NCT05301634已完成3 期
Comparison Between Hemodynamic Effect of Bilateral Infraorbital Block Versus Intranasal Application of Bupivacaine in Patients Undergoing Transsphenoidal Pituitary Adenoma Resection.A Comparative Randomized Controlled Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean arterial blood pressure
研究概览
简要总结
The study will evaluate the efficacy of bilateral infraorbital nerve block versus preoperative nasal packing with long-acting local anesthetic bupivacaine in term of maintaining hemodynamics intraoperative within 20% below baseline to achieve adequate hypotensive anesthesia and longer duration of postoperative analgesia up to 24 hours in patients undergoing transsphenoidal pituitary adenoma resection.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I, II or III
- •patients scheduled to undergo endoscopic transsphenoidal approach to remove tumor under general anesthesia
排除标准
- •Patient's refusal
- •Allergy to local anesthetics.
- •Preoperative cerebrospinal fluid leak.
- •Preoperative cardiac arrythmias.
- •Seizure disorders.
- •Patients with severe endocrinal disorders that affecting the craniofacial morphology as acromegaly and cushinoid features.
研究组 & 干预措施
Group A
Active Comparator
the patients will receive bilateral infraorbital block
干预措施: infraorbital block (Procedure)
Group B
Active Comparator
the patients will receive topical intranasal application of bupivacaine
干预措施: topical intranasal bupivacaine (Procedure)
结局指标
主要结局
Mean arterial blood pressure
时间窗: at the time of mucosal dissection
次要结局
- Intraoperative need for nitroglycerine(the entire duration of surgery)
- Postoperative need of pethidine(24 hours postoprative)
- Intraoperative need for magnesium sulphate(the entire duration of surgery)
- Intraoperative need for fentanyl(the entire duration of surgery)
- Postoperative pain assessed by Numeric pain score(24 hours postoprative)
研究者
AbdElKhalik Mahmoud Shaban
Lecturer of anaesthesia
Cairo University
研究点 (1)
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