Monitored Anesthesia Care: Dexmedetomidine-Ketamine Versus Dexmedetomidine- Propofol Combination During Burr-Hole Surgery For Chronic Subdural Hematoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The onset time of sedation
研究概览
简要总结
Inadequate sedation and analgesia indicated by intraoperative movements are markers of inadequate MAC during burr-hole surgery for chronic subdural hematoma evacuation especially when general anesthesia poses high risk for the patients.
Dexmedetomidine, ketamine, propofol intravenous infusion and other agents was used to provide monitored anesthesia care with variable success if used as solitary agents as each drug has its limited use.
详细描述
- Null hypothesis (H0): There are no differences between the effects of dexmedetomidine- ketamine and dexmedetomidine- propofol combination for monitored anesthesia care during burr-hole surgery for chronic subdural hematoma evacuation.
- Alternative hypothesis (H1): There are differences between the effects of dexmedetomidine- ketamine and dexmedetomidine- propofol combination for monitored anesthesia care during burr-hole surgery for chronic subdural hematoma evacuation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient acceptance.
- •Both sex.
- •Age (50-80) years old.
- •Patient with Body Mass Index (BMI) (25-30kg/m²).
- •American Society of Anesthesiologist (ASA) II / III
- •patient scheduled to burr-hole surgery for chronic subdural hematoma evacuation under MAC.
排除标准
- •Patient with difficult airway (mallapati III,IV).
- •Altered mental status (psychiatric and anexity disorder).
- •Post-traumatic stress disorders.
- •History of allergy to study drugs.
- •Patient on sedative or hypnotic medication.
- •Patients with on painkiller.
- •Patients with any degree of heart block.
- •Sever liver, respiratory or renal impairment.
研究组 & 干预措施
dexmedetomidine- ketamine
patients will receive combination of ketamine 1mg/kg and dexmedetomidine 1ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and ketamine 0.5 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture.
干预措施: dexmedetomidine- ketamine (Drug)
dexmedetomidine- propofol
patients will receive combination from 1 mg/kg propofol and dexmedetomidine 1ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and propofol 1 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture.
干预措施: dexmedetomidine- propofol (Drug)
结局指标
主要结局
The onset time of sedation
时间窗: with in 30 minutes before start of surgery
The onset of sedation will be recorded. It is defined as the time from injection of sedative medications till reaching a target sedation level score 3 by modified Observer's Assessment of Alertness and sedation score (OAA/S).
次要结局
- The extent of airway obstruction(intraopertive)
- number of participant with complications(intraoperative)
- Recovery time(with in one hour postoperative)
- surgeon satisfaction(with in 24 hours after surgery)
- rescue analgesic (fentanyl)(intraoperative)
- The Neurological status of participants(at baseline then within one hour postoperative)
研究者
Alshaimaa Abdel Fattah Kamel
principle investigator
Zagazig University