Effect of Two Different Doses of Intrathecal Dexmedetomidine as Adjuvant Combined With Hyperbaric Bupivacaine in Elderly Patients Undergoing Transurethral Resection of Prostate: A Prospective, Randomized Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The duration of analgesia
研究概览
简要总结
Transurethral resection of the prostate (TURP) is the most common Surgical intervention for elderly patients with benign prostatic hyperplasia. Spinal anesthesia is the technique of choice in TURP.Intrathecal (IT)adjuvants prolong the duration of spinal anesthesia and postoperative analgesia there by reducing the requirement of postoperative supplement analgesics .The incorporation of adjuvants also lowers the overall dose of local anesthetic and associated side effects .
The extended analgesic efficacy of intratheacal dexmedetomidine in the postoperative period has been shown in a few clinical studies . These authors have studied different doses (2 - 10 μg) of intrathecal dexametomedine and compared it with various other adjuvants like clonidine, fentanyl, midazolam, buprenorphine, etc., with varying results . The existing studies comparing different doses of intratheacal dexmedetomidine are few. Moreover none of these studies have stressed the dose-response relationship between different doses of intratheacal dexmedetomidine and differential analgesia (DA) defined as the time difference from the offset of motor blockade to the first analgesic requirement on numerical rating scale more than4.
详细描述
The study hypothesis is that there may be a dose dependent prolongation of dexametomedine with escalating doses of intrathecal dexmedetomidine.In this study we tried to find out the optimum safe dose of dexametomedine that used as adjuvant with bupivacaine for patient undergoing transuretheral reseaction of large sized prostate.
The aim of the current study is to To elucidate the dose-response relationship between intrathecal dexametomedine with different doses and subarachnoid block characteristics, particularly the duration of analgesia and differential analgesia. Considering the dose dependent action of intrathecal dexametomedine, the authors could hypotheize that the higher dose of dexametomedine (10 μg) used as adjuvant with bupivacaine will result in better efficacy profile with further prolongation of sensory motor blockade in elderly patient undergoing transurethral resecation of large sized prostate if compared with dexametomedine (5 μg).
After obtaining approval from Mansoura Faculty of Medicine Institutional Research Board about This study which will be a double blinded, prospective, randomized, trial. This study will be carried out in the Urology and Nephrology center of Mansoura university (MUCH). An informed written consent will be obtained from all patient.
This study will be conducted on 70 patients 55- 85 years of age, American Society of Anesthesiologists (ASA) physical status I/II scheduled for transurethral reasection of prostate .
The study subjects will be randomly assigned to one of two equal groups (dexmedetomidine5 μg group and dexmedetomidine 10 μg group ) using computer generrated randomization members Dexmedetomidine 5 μg group (D5 group ): Patients will receive 2 mL heavy bupivacaine 0. 5% and Dexmedetomidine 5 μg dexmedetomidine 10 μg group (D10 group ): Patients will receive 2 mL heavy bupivacaine 0. 5% and Dexmedetomidine 10 μg All patients will be subjected to preoperative assessment that includes thorough clinical examination, radiological and laboratory workup. Laboratory investigations will include complete blood count (CBC), serum electrolytes, arterial blood gas, urine analysis, coagulation survey, blood glucose level, liver and renal function tests. ECG, transthoracic echocardiography and chest x-ray will be done.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
double- blind
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Elderly patients undergoing transurtheral resection of Prostate.
- •American Society of Anesthesiologists (ASA) physical status I/II
排除标准
- •Any contraindication to subarachnoid block.
- •On chronic analgesic therapy.
- •Patients refuse to contribute in the study.
- •Cognitive impairment.
- •Not able to understand numerical rating pain scale (NRS). 6.-Significant comorbid conditions like uncontrolled hypertension, congestive heart failure myocardial infarction in the past 6 months..
研究组 & 干预措施
Dexmedetomidine 5 μg group (D5 group )
Dexmedetomidine 5 μg group (D5 group ): Patients will receive 2 mL heavy bupivacaine 0.5% and Dexmedetomidine 5 μg intrathecal.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 10 μg group (D10 group )
dexmedetomidine 10 μg group (D10 group ): Patients will receive 2 mL heavy bupivacaine 0.5% and Dexmedetomidine 10 μg intrathecal .
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The duration of analgesia
时间窗: perioperative time for 24 hours
Duration of spinal analgesia till analgesic rescue.
次要结局
- Onset of sensory block after spinal anesthesia .(Immediate after spinal anesthesia)
- Differential analgesia(Perioperative time for 24 hours.)
- Perioperative hypotension(Perioperative time for 24 hours postoperatively)
- Hemodynamic stability perioperatively.(perioperative time for 24 hours)
- Total dose of analgesic requirements .(perioperative time for 24 hours)
- Dose of vasopressors required(perioperative time for two hours postoperatively)
研究者
Mahmoud Mahmoud Othman
Clinical professor of anesthesia and surgical Intensive care
Mansoura University