ULTRASOUND-GUIDED PERCUTANEOUS VERSUS TRANS-NASAL PTERYGOPALATINE FOSSA BLOCK IN ENDOSCOPIC TRANS-SPHENOIDAL PITUITARY GLAND SURGERY: RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary adenoma in conjucation with general anaesthesia (GA).
研究概览
简要总结
The primary aim of this study is to compare the effect of bilateral US guided percutaneous PPFB versus transnasal approach on intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary gland surgery in conjucation with general anaesthesia (GA).Secondary aims: total dose of intraoperative dexmedetomidine, intraoperative analgesia (fentanyl), haemodynamics, the surgical field conditions, recovery pattern, and side effects
详细描述
Endoscopic endonasal transsphenoidal resection of pituitary gland is the currently most used method for the resection of pituitary tumors. It is a minimally invasive surgical technique to access sellar and parasellar lesions.
The main goal in endoscopic pituitary surgery are minimal tissue manipulation and clear bloodless field with better panoramic visualization under haemodynamic stability and good postoperative analgesia to improve the outcome .pterygopalatine fossa block (PPFB) is used to maintain haemodynamic stability and to decrease intraoperative anaesthetic requirements (PPFB)can be done transnasal or percutaneous ultrasound guided
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients belonging to American Society of Anesthesiologists (ASA) class I or II
- •patients scheduled for Endoscopic Transphenoidal Pituitary gland Surgery
排除标准
- •Patients will be excluded if; .History of allergy or contraindication to any of the studied drugs.
- •Patients for whom pterygopalatine fossa block is contraindicated (patient refusal, fascial anomalies, coagulation disorder, skin infection at the injection site) .Obese patients with BMI more than 35 Kg/m2.
研究组 & 干预措施
Bilateral trans-nasal pterygopalatine Fossa block
using 4ml 0.25% bupivacaine after the induction of GA.
干预措施: trans-nasal pterygopalatine Fossa block (Other)
Bilateral US-guided infrazygomatic percutaneous pterygopalatine Fossa block
using 4ml 0.25% bupivacaine after the induction of GA
干预措施: US-guided infrazygomatic percutaneous pterygopalatine Fossa block (Other)
结局指标
主要结局
Intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary adenoma in conjucation with general anaesthesia (GA).
时间窗: recorded after 15 minutes from the induction of anaesthesia, then every 15 minutes till the end of the surgery. Total volume of anaesthetic agent will be measured at the end of the surgery (millimeter /minutes).
The primary aim of this study is to compare the effect of bilateral US guided percutaneous PPFB versus transnasal approach on intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary gland surgery in conjucation with general anaesthesia (GA).
次要结局
未报告次要终点
研究者
Donia Hany Saad
Lecturer of anaesthesia and surgical ICU
Kafrelsheikh University