The Effect of Intraoperative Administration of Dexmedetomidine, Propofol and Midazolam on Postoperative Levels of Inflammatory Markers and Development of Postoperative Cognitive Dysfunction After Pertrochanteric Fracture Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative inflammation measured by serum IL-6 levels
研究概览
简要总结
This study will examine the effect of intraoperative sedation with midazolam, propofol and dexemdetomidine on the occurrence of postoperative cognitive impairment in patients undergoing surgical treatment of pertrochanteric fracture of the femur.
详细描述
Patients undergoing surgical treatment of pertrochanteric femoral fracture by intramedullary fixation will be included in the study. Patients will be older than 65 years and will belong to class I to III anesthesia risk according to the ASA classification. All patients included in the study will sign informed consent. Patients with dementia, mental illness, psychoorganically altered patients, and patients with a contraindication to dexmedetomidine, propofol, midazolam or with a contraindication to spinal anesthesia will be excluded from the study. All patients included in the study will have their blood taken for laboratory analysis of red blood cells, leukocytes, CRP, PCT, ChE and IL-6. Analyzes will be performed before the procedure, on the 1st, 3rd and 5th postoperative day. All patients will be tested for Mini mental state exame (MMSE) score before surgery to rule out pre-existing cognitive impairment, and those patients who have an MMSE value <17 prior to surgery will be excluded from the study. In premedication, patients will be randomized using three envelopes selected by the blind researcher for the contents of each envelope. According to envelope patients will be divided into three groups: dexmedetomidine group (DS), propofol group (PS) and midazolam group (MS). Neuroaxial spinal block with intrathecal administration of 12.5 - 15 mg 0.5% levobupivacaine in the intervertebral space L3 / L4 or L4 / L5 will be the technique of anesthesia. After spinal block, patients in the DS group will receive a continuous infusion of dexmedetomidine at a dose of 0.5 mcg / kg / h, patients in the PS group will receive a continuous infusion of propofol at a dose of 25-75 mcg / kg / min, while patients in the MS group will receive 0.05-0.07 mg / kg bolus i.v. midazolam. The total dose administered and the duration of surgery will be recorded. The volume of intraoperatively administered crystalloids or blood products will be recorded in all patients included in the study. In the postoperative period, pain will be measured with a numerical rating scale (NRS) 4, 8, 12 and 24 hours after surgery. All patients will receive the usual postoperative analgesia with metamizole and tramadol according to the protocol of the Department. On the 1st, 3rd and 5th postoperative days in the morning between 8.00 and 10.00, all patients will be tested for MMSE and Digit Symbol Substitution Test (DSST) score. A researcher who will evaluate MMSE and DSST values in the postoperative period will be blind to the drug that patients received intraoperatively.
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, Care Provider)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pertrochanteric fracture surgery
- •Informed consent signed
排除标准
- •MMSE before surgery < 17
- •Allergy on midazolam, propofol or dexemdetomidine
- •Contraindication for neuroaxial anesthesia
研究组 & 干预措施
Midazolam
For sedation during surgery, patients will receive i.v. midazolam in dose 0.05 - 0.07 mg/kg.
干预措施: Mini mental state exame (MMSE) (Behavioral)
Midazolam
For sedation during surgery, patients will receive i.v. midazolam in dose 0.05 - 0.07 mg/kg.
干预措施: Digit Symbol Substitution Test (DSST) (Behavioral)
Midazolam
For sedation during surgery, patients will receive i.v. midazolam in dose 0.05 - 0.07 mg/kg.
干预措施: Numeric rating Scale (NRS) (Diagnostic Test)
Midazolam
For sedation during surgery, patients will receive i.v. midazolam in dose 0.05 - 0.07 mg/kg.
干预措施: Postoperative inflammation (Diagnostic Test)
Midazolam
For sedation during surgery, patients will receive i.v. midazolam in dose 0.05 - 0.07 mg/kg.
干预措施: Midazolam (Drug)
Propofol
For sedation during surgery, patients will receive i.v. propofol in dose 25-27 mcg/kg/min.
