Efficacy of External Nasal Nerve Block on Postoperative Agitation Following Nasal Surgeries Under General Anesthesia. Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Quality of recovery
研究概览
简要总结
Emergence agitation following general anaesthesia may lead to serious complications like self-extubation or removal of catheters, which can lead to hypoxia, aspiration pneumonia, bleeding or reoperation. Nose surgery is associated with a higher incidence of emergence agitation. The investigators planned to evaluate the efficacy of external nasal nerve block in prevention of postoperative agitation following external nasal surgeries under general anesthesia(GA).
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •110 adult patients of ASA physical status I and II,
- •Age 20-60 years,
- •Scheduled for elective external nasal surgeries in which nasal packing on each side was used postoperatively for 24 hours.
排除标准
- •History of uncontrolled hypertension,
- •Ischemic or valvular heart disease,
- •Use of MAO inhibitors or adrenergic blocking drugs,
- •Cognitive impairment,
- •Patients taking antipsychotics,
- •Renal insufficiency or liver dysfunction
研究组 & 干预措施
Group I(control)
patients allocated for external nasal nerve block with saline adrenaline 1/200,000 (placebo)
干预措施: External nasal nerve block (Procedure)
Group I(control)
patients allocated for external nasal nerve block with saline adrenaline 1/200,000 (placebo)
干预措施: saline adrenaline (Drug)
Group II(block)
'External nasal nerve block by Xylocaine, adrenaline'
干预措施: External nasal nerve block (Procedure)
Group II(block)
'External nasal nerve block by Xylocaine, adrenaline'
干预措施: Xylocaine, adrenaline (Drug)
结局指标
主要结局
Quality of recovery
时间窗: 24 hours postoperative
Quality of recovery
postoperative agitation
时间窗: Emergence is defined as the time interval from discontinuation of anesthesia to 5 min after extubation.
Assessment done using Richmond agitation- sedation scale (RASS)
次要结局
- Extubation time(Up to 15 after discontinuation of anesthesia)
- Surgical time(duration of surgery in minutes up to 3 hours)
- first verbal response time(up to 15 minutes)
- dose of fentanyl(intraoperative period in minutes)
- complication of nasal block(From injection to 24 hours postoperative)
- morphine dose in PACU(one hour in PACU)
- Nausea and vomiting in PACU(one hour in PACU)
研究者
Dr. Mohamed Ibrahim
Assistant Professor of Anesthesiology- Zagazig University - Consultant of anesthesia
Al Jedaani Hospital