“Effect of preoperative dexmedetomidine nebulisation as an adjunct to adrenaline nasal packing on surgical field quality and haemodynamic stability during transsphenoidal resection of pituitary adenoma: A prospective randomised double-blinded clinical study”
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess the efficacy of nebulised dexmedetomidine on surgical field quality in patients undergoing transsphenoidal resection of pituitary adenoma using Formmer’s surgical field score (scored by a single operating neurosurgeon at defined time points).
研究概览
简要总结
Randomised trials for the efficacy of inhalational dexmedetomidine on intraoperative haemodynamic and surgical field quality in patients undergoing transsphenoidal resection of pituitary adenoma are currently very limited. Hence this study has been designed.
Dexmedetomidine has been widely studied in many surgical settings with possible benefits in lowering anaesthetic requirements, improving perioperative haemodynamic stability, and improving postoperative outcomes. This study aims to shed light on its potential as an adjuvant agent in anaesthesia for the specific surgical population and the efficacy of the inhalational route of administration of dexmedetomidine.
Nebulized dexmedetomidine is a well-tolerated alternative to intravenous administration, with promising results in attenuating the haemodynamic stress response during airway manipulation and improving patient comfort. However, there is a paucity of data regarding its impact on surgical field conditions and intraoperative haemodynamics in the context of neurosurgical procedures, especially endonasal transsphenoidal pituitary surgeries where minimal bleeding and stable conditions are critical.
This study is designed to evaluate whether the addition of nebulised dexmedetomidine to standard adrenaline nasal packing enhances surgical field visibility and provide better haemodynamic control, thus offering a potential safer and more effective anaesthetic strategy for this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Age: 18 to 65 years BMI up to 30 kg/m2 ASA Physical Status I, II.
- •Scheduled for elective transsphenoidal pituitary surgery.
排除标准
- •GCS less than 12 and elevated ICP History of known dexmedetomidine allergy Patients with significant cardiovascular and respiratory disease Patients coming for emergency surgery, pregnant patients.
- •Individuals with Cushing syndrome and Acromegaly.
结局指标
主要结局
To assess the efficacy of nebulised dexmedetomidine on surgical field quality in patients undergoing transsphenoidal resection of pituitary adenoma using Formmer’s surgical field score (scored by a single operating neurosurgeon at defined time points).
时间窗: To assess the efficacy of nebulised dexmedetomidine on surgical field quality in patients undergoing transsphenoidal resection of pituitary adenoma using Formmer’s surgical field score (scored by a single operating neurosurgeon at defined time points).At the end of the surgery
次要结局
- To evaluate the efficacy of nebulised dexmedetomidine on haemodynamic response in patients undergoing transsphenoidal resection of pituitary adenoma
研究者
Dr Muhammed Thoufeeq T
AIIMS RAIPUR
