, severe hypermetabolic state caused by excessive thyroid hormone release or increased adrenal activity. Because of the huge size of the thyroid mass, these abrupt hemodynamic changes during thyroid manipulation can be attributed to carotid baroreceptor baroreflex.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients subjected to thyroid resection surgeries for active thyroid tumors.
- •The enrolled age will be from 20 years to 65 years
- •ASA, I-III and NYHA, I-II.
排除标准
- •ASA physical status >III and NYHA >II,
- •body mass index >40 kg/m2,
- •pregnant women,
- •preoperative opioid consumption,
- •Allergy to dexmedetomidine
- •Contraindications as hypotension or cardiovascular compromise
- •Unwilling to participate in the study
研究组 & 干预措施
labetalol Group (Control group)
where patients will receive an initial bolus dose of labetalol 20 mg by slow IV injection over a 2-minute period before surgical incision to achieve target hemodynamics. Additional injections of 40 to 80 mg can be given on demand at 10-minute intervals until a desired supine blood pressure is achieved or a total of 300 mg has been used then continuous infusion of diluted labetalol solution will be administered at a rate of 2 mL/min to deliver 2 mg/min to control BP swings intraoperatively.
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
Dexmedetomidine group (Active Group);
where patients will receive an iv-bolus dose of 0.5-1 μg/kg of dexmedetomidine over 10 min before surgical incision followed by IV infusion of 0.2 - 0.7 μg/kg/h to control BP intraoperatively.
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
结局指标
主要结局
Intraoperative hemodynamics
时间窗: 5 hours intraoperatively
mean blood pressure values
次要结局
- Intensity of pain(24 hours postoperatively)
- Sedation:(24 hours postoperatively)
研究者
Mohammed Farghaly Abd El hamid Ahmed
lecturer of anaesthesia and icu
South Egypt Cancer Institute