Bilateral Supra-Zygomatic Sphenopalatine Ganglion Block Versus Dexmedetomidine for Relief of Postoperative Pain and Surgical Field Improvement in Trans-nasal Endoscopic Pituitary Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Postoperative pain using VAS scale.
研究概览
简要总结
Improving pain and surgical field by using sphenopalatine ganglion block and dexmedetomidine in trans-nasal endoscopic pituitary surgery.
详细描述
Pituitary neoplasm is one of the most common sellar pathology. Trans-nasal endoscopic pituitary surgery (TEPS) evolved rapidly, almost replacing the craniotomy approach. TEPS, a surgical instrument, is primarily executed through a minimally invasive approach through the nostril to access a pituitary tumor.
That is why the anesthetic plan must ensure the best possible surgical field visualization and the most adequate analgesia.
Multimodal anesthesia including regional and general anesthesia are obtained to optimize surgical field by decreasing bleeding, reduce pain, promote rapid recovery and potential economic gains for the hospital.
The sphenopalatine ganglion block (SPGB) is considered one of the regional anesthetic techniques that is safe and easy anesthetic procedure used to control bleeding and for postoperative analgesia.
Dexmedetomidine (DEX) has become popular for induced hypotension. It is an α2-adrenoceptor agonist with a sympatholytic and analgesic effect. It provides a unique conscious sedation without respiratory depression. It is used effectively in optimizing surgical field through its hemodynamic stability effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: between 21-64 years old.
- •sex: males and females.
- •Body mass index: 35 kg/m
- •ASA Physical status: grade Ⅰ-Ⅱ.
排除标准
- •patients receiving beta blockers, anti-coagulants and antihypertensive medications also patients receiving clonidine or benzodiazepines, neuroleptics or antidepressants two weeks prior to the study.
- •Any contraindication for regional anesthesia e.g. coagulopathy, infection at site of block and hypersensitivity to any drug used in this study.
- •Patients who are known to be drug addict.
研究组 & 干预措施
Group C (control group) (n=23) patients will be operated under general anesthesia.
干预措施: General Anesthesia (control group) (Other)
Group SPGP (n=23) patients will receive ultrasound guided bilateral sphenopalatine block
干预措施: Sphenopalatine Ganglion Block (Procedure)
Group DEX (n=23) patients will receive dexmedetomidine drug.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Postoperative pain using VAS scale.
时间窗: 24hours
Pain will be assessed based on VAS scale from (1-10), as 1 is the least pain and 10 is the maximal pain possible at 2, 4, 6, 12 and 24h after surgery.
Surgical field using Average Category Scale (ACS).
时间窗: 5hours
Done by asking the surgeon about amount of bleeding on a scale of (0-5) as 0= no bleeding and 5= sever bleeding, every 15 min interval till the end of surgery.
次要结局
未报告次要终点