Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Response to verbal stimulus time
研究概览
简要总结
This randomized double-blind study aimed to compare the effects of dexmedetomidine and ketamine on hemodynamic parameters, recovery criteria, and opioid consumption and advers effects in septorhinoplasty operations. Totally 63 patients were included.
The groups were compared in terms of hemodynamic values, recovery times, postoperative agitation, sedation, activity, modified Aldrete and pain scores, side-effects and additional analgesia requirements at postoperative 24h.
详细描述
A total of 63 patients 18-55 years undergoing septorhinoplasty, who were graded as American Society of Anesthesiologists physical status were randomly allocated into three groups, receiving dexmedetomidine (n=21, Group D), ketamine (n=21, Group K) and saline solution (n=21, Group S). Anesthesia was induced with propofol, cisatracurium and fentanyl. Maintenance anesthesia was done with 2-2.5% sevoflurane mixture, 50-60% oxygen and N2O. The groups were compared in terms of hemodynamic values, recovery times, postoperative agitation, sedation, activity, modified Aldrete and pain scores, side-effects and additional analgesia requirements at postoperative 24h.
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)
盲法说明
The surgeon and observers were all blinded to the patients until the end of the study.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient graded as American Society of Anesthesiologist (ASA) physical status, I or II
- •Patient subjected to septorhineoplasty operation
排除标准
- •Patient having morbid obesity,
- •Patient having yypertension,
- •Patient having Asthma,
- •Patient having neuropsychiatric disease,
- •Patient allergy to the study drugs.
研究组 & 干预措施
Dexmedetomine
Patients recieving Dexmedetomidine.
干预措施: Dexmedetomidine (Drug)
Ketamine
Patients recieving Ketamine.
干预措施: Ketamine (Drug)
Placebo
Patients recieving Saline.
干预措施: Saline (Drug)
结局指标
主要结局
Response to verbal stimulus time
时间窗: 0-120 minutes following finishing operation
Verbal response received when the patient was spoken to
Intraoperative additional fentanyl requirement
时间窗: 0-120 minutes following initiating operation
Intraoperative additional fentanyl requirement for pain relief and
次要结局
- Heart rate(0-120 minutes)
研究者
Muge Kosucu
Clinical Associated Professor
Karadeniz Technical University