Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The incidence of emergence agitation.
研究概览
简要总结
- emergence agitation is seen in around 68% after nasal surgeries. Agitated patients needs more staff and nurses to control their abnormal movement which leads to self extubation , removal of catheters and bruises in the extremities.
- Dexmedetomidine, ketamine, propofol intravenous infusion and other agents was used to prevent EA . Recently, ketodex is found to reduce the incidence and severity of EA .
- We aim to compare single bolus dose of Ketodex Versus Ketofol For Prevention Of emergence Agitation in adults undergoing nasal surgeries.
详细描述
The incidence of emergence agitation (EA) after nasal surgeries is relatively high , it is reported to be 68% (1).The precise mechanism is not known. Awake extubation after nasal surgeries is preferred as the airway may be contaminated by blood , and the nasal airway may be blocked by surgical packs that causes sense of suffocation. Awake extubation and nasal pack is a trigger to emergence agitation(2).
emergence agitation (EA) is harmful to the patient and the staff, it Characterized by disorientation, confusion, abnormal violent movement that may result in serious complication and morbidity(3). It develops early with the recovery from general anesthesia(4). Although agitation is more observed in pediatrics but its incidence in adults reach up to 21.4% (5).
Different medication agents such as anesthetic drugs, benzodiazepine and α2 agonist was proved to attenuate the EA with different efficiencies (6).
Dexmedetomidine is a selective α2 adrenoceptor agonist. It has sedative, hypnotic, anxiolytic, analgesic and sympatholytic properties. It was proved to reduce the EA in children(7). However there was few data about its effect in reducing the agitation in adult after general anesthesia(8).
Propofol is short acting hypnotic and sedative agent. It is used for induction and maintenance of anesthesia(9). Previous studies proved that propofol was effective in preventing EA (10,11) and depends on the time of administration(12).
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
- Double (Participant, Outcomes Assessor)
盲法说明
patient and outcomes assessor
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient acceptance.
- •Both gender.
- •Age (21-60) years old.
- •patient with Body Mass Index (BMI) (25-35kg/m²).
- •American Society of Anesthesiologist (ASA) I / II
- •Adult patient scheduled to elective nasal surgeries
排除标准
- •- Patient with difficult airway (mallampati III,IV).
- •Altered mental status (psychiatric and anxiety disorder).
- •Post traumatic stress disorders.
- •History of allergy to study drugs.
- •Patient on sedative or hypnotic medication.
- •Patients with chronic pain or on painkiller.
- •Patients with severe hepatic or kidney impairment.
- •Patients having a history of thyrotoxicosis, hypertension, cardiac , chest or neurological disease.
- •Patient receiving B agonist.
- •Pregnant or breast feeding female.
研究组 & 干预措施
ketodex
ketamine dexmedetomidine mixture
干预措施: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline" (Drug)
ketofol
ketamine propofol mixture
干预措施: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline" (Drug)
placebo
normal saline
干预措施: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline" (Drug)
结局指标
主要结局
The incidence of emergence agitation.
时间窗: up to 60 minutes after extubation
The incidence of emergence agitation.
The level of emergence agitation.
时间窗: up to 60 minutes after extubation
The level of emergence agitation measured by . Richmond Agitation-Sedation scale (RASS) is ten scales; five for sedation level ,one for alertness and calmness, and four for agitation level as follow: -5 unarousable , -4 deep sedation , -3 moderate sedation , -2 light sedation , -1 drowsy ; 0 alert and calm,+1 restless , +2 agitated , +3 very agitated and +4 combative. Patients with score ≥ 2 considered having agitation.
次要结局
- The Emergence time(up to 20 minutes after discontinuation of isoflurane)
- The extubation time(up to 20 minutes after discontinuation of isoflurane)
- The time of discharge(up to 40 minutes after extubation)
- Postoperative Pain is evaluated using Numerical rating Scale (NRS)(up to 40 minutes after extubation)
- "Number of Participants with vomiting or hypotension or bradycardia"(all over 40 minutes post-operative)
研究者
olfat abd elmoniem ibrahem
principle investigator
Zagazig University