干预措施: Mini mental state exame (MMSE) (Behavioral)
Propofol
For sedation during surgery, patients will receive i.v. propofol in dose 25-27 mcg/kg/min.
干预措施: Digit Symbol Substitution Test (DSST) (Behavioral)
Propofol
For sedation during surgery, patients will receive i.v. propofol in dose 25-27 mcg/kg/min.
干预措施: Numeric rating Scale (NRS) (Diagnostic Test)
Propofol
For sedation during surgery, patients will receive i.v. propofol in dose 25-27 mcg/kg/min.
干预措施: Postoperative inflammation (Diagnostic Test)
Propofol
For sedation during surgery, patients will receive i.v. propofol in dose 25-27 mcg/kg/min.
干预措施: Propofol (Drug)
Dexmedetomidin
For sedation during surgery, patients will receive i.v. dexmedetomidin in dose 0.5 mcg/kg/h
干预措施: Mini mental state exame (MMSE) (Behavioral)
Dexmedetomidin
For sedation during surgery, patients will receive i.v. dexmedetomidin in dose 0.5 mcg/kg/h
干预措施: Digit Symbol Substitution Test (DSST) (Behavioral)
Dexmedetomidin
For sedation during surgery, patients will receive i.v. dexmedetomidin in dose 0.5 mcg/kg/h
干预措施: Numeric rating Scale (NRS) (Diagnostic Test)
Dexmedetomidin
For sedation during surgery, patients will receive i.v. dexmedetomidin in dose 0.5 mcg/kg/h
干预措施: Postoperative inflammation (Diagnostic Test)
Dexmedetomidin
For sedation during surgery, patients will receive i.v. dexmedetomidin in dose 0.5 mcg/kg/h
干预措施: Dexmedetomidin (Drug)
结局指标
主要结局
Postoperative inflammation measured by serum IL-6 levels
时间窗: 5 days
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum levels IL-6 at postoperative day 1, 3 and 5. Continuous increase of IL-6 in postoperative serial measurements will be considered as systemic inflammation state.
Postoperative inflammation measured by serum PCT levels
时间窗: 5 days
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum levels of PCT at postoperative day 1, 3 and 5. PCT \> 0.5 ng/ml and continuous increase in postoperative serial measurements will be considered as systemic inflammation state.
Occurrence of postoperative cognitive dysfunction (POCD) measured by MMSE
时间窗: 5 days
The incidence of POCD with respect to intraoperative sedation in the postoperative period will be measured by MMSE test on the first, third and fifth postoperative day. An absolute z-score greater than 1.96 in postoperative testing or a decrease in the postoperative MMSE value by more than 20% relative to the preoperative value will be considered the occurrence of POCD in the postoperative period.
Occurrence of postoperative cognitive dysfunction (POCD) measured by DSST
时间窗: 5 days
The incidence of POCD with respect to intraoperative sedation in the postoperative period will be measured by DSST on the first, third and fifth postoperative day. An absolute z-score greater than 1.96 in postoperative testing or a decrease in the postoperative DSST value by more than 20% relative to the preoperative value will be considered the occurrence of POCD in the postoperative period.
Postoperative inflammation measured by serum CRP levels
时间窗: 5 days
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum levels of CRP at postoperative day 1, 3 and 5. CRP \> 50 mg/L and rising dynamic of CRP in postoperative serial measurements will be considered as systemic inflammation state.
Postoperative inflammation measured by white blood cells count
时间窗: 5 days
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum levels of white blood cells. Leukocytes \> 12.000/mm3 or \< 4.000/mm3 in postoperative serial measurements will be considered as systemic inflammation state.
Postoperative inflammation measured by serum cholinesterase activity
时间窗: 5 days
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum cholinesterase activity at postoperative day 1, 3 and 5. Cholinesterase activity \< 4000 U/L in postoperative serial measurements will be considered as systemic inflammation state.
次要结局
- Postoperative pain(24 hours)