The Effect of Intramuscular Dexmedetomidine Versus Oral Gabapentin Premedication on the Emergence Agitation After Rhinoplasty. A Prospective, Randomized, Double-blind Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- emergence agitation (EA)
研究概览
简要总结
To compare the effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty.
详细描述
Emergence agitation (EA) is a clinical condition characterized by agitation, confusion, disorientation, and aggressive behavior in the early phase of recovery from general anesthesia (incidence about 21.3%). This may lead to various injuries, self-extubation, bleeding, increased pain, removal of catheters, increased blood pressure, heart rate, and myocardial oxygen consumption. Premedication with dexmedetomidine and gabapentin are promising options for 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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists grade I or II.
- •Sex: Both sexes.
- •Age between 18 and 40 years.
- •Patients scheduled for rhinoplasty under general anesthesia
排除标准
- •Declining to give written informed consent.
- •History of allergy to the medications used in the study.
- •history of cardiovascular diseases including bradycardia, heart block, and hypertension.
- •History of chest problems including bronchial asthma.
- •Had a history of drug or alcohol abuse.
- •Taking opioids or sedative medications.
- •Inability to communicate with patients to evaluate postoperative pain.
- •Hepatic or renal failure.
- •Psychiatric disorders with antipsychotics or antidepressants.
- •Bleeding disorders, antiplatelets (aspirin, clopidogrel), or anticoagulant (warfarin).
研究组 & 干预措施
Dexmedetomidine
The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward
干预措施: Dexmedetomidine (Drug)
Gabapentin
The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward
干预措施: Gabapentin (Drug)
结局指标
主要结局
emergence agitation (EA)
时间窗: During first hour of recovery.
in the form of Riker Sedation-Agitation Scale (where 1 = "unarousable" and 7 = "dangerous agitation" with score ≥5 considered EA).
次要结局
- Postoperative pain in the form of visual analog scale(every 4 hours for 12 hours)
- Incidence of the common adverse effects(at 12 hours)
研究者
Tamer Samir Abdelsalam
lecturer of Anesthesia
Ain Shams University