Intramuscular Ketamine Effect on Postnasal Surgery Agitation: a Double Blinded Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Development of Agitation
研究概览
简要总结
Emergence agitation (EA) is a common complication after nasal surgery. In this study, we aimed to investigate the effect of intramuscular ketamine on EA following septoplasty and open septorhinoplasty (OSRP) when administered at subanesthetic doses at the end of surgery. Sedation and Agitation scores were recorded using The Richmond agitation-sedation score after extubation.
详细描述
At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K, whereas 2 mL of normal saline was administered intramuscularly to Group-S using a 3 ml syringe. The injection site of both groups was at the lateral thigh. For postoperative analgesia, 0.07 mg/kg morphine was also given when turning off the inhalational agent. A nasal pack was used in all of the patients. The patients were ventilated with 100% oxygen at a flow rate of 7 L/min. Once the patients met the extubation criteria, they were extubated.
The EA level of the patients was evaluated immediately after extubation till the patient was handed over to the PACU using Richmond Agitation-Sedation Scale (RASS), Table 1, and the highest score was documented by the main investigators. In this study patients with a RASS score of +2 or more were considered to have EA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age group 18-64 years old
- •BMI 20-29.9
- •Patients accepting the study and consenting
- •Undergoing general anesthesia for scheduled septoplasty or open septorhinoplasty.
排除标准
- •ketamine allergy
- •Morphine allergy
- •History of cardiac, neurological, or psychiatric disease, glaucoma,
- •Patients with a body mass index of less than 20 or more than 30 kg/m2
研究组 & 干预措施
group-K
At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K
干预措施: Ketamine Hydrochloride (Drug)
结局指标
主要结局
Development of Agitation
时间窗: immediately After extubation.
Using The Richmond agitation-sedation score. The score being from(-5) to (+4) ; 2 and more being agitated patients and less than 2 not agitated.
次要结局
未报告次要终点
研究者
Husam A. Almajali
anesthesia specialist
Jordanian Royal Medical Services