NCT05822817已完成4 期
A Prospective, Randomized Controlled Study to Compare the Effect of Sevoflurane and Propofol for Maintenance of Anesthesia on Postoperative Recovery After Transsphenoidal Resection of Pituitary Adenoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- 15-item quality of recovery score (QoR-15)
研究概览
简要总结
Currently, total intravenous anesthesia (TIVA) and inhaled anesthesia are both commonly used for transsphenoidal pituitary adenoma resection. However, optimal choice for anesthesia maintenance in transsphenoidal surgery remains unclear. Previous studies focusing on this question provided fragmentary assessment and controversial results. The goal of this clinical trial is to investigate whether propofol and sevoflurane have different effect on post-anesthetic recovery after transsphenoidal resection of pituitary adenoma.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, aged from 18 to 70
- •American Society of Anesthesiologists (ASA) class I - III
- •Patients scheduled for transsphenoidal surgery requiring general anesthesia managed with endotracheal intubation
排除标准
- •Patients allergic or contraindicated to sevoflurane, propofol, or other drugs used during surgery
- •Severe pulmonary disease, saturation of peripheral oxygen (SpO2) < 90%
- •Severe nervous system disease with consciousness disorder
- •Patients scheduled for intensive care unit (ICU) after surgery
研究组 & 干预措施
sevoflurane
Experimental
Anesthesia is maintained with sevoflurane.
干预措施: sevoflurane (Drug)
propofol
Experimental
Anesthesia is maintained with continuous infusion of propofol.
干预措施: propofol (Drug)
结局指标
主要结局
15-item quality of recovery score (QoR-15)
时间窗: 24 hours after end of surgery
The QoR-15 score ranges from 0 to 150 (higher is better). The investigators record the scores of two groups 1 day after the surgery.
次要结局
- Time to awake from anesthesia(From stopping sevoflurane or propofol to awake, approximately 30 minutes)
- Time to extubation(From stopping sevoflurane or propofol to recovery of spontaneous breathing and withdrawal of tracheal tube, approximately 30 minutes)
- Coughing and bucking during emergence(From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes)
- Time to discharge from postanesthesia care unit (PACU)(From admit into PACU to discharge from PACU, approximately 45 minutes)
- Concentration of serum growth hormone (GH)(24 hours after end of surgery)
- Incidence of hypotension during anesthesia(From start of surgery to end of surgery, on an average of 2 hours)
- Concentration of serum thyroid-stimulating hormone (TSH)(24 hours after end of surgery)
- Concentration of serum prolactin (PRL)(24 hours after end of surgery)
- Counts of peripheral blood lymphocyte(24 hours after end of surgery)
- Agitation or sedation level during emergence(From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes)
- PACU antiemetic drug use(From admit into PACU to discharge from PACU, approximately 45 minutes)
- PACU analgesic drug use(From admit into PACU to discharge from PACU, approximately 45 minutes)
- Post operative nausea and vomiting score(24 hours after end of surgery)
- Concentration of serum adrenocorticotropic hormone (ACTH)(24 hours after end of surgery)
- Concentration of serum cortisol(24 hours after end of surgery)
- Concentration of serum gonadotrophin(24 hours after end of surgery)
- Incidence of hypertension during anesthesia(From start of surgery to end of surgery, on an average of 2 hours)
- Time to discharge from hospital(From end of surgery to discharge from hospital, on an average of 2 days)
研究者
研究点 (1)
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