Efficacy of Remifentanil in Preventing Emergence Agitation in Patients Undergoing Nasal Surgery Under Desflurane Anesthesia: A Prospective Double-blind Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Richmond Agitation-Sedation Scale (RASS)
研究概览
简要总结
The primary aim of the study was to test the hypothesis that remifentanil administered for analgesia prevents emergence agitation more effectively than fentanyl and N2O in patients undergoing rhinoplasty who received desflurane as an inhaled anesthetic agent. The secondary aim of the study was to compare the demographic data, intraoperative and postoperative hemodynamic data, surgical time and modified Aldrete score of patients who received different intraoperative analgesia methods.
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
- Triple (Participant, Care Provider, Investigator)
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
- 是
入选标准
- •The study included patients over the age of 18, planned to undergo rhinoplasty by the plastic and reconstructive surgery department, and American Society of Anesthesiologist (ASA) I-II.
排除标准
- •Patients with a known history of allergy to the drugs to be administered in the study, ASA III and above, body mass index (BMI) 35>kg/m2, younger than 18 years of age, any problems that would prevent general anesthesia in the preoperative evaluation (upper respiratory tract infection, etc.), and those who did not agree to participate in the study were excluded from the study.
研究组 & 干预措施
group 1 Remifentanily
Patients in Group 1 received 0.05-0.2 μg/kg/min IV remifentanil infusion as analgesic.
干预措施: Remifentanil (Drug)
group 2 N2O
N2O instead of 50% air was applied to patients in Group 2 for intraoperative analgesia.
干预措施: N2O (Drug)
group 3 Fentanly
In addition to Desflurane, 50% oxygen and 50% air, 1 μg/kg IV fentanyl bolus was administered as analgesic when there was a 20% increase in heart rate and blood pressure values during the operation for patients in Group 3.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Richmond Agitation-Sedation Scale (RASS)
时间窗: Postoperative care unit 1.second_5. second_15.second
* 4 Combative, violent, danger to staff * 3 Pulls or removes tube(s) or catheters; aggressive * 2 Frequent non-purposeful movement, fights ventilator * 1 Anxious, apprehensive, but not aggressive 0 Alert and calm * 1 Awakens to voice (eye opening/contact) \> 10 seconds * 2 Light sedation; briefly awakens to voice (eye opening/contant) \< 10 seconds * 3 Moderate sedation; movement or eye opening. No eye contact * 4 Deep sedation; no response to voice, but movement or eye opening to physical stimulation * 5 Unarousable; no response to voice or physical stimulation
次要结局
- mean arterial pressure(Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min)
- Heart rate(Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min)
研究者
Hülya Tosun Söner
Anesthesiology and Reanimation Spesialist
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital