Magnesium Sulphate Versus Fentanyl as Adjuvants to Propofol Xylocaine Combination for Conscious Sedation During Chronic Subdural Haematoma Surgery. Comparative Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Total amount of Propofol consumption in each group
研究概览
简要总结
The investigators hypothesize that magnesium sulphate owing to its analgesic and sedative properties is not inferior to fentanyl in providing conscious sedation as adjuvants to propofol and local injection of lidocaine in patients undergoing surgery for evacuation of subdural haematoma. Consequently, the investigators are testing this hypothesis by comparing the sedative and analgesic effects of magnesium sulphate versus fentanyl as adjuvants to propofol lidocaine admixture for conscious sedation in patients undergoing burr hole surgery for evacuation of subdural haematoma.
详细描述
Following institutional ethical committee approval, 34 patients undergoing burr-hole surgery for chronic subdural hemorrhage were included in this prospective, randomized, double-blind study.
Written informed consent were obtained from all subjects before enrollment in the study.
During the preanesthetic checkup,the operative procedure and anesthetic techniques were explained to all patients.
Upon arrival to operating theater, standard monitoring were applied to all patients and bispectral index was applied before starting the drug infusions and was used for maintenance of sedation during operation.
Subjects were randomized into 2 groups. Magnesium (M) group received Magnesium sulphate 50mg/kg IV over 15 minutes Followed by continuous infusion at 15 mg/kg/h Fentanyl (F) group received fentanyl 1 μg /kg IV bolus over 15 minutes Followed by continuous infusion starting at 0.5 μg /kg/h Loading and infusion doses of magnesium sulphate and loading doses of fentanyl were chosen from previous studies.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 51 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 50 years
- •ASA (American Society of Anesthesiologists physical status) grade I to II
- •Glasgow coma scale 14-15
- •Unilateral chronic subdural hematoma
排除标准
- •Hypertension (diastolic blood pressure > 160 mmHg)
- •Bradycardia (<50 bpm)
- •Ischemic heart disease (<6 months)
- •Second- or third-degree heart block
- •Long-term abuse of or addiction to alcohol, tobacco, opioids, and sedative-hypnotic drugs (>6 months)
- •Allergy to study drugs
- •Neuropsychiatric diseases
- •Predicted difficult airway according to Ganzouri score >
- •Patients with deviation in the surgical technique or with inadequacy of local anesthesia were excluded from the study.
研究组 & 干预措施
Fentanyl (F) group
Fentanyl (F) group (n=17), in which fentanyl is given as adjuvant to propofol for sedation
干预措施: Fentanyl (Drug)
Magnesium (M) group
Magnesium (M) group (n=17) , in which magnesium sulphate is given as adjuvant to propofol for sedation
干预措施: Magnesium sulphate (Drug)
Magnesium (M) group
Magnesium (M) group (n=17) , in which magnesium sulphate is given as adjuvant to propofol for sedation
干预措施: Propofol (Drug)
Fentanyl (F) group
Fentanyl (F) group (n=17), in which fentanyl is given as adjuvant to propofol for sedation
干预措施: Propofol (Drug)
结局指标
主要结局
Total amount of Propofol consumption in each group
时间窗: From the start of propofol infusion after arrival to the operating room and throughout the duration of the surgery
To measure total amount of propofol consumption from induction of conscious sedation till the end of the operation and to compare it between both groups
次要结局
- To measure the total number of intraoperative patient's movements(From the start of the surgery and throughout the duration of the surgery)
- VAS score for pain(at skin closure and at 1hr, 2 hrs. 3hrs and 6 hrs. after PACU admission.)
- Time to first rescue analgesic(During the first 24 hours in the postoperative period)
- Heart rate(Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU)
- Non invasive blood pressure(Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU)
- To assess surgeon satisfaction score(30 minutes after the end of the surgery)
研究者
Rania Samir Fahmy
Lecturer of Anesthesia, surgical intensive care and pain mangement
Kasr El Aini Hospital