Comparative Study Between the Efficacy of Verapamil and Bisoprolol on Reduction of Bleeding During Endoscopic Sinus Surgery Under General Anaesthesia.
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Estimated Blood Loss
研究概览
简要总结
The study aims to compare the effect of addition of verapamil and Bisoprolol to general anasthesia aimed reduction in heart rate and blood loss during endoscopic sinus surgery.
详细描述
Intra-operative bleeding presents a larger obstacle to endoscopic visualization. Blood obscures the anatomy of the surgical field and dirties the endoscope lens causing greater difficulty with visualization. This situation increases the risk of complications, including brain injury, orbital or optic nerve injury, and catastrophic bleeding from major vessels (e.g., internal carotid artery) 1.
Endoscopic sinus surgery (ESS) 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. The term ESS is used to draw attention to the potential for reestablishing natural mucociliary clearance mechanism, drainage and aeration of sinuses, whilst maintaining as much of the normal anatomy as possible. Over last few years this technique has become popular worldwide due to its minimally invasive nature and preservation of mucosa2.
Continued bleeding into the surgical field during ESS not only impairs endoscopic vision but can lead to complications3. Compared with conventional anesthesia, total intravenous anesthesia (TIVA) has been previously reported to result in reduced blood loss when used for FESS. However, few recent studies point out that TIVA may not significantly reduce blood loss 4-5.
Controlled hypotension has been used to reduce bleeding and the need for blood transfusions, and provide a satisfactory bloodless surgical field . Controlled hypotension is defined as a reduction of the systolic blood pressure to 80-90 mm Hg, a reduction of mean arterial pressure (MAP) to 50-65 mm Hg or a 30% reduction of baseline MAP 6. 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 7 .
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
- 是
入选标准
- •Age of 18 - 60 years.
- •patients of both genders.
- •ASA grade I - II.
排除标准
- •Patient refusal.
- •Any contraindication of B- blocker:
- •Athma , COPD
- •Bradycardia , Heart block
- •Acute decompensated heart failure
- •Peripheral vascular disease
- •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.
研究组 & 干预措施
Verapamil group
45 patients will receive 80 mg oral verapamil 3 hours pre-operative
干预措施: Verapamil (Drug)
Bisoprolol group
45 patients will receive Bisoprolol 5mg PO 3 hours preoperative
干预措施: Bisoprolol (Drug)
placebo group
45 patients will receive placebo tablet PO 3 hours preoperative .
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.
Heart Rate
时间窗: intraoperative
heart beats for minutes
次要结局
- plasma norepinephrine concentrations(baseline before Anastasia ( in the holding area with insertion of I.V. cannula) and three hours after the end of surgery.)
- serum cortisol concentrations(baseline before Anastasia ( in the holding area with insertion of I.V. cannula) and three hours after the end of surgery.)
- The Boezaart and van der Merwe intraoperative surgical field scale(Every 15 minutes for the duration of surgery)
研究者
Mohammed Ali Hassan Refaat AL-Quossi
Assistant lecturer
Assiut University
