Study on comparison of prophylactic phenylephrine infusion versus intravenous ramosetron on hypotension during spinal anaesthesia for herniorhhaphy , hernioplasty : A Randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
-  To compare the efficacy of intravenous phenylephrine infusion(25 μg.min−1) versus intravenous Ramosetron(0.3mg) versus 0.9% Normal saline (placebo) infusion in the prevention of hypotension post spinal anaesthesia for patients undergoing elective surgery for inguinal hernia i.e. herniorhhaphy/hernioplasty.
研究概览
简要总结
Spinal anaesthesia is the most commonly used anaesthetic technique for elective herniorhhaphy/hernioplasty . It has many advantages over other techniques; it is quicker , easier and less invasive compared to epidural anaethesia and general anaesthesia . also the patient is exposed to less drugs compared to general anaesthesia. However, spinal anaesthesia has multiple drawbacks. It can induce hypotension, which leads to nausea, vomiting, and dizziness. It also causes post spinal shivering in many patients
Multiple interventions have been proposed to prevent the incidence of such complications including intravenous fluid infusion, leg compression, and vasopressors (norepinephrine, ephedrine, phenylephrine, mephentermine). Furthermore, a previous study has reported that 5-HT3 receptor antagonists such as ondansetron , ramosetron can prevent hypotension by preventing serotonin induced bradycardia.
So this study is being conducted to compare the efficacy of prophylactic phenylephrine infusion ( 25 mcg/min ) versus single prophylactic dose of intravenous ramosetron ( 0.3 mg ) on the incidence of hypotension post spinal anaesthesia in patients undergoing elective herniorhhaphy/hernioplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patient ASA status type I or II.
- •Patient of inguinal hernia undergoing Elective Surgery requiring spinal anaesthesia.
- •Patient height between 160 c.m. – 170 c.m.
排除标准
- •Patient having known allergy to any of medication to be used in the study(phenylephrine and ramosetron).
- •Emergency cases.
- •Patient having other comorbidities.
- •ASA status type 3 and 4.
结局指标
主要结局
 To compare the efficacy of intravenous phenylephrine infusion(25 μg.min−1) versus intravenous Ramosetron(0.3mg) versus 0.9% Normal saline (placebo) infusion in the prevention of hypotension post spinal anaesthesia for patients undergoing elective surgery for inguinal hernia i.e. herniorhhaphy/hernioplasty.
时间窗: pre induction | post spinal puncture | At every 2 minutes interval for first 15 minutes | Then at every 5 minutes for next 15 minutes | Then at every 10 minutes interval for rest of duration of surgery.
Mean Arterial pressure , systolic and diastolic blood pressure and Heart rate will bw measured.
时间窗: pre induction | post spinal puncture | At every 2 minutes interval for first 15 minutes | Then at every 5 minutes for next 15 minutes | Then at every 10 minutes interval for rest of duration of surgery.
次要结局
- To compare the incidence of episodes of nausea and vomiting between three groups.
- To compare the incidence of episodes of skin flushing and other patient discomfort between three groups.
研究者
DR SACHIN KUMAR
RAJENDRA INSTITUTE OF MEDICAL SCIENCES