Effect of Dexmedetomidine on Intraoperative Neuroendocrine Stress Response and Early Postoperative Quality of Recovery in Non-functioning Pituitary Adenoma Patients Undergoing Endoscopic Transsphenoidal Tumor Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Quality of recovery-15 (QoR-15) score
研究概览
简要总结
In multiple previous studies that have explored the use of dexmedetomidine in transsphenoidal tumor resection surgery, dexmedetomidine showed many beneficial effects like reducing the requirement of analgesics and anesthetics, improving hemodynamic stability and decreasing the emergence time, extubation time and visual analog scale at emergence. Therefore, the investigators hypothesized that dexmedetomidine would decrease neuroendocrine stress response and improve the quality of postoperative recovery.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-functioning patients undergoing endoscopic transsphenoidal tumor surgery under general anesthesia
排除标准
- •Patients who do not agree to participate in the study
- •Patients with contraindication to dexmedetomidine
- •Patients with previous history of endoscopic transsphenoidal tumor surgery
- •Patients who take anticoagulants or have bleeding disorder
- •Patients with conduction block or cardiovascular disease
- •Patients with psychiatric disease such as dementia, delirium
- •Patients have difficulty filling out the QoR-15 questionnaire
- •Pregnant or lactating women
- •Patients who have allergies to propofol, remifentanil, fentanyl or rocuronium
- •Patients with myasthenia gravis or myasthenic syndrome
研究组 & 干预措施
Control group
After the induction of anesthesia, the control group received intravenous normal saline at the same loading volume for 10 min, followed by the same volume until the end of surgery.
干预措施: normal saline (Drug)
Dexmedetomidine group
After the induction of anesthesia, the dexmedetomidine group received intravenous dexmedetomidine at a loading dose of 1µg/kg for 10 min, followed by a maintenance dose of 0.5µg/kg/h until the end of surgery.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Quality of recovery-15 (QoR-15) score
时间窗: postoperative day 1
Self-rated questionnaire composed of 15 items (each item: 0-10 points, total: 0-150 points) of five dimensions: physical well-being, physical independence, emotional state, psychological support, and pain. Higher scores indicate better quality of recovery.
次要结局
- Serum level of triiodothyronine (T3)(preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery))
- Serum level of cortisol(preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery))
- Pain score (visual analogue scale, VAS)(postoperative 4 hour, 1 day, 2 day)
- Serum level of triiodothyronine (T4)(preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery))
- Serum level of thyroid stimulating hormone (TSH)(preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery))
- Incidence and severity of postoperative complications(postoperative (up to 2 weeks after surgery))
- Serum level of luteinizing hormone (LH)(preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery))
- Serum level of follicle stimulating hormone (FSH)(preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery))
- Serum level of adredocorticotrophic hormone (ACTH)(preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery))
- Time to the first administration of rescue analgesics after the end of surgery(postoperative (up to 2 weeks after surgery))
- Total amounts of propofol and remifentanil administered during surgery(intraoperative (from induction of anesthesia until end of anesthesia))
- Serum level of prolactin(preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery))
- Time to emergence after the end of surgery(postoperative (up to 1 day after surgery))
- Hospital length of stay(postoperative (up to 2 weeks after surgery))
- Serum level of growth hormone (GH)(preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery))
- Serum level of insulin-like growth factor-1 (IGF-1)(preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery))
- Serum level of antidiuretic hormone (ADH)(preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery))
- Total amounts of rescue analgesics(postoperative (up to 2 weeks after surgery))
- Time to extubation after the end of surgery(postoperative (up to 1 day after surgery))
研究者
Hee-Pyoung Park
Professor
Seoul National University Hospital