Efficacy of Oral Diltiazem Versus Combination of Oral Diltiazem With Intravenous Tranexamic Acid on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 40
- 主要终点
- Estimated Blood Loss
研究概览
简要总结
- The primary endpoint is the effect of the addition of oral Diltiazem and Tranexamic Acid to general anesthesia aided reduction in blood loss during functional endoscopic sinus surgery (FESS).
- The secondary endpoint is surgeon's assessment of the surgical field and hemodynamics.
详细描述
Functional endoscopic sinus surgery (FESS) is a minimally invasive technique used to restore sinus ventilation and function in patients with recurrent acute or chronic infective sinusitis in whom medical therapy has failed.
Continued bleeding into the surgical field during FESS not only impairs endoscopic vision but can lead to complications.
Controlled hypotension is a technique used to limit intraoperative blood loss to provide the best possible field for surgery. The physiological principle which underlies hypotensive anesthesia is a natural survival mechanism. When profuse bleeding occurs, the blood pressure drops. This drop leads to a reduction or cessation of the bleeding, blood pressure stabilization, and recovery. Accordingly, reducing the patient's blood pressure during surgery can potentially reduce overall bleeding. Since bleeding in the surgical field is also reduced, the surgical field operating conditions are improved In hypotensive anesthesia, the patient's baseline mean arterial pressure (MAP) is reduced by 30 %. Consequently, the systolic blood pressure values are about 80-90mmHg and the MAP is reduced to 50- 65mmHg.
Hypotensive anesthesia is considered to be a suitable anesthetic technique for those patients who will be undergoing spinal surgery, hip or knee arthroplasty, craniosynostosis, hepatic resections, and major maxillofacial operations. Benefits for controlled hypotension for FESS include the reduction in blood loss with improved quality of the surgical field.
Various agent's anesthetic agents, analgesics, and hypotensive drugs, that have been used for achieving hypotensive anesthesia:
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •include patients who undergoing elective FESS under general anesthesia and meet these criteria:
- •Age from 18 - 60 years old. - ASA grade I - II.
排除标准
- •- Patient refusal.
- •Any contraindication of calcium channel blocker:
- •AV conduction defects (2nd and 3rd degree AV block).
- •Sick sinus syndrome.
- •Wolf-Parkinson-White Syndrome.
- •History of congestive heart failure.
- •Patients on long-term ß-blocker therapy.
- •Patients with allergy to medication included in the study.
- •Any contraindication of Tranexamic Acid:
- •bleeding disorders.
- •pregnant or breastfeeding mothers.
- •patient under the influence of anticoagulants.
研究组 & 干预措施
1st group
20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative
干预措施: oral Diltiazem (Drug)
2nd group
20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative+ 10 mg/kg IV Tranexamic Acid slow infusion with saline half an hour before the induction of anesthesia
干预措施: oral Diltiazem (Drug)
2nd group
20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative+ 10 mg/kg IV Tranexamic Acid slow infusion with saline half an hour before the induction of anesthesia
干预措施: IV Tranexamic Acid (Drug)
3rd group
20 patients will receive oral placebo tablet 3 hours pre-operative
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Estimated Blood Loss
时间窗: end of operation assessment
Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery dividing by surgical time in hours.
次要结局
- Incidence of hypotension(Hemodynamic parameters as systolic, diastolic and mean arterial blood pressures were recorded before drug intake, before induction, after induction, intraoperative every 5 minutes till the end of surgery, every 15 minutes post operative)
- End Tidal CO2(End Tidal CO2 before induction, after induction, intraoperative every 5 minutes till the end of surgery)
- total consumption of propofol(end of operation assessment)
- The Boezaart and van der Merwe intraoperative surgical field scale(Every 15 minutes for the duration of surgery)
- Heart Rate(Heart Rate recorded before drug intake, before induction, after induction, intraoperative every 5 minutes till the end of surgery, every 15 minutes postoperative)
研究者
Moutaz Ragab Ismail Ibrahim
M.D
Assiut University