Comparative Low and High Dose of Dexmedethomidine Can Stabilize Hemodynamics and Blood Loss in Pituitary Tumor Removal by Transphenoid Approach
试验速览
- 阶段
- 4 期
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach
研究概览
简要总结
Transnasal transsphenoidal (TNTS) resection of pituitary tumors involves wide fluctuation in hemodynamic parameter and causes hypertension and tachycardia due to intense noxious stimuli during various stages of surgery. None of routinely used anesthetic agents effectively blunts the undesirable hemodynamic responses, and therefore usually there is a need to use increased doses of anesthetic agents. Dexmedetomidine (DEX) an α-2 adrenergic receptor agonist, because its sympatholytic and antinociceptive properties may ensure optimal intraoperative hemodynamic stability during critical moments of surgical manipulation. In addition, DEX reduced the anesthetic requirement with rapid recovery at the end of surgery. The main aim of the study was to evaluate the effect of DEX on perioperative hemodynamics, anesthetic requirements
详细描述
DEX as an anesthetic adjuvant improved hemodynamic stability and decreased anesthetic requirements in patients undergoing TNTS resection of pituitary tumor. In addition, DEX provided better surgical field exposure conditions and early recovery from anesthesia
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
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective TNTS resection of Pituitary Tumor
- •No narcotic before surgery as premedication
- •Able to Extubate
排除标准
- •GCS less than 15
- •Preoperative Heart Rate less than 50 beat/min
- •No Beta-Blockers
- •Pregnant patients
- •Take any Alpha-Methyldopa, Clonodine, Other Alpha-2 Adrenergic Agonist
- •Hemodynamic unstable
- •Systolic BP more than 160mmHg
- •Renal insuffuciency
- •Allergy in dexmedethomidine and opioid
- •BMI more than 30
- •Denied consent
研究组 & 干预措施
High dose dexmedethomidine
High dose is 0.5 microgram/kg/hr
干预措施: high dose dexmedethomidine (Drug)
Low dose dexmedethomidine
Low dose is 0.2 microgram/kg/hr
干预措施: low dose dexmedethomidine (Drug)
结局指标
主要结局
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach
时间窗: 24 hours
Low dose is 0.2microgram/kg/hr High dose is 0.5 microgram/kg/hr what is the dose proper and hemodynamic changes. Hemodynamic change means BP is lower than 20% of baseline more than 10minute
次要结局
- Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor(24 hours)
研究者
SMuangman
Assisted Professor
Mahidol University