Intraoperative Lidocaine Versus Esmolol Infusion for Optimizing Surgical Field Visibility During Lumbar Discectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean arterial blood pressure
研究概览
简要总结
Intra-operative blood loss is an important attribution and predictor of the lumbar spine surgery and patient outcome. Stripping the muscle off bone makes more exposed bleeding spine surface is one of causes for blood loss during lumbar surgeries. The importance to decrease the bleeding is to improve the surgical field visibility which provides technical ease for surgeon and decreases the surgical time besides maintaining the hemodynamic stability. In past, there were many trials to minimize surgical blood loss by different drugs such as Na Nitroprusside, magnesium sulfate, volatile anesthetics and beta-adrenergic antagonist.
详细描述
Sample size:
Assuming mean and standard deviation of mean arterial pressure in lidocaine group versus esmolol group is 90±27.9 versus 73± 22.5 so the sample size will be 70 (35 in each group ) using Open Epi program with confidence level 95%, power of test 80% All patients will be hospitalized and visited a day before the surgery, full history with physical examination and routine investigation will be done, the nature and complications of the study will be explained in detail to the patient and informed written consent will be obtained from every participant.
All patients will be kept nil orally 6 hours before the operation. All surgeries will be done by the same surgeon to decrease observer's bias. The surgeon and the outcome assessor (anesthesiologist collect the data) will be blinded to study drugs.
Using computer generated randomization table, each group consists of 35 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
the outcome assessor the surgeon
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American society of anesthesiologist( ASA): I& II Physical status:
- •Body Mass Index( BMI)=(25-35 kg/m2).
- •Type of operations: lumbar discectomy.
- •Written informed consent from the patient.
排除标准
- •Patient refusal.
- •.Altered mental state
- •. Patients on beta-blockers or with a known history of allergy to study drugs.
- •Hepatic, renal, Cardiovascular and respiratory diseases.
- •Diabetic patients.
- •Patients receiving anticoagulants.
- •Previous spine surgery
研究组 & 干预措施
lidocaine
the Patient will receive IV bolus of 1.5mg/kg lidocaine 1% over ten minutes followed by continuous infusion of 1.5mg/kg/h
干预措施: Lidocaine (Drug)
esmolol
the Patient will receive IV bolus of esmolol 0.5 mg/kg over ten minutes followed by continuous infusion of 100-300 ug/kg/min
干预措施: Esmolol (Drug)
结局指标
主要结局
Mean arterial blood pressure
时间窗: from induction of anesthesia till the end of surgery
automatically invasive measured every 3 minutes , recorded every 15 minutes till the end
The quality of surgical field visibility
时间窗: from the start of surgery till the end of surgery
using the surgical field rating (SFR) scale of six points proposed by (Fromme et al 1986) : Grade 0: No bleeding - virtually bloodless field. Grade 1: Slight bleeding so no suctioning required. Grade 2: Slight bleeding so occasional suctioning required. Grade 3: Low bleeding- frequent suctioning required; bleeding threatens surgical field some seconds after suction is removed. Grade 4: Moderate bleeding- frequent suctioning required, bleeding threatens surgical field directly after suctioning. Grade 5: Sever bleeding so constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery hardly possible.
次要结局
- surgeon satisfaction("at completion of operation, an average 2 hours ")
- heart rate(15 minutes after the start of hypotensive agent)
- The need for blood transfusion("through study completion, an average of four months".)
- the amount of blood loss(from the beginning of surgery till the end of surgery, an average two hours")
- simplified postoperative nausea and vomiting(for the first 24 hours postoperative)
研究者
olfat abd elmoniem ibrahem
principle investigator
Zagazig University