haemodynamic effect of subarachnoid block using hyperbaric bupivacaine versus isobaric ropivacaine in patients undergoing transurethral resection of prostate: a double blind randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Haemodynamic effects (hypotension) in the intraoperative period
研究概览
简要总结
Spinal anaesthesia is a technique involving the introduction of local anaestheticsinto the subarachnoid space. Currently, bupivacaine, a long-acting localanaesthetic, is the agent of choice for spinal anaesthesia. Althoughbupivacaine provides dense motor and sensory block, it can be associated withsignificant cardiovascular side effects, particularly hypotension andbradycardia. Ropivacaine, another long-acting anaesthetic like bupivacaine, isbecoming a popular alternative. It, reportedly has fewer cardiovascular sideeffects and is more selective for blockage of sensory fibres than motor andautonomic fibres. This property allows patients to regain mobility sooner,reduces urinary retention, and even makes spinal anaesthesia feasible forsame-day discharge after surgery.
In theproposed randomized controlled trial, we aim to evaluate the haemodynamicstability of isobaric (0.75%) ropivacaine versus hyperbaric (0.5%) bupivacaine(control) for subarachnoid block in patients undergoing transurethral resectionof prostate. The study will be carried out in 100 subjects divided into twogroups of 50 each as bupivacaine and ropivacaine group. We will administer 2 mlof equipotent dose of the respective drug (10 mg of bupivacaine or 15 mg ofropivacaine) in each group and record their haemodynamic parameters (heartrate, systolic blood pressure, diastolic blood pressure, mean arterialpressure) using standard multipara monitor with appropriate sized (bladderlength 80% of the patient’s arm circumference, and the bladder width >= 40%of the arm circumference) non invasive blood pressure cuff every 5 min for theintraoperative period, then every 15 min in postoperative period for 3 hourstotal. Hear rate will be monitored continuously and recorded as an average oflast 4 secs every 5 min the intraoperative period, then every 15 min in thepostoperative period for 3 hours total. Our objective is to compare thehaemodynamic effects in the intraoperative period.
By comparing the haemodynamic effects of these drugs, we can make moreinformed decisions to minimize complications associated with spinalanaesthesia.
We hypothesize that ropivacaine would provide amore hemodynamically stable spinal anaesthesia than bupivacaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Age- 50 to 75 years 2.Body Mass Index (BMI)- 18-30 kg/m2 3.American Society of Anaesthesiology (ASA) Grade.
排除标准
- •1.Inability to obtain written informed consent 2.History of hypersensitivity to local or systemic anaesthetic agents 3.Patient already on any vasopressor 4.Preoperative bradycardia or tachycardia or hypotension 5.Failure of subarachnoid block.
结局指标
主要结局
Haemodynamic effects (hypotension) in the intraoperative period
时间窗: every 5 min in the intraoperative period and then every 15 min in the postoperative period for a total of 3 hours followinng subarachnoid block
次要结局
- 1.Bradycardia & tachycardia in the intraoperative period(heart rate will be monitored continuously & recorded every 5 min for the intraoperative period & then every 15 min in the postop period for 3 hours)
- 2.Cumulative dose of vasopressor in the intraoperative period(Total dose of vasopressor needed in the intraoperative period will be recorded by the investigator after each operation is completed)
- 3.Level of sensory block assessed on 5 & 10 min after subarachnoid block administration(5min, 10 min following subarachnoid block)
- 4.Duration of sensory block assessed in the postop period hourly up to 8 hours(1st hour, 2nd hour, 3rd hour, 4th hour, 5th hour, 6th hour, 7th hour, 8th hour following subarachnoid block)
- 5.Degree of motor block assessed using modified Bromage scale assessed on 5 min & 10 min after subarachnoid block administration(5min, 10 min following subarachnoid block)
- 6.Duration of motor block assessed using modified Bromage scale done hourly in the postoperative period up to 8 hours(1st hour, 2nd hour, 3rd hour, 4th hour, 5th hour, 6th hour, 7th hour, 8th hour following subarachnoid block)