Effect of Dexmedetomidine/Lidocaine, Ketamine/Lidocaine and Lidocaine Alone on Proinflammatory Cytokines in Pelvi-abdominal Cancer Surgeries: Randomised Prospective Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Serum pro-inflammatory cytokines (IL-1, IL-6, TNFα).
研究概览
简要总结
The investigators hypothesize that effect of addition of dexmedetomidine or ketamine by IV infusion to lidocaine infusion may be more beneficial than lidocaine infusion alone on proinflammatory cytokines (IL-1, IL-6 and TNFα), and postoperative pain relief and decreased opioid consumption, reduced Length of stay.
详细描述
45 female patients of American Society of Anesthesiologists (ASA) physical status I or II, aged (40-70) years admitted to department of obstetrics and gynecology, El shatby University Hospital and scheduled for elective pelvi- abdominal cancer surgery. Patients will be randomly allocated using a computer generated random table (Graphpad Software, Inc, La Jolla, CA) and an allocation ratio of 1:1 using a sealed envelope method to one of three groups. The envelope will be opened by an observer not involved in the study. Patients will be divided into three equal groups. Group L (n=15): Patients will receive 1.5mg /kg lidocaine 2%; intravenously as a bolus dose then 1.5mg/kg/hr lidocaine infusion using a 50cc syringe pump intra-operatively. Group LK (n=15): Patients will receive same infusion regimen of lidocaine 2%; as in group L plus 0.35 mg/kg ketamine intravenously as a bolus dose, followed by intravenous infusion of 0.2 mg/kg/h using a 50cc syringe pump intra- operatively. Group LD (n=15): Patients will receive same infusion regimen of lidocaine 2%; as in group L plus 0.5 μg/kg dexmedetomidine intravenously as a bolus dose, followed by intravenous infusion of 0.4 μg/kg/h using a 50cc syringe pump intra-operatively. During preoperative visit, evaluation of patients will be carried out through proper history taking, clinical examination and routine laboratory investigations including complete blood picture, coagulation profile, blood urea, serum creatinine, serum electrolytes (sodium, potassium and calcium), fasting blood glucose, liver function tests and any other investigation needed.
- Informed written consent, from all individual participants who will be included in this study will be taken during preoperative visit.
- The patient will be trained during preoperative visit on a visual analogue scale (VAS) for pain, with 0 corresponding to no pain and 10 to the worst pain imaginable.
Pre-anaesthetic preparation and premedication:
- Fasting hours (6 hours to solids and 2 hours for clear fluids).
- Thrombotic prophylaxis (enoxaparin 40 mg) will be started 12 hours before surgery.
- Antiseptic shower will be taken.
- Elastic stockings will be worn.
- Antibiotic prophylaxis: single dose ceftriaxone 2 g intravenously will be given 1 hour before surgical incision according to hospital policy.
On arrival to the operative theater:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-70 years.
- •Female patients.
- •ASA physical status class I or II.
- •Elective resectable pelvi-abdominal cancer.
排除标准
- •Patients with history of sensitivity to the studied drugs.
- •Patients with cardiac conduction defects.
- •Impaired kidney or liver function.
- •Psychiatric disease or seizure disorder requiring medication within the previous 2 years.
- •Opioid tolerant patient.
- •Patient receiving nonsteroidal anti-inflammatory drugs within 1 week of surgery.
- •Patient receiving B blockers, α2 ad-renergic agonist, sedatives, and antiarrythemic drugs.
- •Cognitive dysfunction.
- •Any history of antitumor treatments before surgery.
研究组 & 干预措施
Group L receiving intravenous lidocaine infusion only
Patients will receive 1.5mg /kg lidocaine 2%; intravenously as a bolus dose then 1.5mg/kg/hr lidocaine infusion using a 50cc syringe pump intra-operatively.
干预措施: Lidocaine Intravenous Infusion (Drug)
Group LK receiving lidocaine and ketamine infusion
Patients will receive same infusion regimen of lidocaine 2%; as in group L plus 0.35 mg/kg ketamine intravenously as a bolus dose, followed by intravenous infusion of 0.2 mg/kg/h using a 50cc syringe pump intra- operatively.
干预措施: Lidocaine and ketamine (Drug)
Group LD receiving lidocaine and dexmedetomidine infusion
Patients will receive same infusion regimen of lidocaine 2%; as in group L plus 0.5 μg/kg dexmedetomidine intravenously as a bolus dose, followed by intravenous infusion of 0.4 μg/kg/h using a 50cc syringe pump intra-operatively.
干预措施: lidocaine and dexmedetomidine infusion (Drug)
结局指标
主要结局
Serum pro-inflammatory cytokines (IL-1, IL-6, TNFα).
时间窗: Preoperative, 2 hours after recovery and after 24 hours
次要结局
- • Pulse rate (Beats / min).(Intraoperative)
- Propofol consumption at induction (mg).(Intraoperative)
- Post-operative pain score.(Visual analogue scale will be assessed every 2 hours postoperatively for 8 hours then at 12, 18 and 24 hours postoperatively.)
- Time to first postoperative analgesic request (min).(First 24 hours)
- Perioperative analgesic consumptions.(First 24 hours)
- Recovery profiles.(Postoperative upto 60 minutes)
- Length of hospital stay in days.(Upto 14 days after surgery)
- Adverse effects(First 24 hours)
- • Non-invasive measurement of mean arterial blood pressure (in mmHg).(Intraoperative)
- • Pulse oxygen saturation. (SpO2%)(Intraoperative)
- Average end tidal concentration of isoflurane (%).(Intraoperative)
- Intraoperative fentanyl requirements (μg).(Intraoperative)
研究者
Bassem Emad
Assistant lecturer
Alexandria University