Comparative Evaluation The Effect of Intraoperative Infusion of Dexmedetomidine Versus Low Dose Ketamine on Pain and Inflammatory Biomarkers in Patients Undergoing Nasal Surgery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The postoperative pain
研究概览
简要总结
Comparing between dexmedetomidine versus low dose ketamine infusion in patients undergoing nasal and paranasal sinus surgery as regard, intraoperative hemodynamic stability, blood loss, perioperative opioid requirements, Stress response evaluation through the measurement of serum level of cortisol, IL-6, blood glucose and CRP.
详细描述
The primary objective of anesthesia is balancing the patient's hemodynamics with the best possible surgical outcome. In modern anesthesia, a multimodal approach to balanced anesthesia is targeted with combined general anesthetics and systemic drugs.
Trans-nasal endoscopic surgery (TNES) is a helpful diagnostic and therapeutic modality in paranasal sinus diseases. TNES are associated with significant intraoperative bleeding, pain, epistaxis, and transient headaches .
Intra-operative surgical site bleeding is one major complication and all anesthetic techniques pursue the objective to reduce it to achieve better precision, reduced operative time, and faster postoperative wound healing.
Topical medications, surgical positioning, nasal packing, inhalational anesthetics, and systemic drugs are some of the documented methods.
Controlled hypotension is one of the methods to control bleeding. It reduces blood loss, enhances the operative field quality (dryness) and studies on hypotensive anesthesia have shown a statistically significant reduction in blood loss .
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Between 21 and 40 years of age, they with American Society of Anesthesiologists (ASA) physical status I-II and undergoing nasal and paranasal sinus surgery.
排除标准
- •• Refusal to join the study.
- •Allergy to the drugs used in the study.
- •Drug and/or alcohol abuse.
- •Mental and psychiatric disorders.
- •Emergency operations.
- •Patients with systemic illnesses (eg, hypertension [ SBP >160 mm Hg], diabetes mellitus.
研究组 & 干预措施
Dexmedtomidine group
About 40 patients will receive bolus dose of dexmedetomidine 0.5-1 μg/kg in 100 mL of normal saline over 10 minutes then, continuous infusion dose of dexmedetomidine 0.2 ug/kg/hr.
干预措施: Dexmedetomidine (Drug)
ketamin group
About 40 patients will receive a ketamine bolus dose (0.3 mg/kg IV slowly), then continuous infusion dose of ketamine (0.2 mg/kg/hr).
干预措施: Ketamine Hydrochloride (Drug)
结局指标
主要结局
The postoperative pain
时间窗: from 0 hours to 24 hours after the procedure
Assessed by VAS score.As (VAS:0-10, where 0 = no pain, and 10 = worst possible pain). Before surgery, all patients will be a short education about VAS.
次要结局
未报告次要终点
研究者
Ahmed Hegazy
Resident of Anesthesia, intensive care and pain management Faculty of Medicine - Al-Azhar University
Al-Azhar University