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临床试验/NCT04356196
NCT04356196Unknown早期 1 期

Comparative Study Between the Efficacy of Verapamil and Bisoprolol on Reduction of Bleeding During Endoscopic Sinus Surgery Under General Anaesthesia.

Assiut University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2021年6月15日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

45 patients will receive 80 mg oral verapamil 3 hours pre-operative

干预措施: Verapamil (Drug)

Bisoprolol group

Experimental

45 patients will receive Bisoprolol 5mg PO 3 hours preoperative

干预措施: Bisoprolol (Drug)

placebo group

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Ali Hassan Refaat AL-Quossi

Assistant lecturer

Assiut University

研究点 (1)

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